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+Female patients of childbearing potential must agree to use 2 adequate methods of contraception with their partner starting with the screening visit through 150 days after the last dose of study therapy.
+Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug
+Males or females of reproductive potential may not participate unless they have agreed to practice 1 highly effective and 1 additional effective (barrier) method of contraception at the same time during the entire study treatment period and through 4 months after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception
+Women of childbearing age should avoid becoming pregnant while taking any mTOR inhibitor including MLN0128 (TAK-228)\r\n*Female patients must:\r\n** Be postmenopausal for at least 1 year before the screening visit, OR\r\n** Be surgically sterile, OR\r\n** If they are of childbearing potential, agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated by local labeling [e.g., United States product insert [USPI], summary of product characteristics [SmPC], etc.;]) after the last dose of study drug, OR \r\n** Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient; NOTE: periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together\r\n* Male patients, even if surgically sterilized (i.e., status postvasectomy), must:\r\n** Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR \r\n** Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (NOTE: periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)\r\n** AND agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female patients of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 6.4.5.3, for the course of the study through 120 days after the last dose of study medication. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.
+Male patients of childbearing potential must agree to use an adequate method of contraception as outlined in Section 6.4.5.3, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.
+Female subjects of childbearing potential must be willing to use an adequate method of contraception; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects agree to remain abstinent or use a condom plus an additional contraceptive method that result in a failure rate of < 1% per year during sexual contact with a female of childbearing potential while participating in the study, during dose interruptions, and for 31 weeks following the last dose of the study treatment, even if he has undergone a successful vasectomy; abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient; periodic abstinence and withdrawal are not acceptable
+Female subject of childbearing potential should have a negative serum pregnancy test performed during the screening period\r\n* Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of reproductive potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy; NOTE: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+For men: agreement to remain abstinent or use a contraceptive method that results in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug; abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal or postovulation methods) and withdrawal are not acceptable methods of contraception
+Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male patient with a partner of childbearing potential agrees to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+COHORT 1: Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication\r\n* NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+COHORT 1: Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+COHORT 2: Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication\r\n* NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+COHORT 2: Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects without a previous vasectomy should agree to use an adequate method of contraception (i.e. abstinence, condom with spermicidal foam/gel/film/cream) starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice two effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Female patients must meet one of the following criteria:\r\n* Postmenopausal for at least 1 year prior to registration \r\n* Surgically sterile\r\n* Of childbearing potential and agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug\r\n* Of childbearing potential and agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject\r\nNOTE: periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
+Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject\r\nNOTE: periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
+Male subjects must agree to practice contraception for at least 90 days after the last dose of carfilzomib, and must agree not to donate sperm for at least 90 days after the last dose of carfilzomib
+Female participants of non-childbearing potential must be willing to use adequate contraceptive measures from the Screening Visit (Visit 1) through 120 days after the last dose of study drug; male participants must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug
+Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit\r\n* Are surgically sterile\r\n* If they are of childbearing potential, agree to practice 1 effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer as mandated by local labeling [e.g., United States product insert (USPI), summary of product characteristics (SmPC), etc,]) after the last dose of study drug\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)
+Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:\r\n* Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)\r\n* Agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug
+If male, must agree to use contraception or practice abstinence as well as refrain from donating sperm for at least 180 days after the last dose of study treatment.
+Female and Male subjects of childbearing potential must be willing to use an adequate method of contraception, starting with the first dose of study drug through 4 weeks after the last dose of study drug. Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
+Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Subject is willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug (male and female participants of childbearing potential)
+Female and male participants of reproductive potential must agree to use contraception starting from the first dose of study medication, throughout the study period, and for up to 120 days after the last dose of study medication
+Non-pregnant; women of childbearing potential must have a negative pregnancy test (human chorionic gonadotropin [HCG] serum or urine) within 30 days prior to study registration and to be repeated if not done within 7 days of starting chemotherapy; female subjects participating in this study should avoid becoming pregnant, and male subjects should avoid impregnating a female partner; non-sterilized female subjects of reproductive age and male subjects should use effective methods of contraception through defined periods during and after study treatment as specified below\r\n* Female subjects must meet one of the following:\r\n** Natural postmenopausal before the screening visit defined as no menses at any time in the preceding 12 consecutive months, or\r\n** Prior bilateral oophorectomy or bilateral tubal ligation, or\r\n** If they are of childbearing potential, agree to practice two effective methods of contraception per discussion with the treating physicians from the time of signing of the informed consent form through three months after the last dose of study drug, or\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post ovulation methods] and withdrawal are not acceptable contraception methods)\r\n* Male subjects, even if surgically sterilized (i.e., status post vasectomy) must agree to one of the following:\r\n** Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose, or\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post ovulation methods] and withdrawal are not acceptable methods of contraception)
+Fertile men must also agree to use adequate contraception (2 barrier methods or abstinence) during the study and for up to 4 months after the last dose of study drug
+Agree to use two reliable forms of contraception simultaneously or to practice complete abstinence (True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence [eg calendar, ovulation, symptothermal or post-ovulation methods] and withdrawal are not acceptable methods of contraception.) from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting CC-122; 2) while taking CC-122; 3) during dose interruptions; and 4) for at least 28 days after the last dose of CC-122 as specified in the Pregnancy Prevention and Risk Management Plan (PPRMP)
+Practice complete abstinence (True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence [eg calendar, ovulation, symptothermal or post-ovulation methods] and withdrawal are not acceptable methods of contraception.) or agree to use a condom during sexual contact with a pregnant female or a FCBP for at least 12 months after the last dose of rituximab.
+Male patients with WOCBP partners and female patients of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 7 months (male participants) or 5 months (female participants) after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.
+The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
+Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Negative serum pregnancy test done ? 7 days prior to registration, for women of childbearing potential only
+Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Female and male subjects of childbearing potential must agree to use an adequate method of contraception, prior to study entry, for the duration of study participation, and 4 months after completion of pembrolizumab administration; contraception is required starting with the first dose of study medication through 120 days after the last dose of study medication\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Female and male subjects of childbearing potential must agree to use an adequate method of contraception; contraception is required prior to study entry and for the duration of study participation and 4 months after completion of pembrolizumab administration; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Female and male subjects of childbearing potential must agree to use an adequate method of contraception; contraception is required starting with the first dose of study medication through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Men who are not surgically sterile (vasectomy) must agree to use an acceptable method of contraception. Male subjects with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must agree to use condoms from the first dose of study drug through at least 120 days after the last dose of study drug. Total abstinence for the same study period is an acceptable alternative.
+Female subjects (unless postmenopausal for at least 1 year before the screening visit, or surgically sterilized), agree to practice two (2) effective methods of contraception at the same time, or agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception) through 90 days after the last dose of maintenance therapy (see Section 2.6.2 for definition of postmenopausal).
+Male subjects (even if surgically sterilized) must agree to one of the following: practice effective barrier contraception (see Section 2.6.4.1 for list of barrier methods), or practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of from the time of signing the informed consent through 90 days after last dose of maintenance therapy.
+Male participants of reproductive potential must agree to use an adequate method of contraception starting with the first dose of study medication through 120 days after the last dose of study medication
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condom should not be used together).
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient
+Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy during the entire study treatment period and through 90 days after the last dose of study drug OR agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 26 weeks after the last dose of study therapy
+Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following protocol discontinuation, even if he has undergone a successful vasectomy\r\n* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception)
+Male patient with a partner of childbearing potential agrees to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female subjects of childbearing potential should be willing to use adequate method of contraception for the course of the study through 120 days after the last dose of study medication; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year; the two birth control methods can be two barrier methods or a barrier method plus a hormonal method to prevent pregnancy; subjects should start using birth control from the screening visit throughout the study period up to 120 days after the last dose of study therapy; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects should agree to use an adequate method of contraception starting with D1 of HiDAC through 120 days after the last dose of study therapy; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose pembrolizumab and 180 days after the last dose of cetuximab
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female patients must meet one of the following:\r\n* Postmenopausal for at least 1 year before the screening visit, OR\r\n* Surgically sterile, OR\r\n* If they are of childbearing potential:\r\n** Agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.) Male participants, even if surgically sterilized (ie, status postvasectomy), who:
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
+Non-pregnant and non-lactating\r\n* Female patients who:\r\n** Are postmenopausal for at least 1 year before the screening visit, OR\r\n** Are surgically sterile, OR\r\n** If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male subjects must agree to use one of the methods of contraception specified. This method must be used from the time of the first dose of study medication until 16 weeks after the last dose of study medication. In addition, male subjects whose partners are or become pregnant must continue to use condoms for 7 days after stopping study medications.
+Willing to follow strict birth control measures as suggested by the study\r\n* Female patients: if they are of childbearing potential, agree to one of the following:\r\n** Practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
+Female participants of childbearing potential must agree to use adequate methods of contraception starting with the first dose of study therapy through 60 days after the last dose of study therapy. \r\n* Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year without an alternative medical cause. \r\n* Note: Abstinence is acceptable if this is the preferred contraception for the participant.
+Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 60 days after the last dose of study therapy. \r\n* Note: Abstinence is acceptable if this is the preferred contraception for the participant.
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 180 days after the last dose of study therapy
+Male and female subjects of child bearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication
+Willing to follow strict birth control measures;\r\n* Female patients: If they are of childbearing potential, agree to one of the following:\r\n** Practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 120 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+A male participant must agree to use a contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant
+Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n*Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n*Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Female patients who: Are postmenopausal for at least 1 year before the screening visit, OR are surgically sterile, OR if they are of childbearing potential, agree to practice 1 effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer as mandated by local labeling [e.g., United Surgical Partners International (USPI), summary of product characteristics (SmPC), etc,]) after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
+Male patients, even if surgically sterilized (i.e., status post-vasectomy), who: agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.) Agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug.
+Male subjects should agree to abstinence or use of an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male and female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study drug
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female subjects of childbearing potential must be willing to use an adequate method of contraception; contraception, for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Women of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Men of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
+Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential:\r\n** Agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug (female and male condoms should not be used together), OR\r\n** Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (i.e., status postvasectomy), who:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug (female and male condoms should not be used together), OR\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)
+Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study treatment through 120 days after the last dose of study treatment.
+Female subjects of childbearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication (note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject)
+Male subjects must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication (note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject)
+Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+All individuals must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 1 highly effective method and 1 additional (barrier) of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug (female and male condoms should not be used together), or\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only and lactational amenorrhea are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (ie, status postvasectomy), who:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug (female and male condoms should not be used together), or\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only and lactational amenorrhea are not acceptable methods of contraception)
+Willing to use adequate contraception while on the study and until 120 days after the last dose of study drug
+Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
+Female and male participants of childbearing potential must agree to use an adequate method of contraception; contraception is required starting with the first dose of study medication through 150 days (5 months) after the last dose of study medication; examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, established and proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices; the reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Female subjects of childbearing potential must be willing to use an adequate method of contraception; contraception should be used for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception; contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male patients must agree to use an adequate method of contraception, or to abstain from heterosexual activity (complete abstinence), starting with the first dose of study drug through 7 months after the last dose of study therapy
+Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
+Women of childbearing potential (WOCBP) must agree to use an adequate method of contraception during the study and until 3 months after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment. Adequate methods of contraception include: total abstinence when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
+Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication.\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
+Male subjects must agree to use an adequate method of contraception for the duration of the study through 120 days after the last dose of study therapy
+Male subjects must agree to practice contraception
+Be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication (male and female subjects of childbearing potential
+Male patients with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 24 weeks (6 months) after the last dose of study therapy
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following study drug discontinuation, even if he has undergone a successful vasectomy\r\n* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female subjects of childbearing potential must be willing to use an adequate method of contraception; contraception, for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception; contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Female subjects of childbearing potential must be willing to use an adequate method of contraception; contraception must be used for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+If male, agrees to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug
+Female subjects of childbearing potential must be willing to use an adequate method of contraception as outlined - contraception, for the course of the study through 120 days after the last dose of study medication. Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception as outlined - contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+For men: agreement to remain abstinent or use a barrier method of contraception (e.g., condom) during the treatment period and for at least 90 days after the last dose of study drug and agreement to refrain from donating sperm during this same period\r\n* Men with a pregnant partner must agree to remain abstinent or use a condom for the duration of the pregnancy\r\n* Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
+Persons of childbearing potential, agree to one of the following:\r\n* Practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Persons able to father a child: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+POCBP must be willing to use adequate contraception starting with first dose through 120 days after last dose
+Female subjects of childbearing potential must be willing to use an adequate method of contraception starting with the date of consent through 120 days after the last dose of study medication; NOTE: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the date of consent through 120 days after the last dose of study therapy; NOTE: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Patients of reproductive potential must be willing to practice highly effective methods of contraception throughout the study and for 120 days after the last dose of study medication. Abstinence is acceptable if this is the usual lifestyle of the patient.
+STUDY TREATMENT: Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy
+Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an effective method of contraception starting with the first dose of study therapy through the duration of treatment
+Male subjects capable of fathering a child must agree to use an adequate method of contraception starting with the first dose of the study drug through 120 days after the last dose of the study drug; male subjects will be considered to be capable of fathering a child unless they have azoospermia (whether due to having had a vasectomy or due to an underlying medical condition)
+Male patient with a partner of childbearing potential agrees to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male patients must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study therapy
+Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug
+Willing to use adequate contraception while on the study and until 120 days after the last dose of study drug
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects must agree to use adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of therapy
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
+Female patients who: are postmenopausal for at least 1 year before the screening visit, OR are surgically sterile, OR if they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception; MUST have a negative serum or urine pregnancy test within 7 days of initiating protocol treatment unless prior hysterectomy or menopause (defined as 12 consecutive months without menstrual activity); patients should not become pregnant or breastfeed while on this study; should a woman become pregnant or suspect she is pregnant, she should inform her treatment physician immediately; male patients, even if surgically sterilized (ie, status post-vasectomy), who: agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g. calendar, ovulation, symptothermal, post ovulation methods for the female partner] and withdrawal are not acceptable methods of contraception, or agree not to donate sperm during the course of this study or 120 days after receiving their last dose of study drug
+LYMPHODEPLETION: Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 3 months after the last dose of study therapy
+iC9-CAR19 CELL INFUSION: Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 3 months after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy; males must refrain from donating sperm during study participation and for 120 days after the last dose of study medication
+Willing to follow strict birth control measures\r\n* Female patients: if they are of childbearing potential, agree to one of the following:\r\n** Practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment specific pregnancy prevention program, if applicable, OR \r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR \r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male: use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy
+Female patients must be:\r\n* Postmenopausal for at least 1 year before the screening visit, OR\r\n* Surgically sterile, OR\r\n* If they are of childbearing potential\r\n** Agree to practice 1 highly effective method and one additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug (female and male condoms should not be used together), OR\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (i.e., status post-vasectomy) must:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug (female and male condoms should not be used together), or\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)
+Men treated or enrolled on this protocol must agree to use adequate contraception prior to the first dose of study therapy, for the duration of the study participation, and for 120 days after the last dose of study therapy
+Subjects should agree to use an adequate method of contraception prior to the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Their partners should also be encouraged to use proper method of contraception
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Adequate contraception as follows:\r\n* For women:\r\n** Postmenopausal for at least 1 year before the screening visit, OR\r\n** Surgically sterile, OR\r\n** If they are of childbearing potential, agree to practice 1 effective method of contraception, and 1 additional (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated by local labeling [e.g. United States Package Insert (USPI), Summary of Product Characteristics (SmPC), etc;]) after the last dose of study drug OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)\r\n* For men, even if surgically sterilized (i.e., status post-vasectomy), they must:\r\n** Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)\r\n** Agree not to donate sperm during the course of this study or 120 days after receiving their last dose of study drug
+Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study medication until 120 days after the final dose of study medicine; abstinence is acceptable if this is the established and preferred contraceptive method for the subject
+Male patients should agree to use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy, or documented to be surgically sterile
+Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male patients on treatment with TG02 must agree to use an adequate method of contraception for the duration of the study, and for 30 days after the last dose of study medication
+Males must agree to use an adequate method of contraception during the study and for at least 30 days after the last dose of study drug or Das
+Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Female subjects of childbearing potential must be willing to use an adequate method of contraception; contraception, for the course of the trial through 120 days after the last dose of trial drug; note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject; male subjects of childbearing potential must agree to use an adequate method of contraception; contraception, starting with the first dose of trial therapy through 120 days after the last dose of trial therapy
+Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male: use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Men must agree to practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following discontinuation of study therapy, even if he has undergone a successful vasectomy\r\n* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Males must agree to use an adequate method of contraception during the study and for at least 30 days after the last dose of study drug or LDAC
+Females of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must:\r\n* Either commit to true abstinence (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject; [periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception]) from heterosexual contact (which must be reviewed on a monthly basis), or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting investigational product (IP) therapy (including dose interruptions), and while on study medication or for a longer period if required by local regulations\r\nfollowing the last dose of IP; and\r\n* Have a negative serum pregnancy test (beta-hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, as per clinical judgement of the investigator, and after the end of study therapy; this applies even if the subject practices true abstinence from heterosexual contact
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Patients able to father a child must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* NOTE: Abstinence is acceptable if this is the established and preferred method of contraception for the subject
+Female patients who: are postmenopausal for at least 1 year before the screening visit, OR are surgically sterile, OR if they are of childbearing potential, agree to practice 1 effective method of contraception and one additional effective (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated bu local labeling [eg, United States Prescribing Information (USPI), Summary of Product Characteristics (SmPC), etc;]) after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g, calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only, ad lactational amenorrhea are not acceptable methods of contraception); female and male condoms should not be used together
+Male patients, even if surgically sterilized (ie, status post-vasectomy), who: agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal, spermicides only, ad lactational amenorrhea are not acceptable methods of contraception); female and male condoms should not be used together; agree not to donate sperm during the course of this study or 120 days after receiving their last dose of study drug
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+For women:\r\n* Postmenopausal for at least 1 year before the screening visit, OR\r\n* Surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception)
+For men, even if surgically sterilized (i.e., status post-vasectomy), they must:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception)\r\n* Agree not to donate sperm during the course of this study or 120 days after receiving their last dose of study drug
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 31 weeks after the last dose of study therapy
+Female subjects of childbearing potential must be willing to use adequate method of contraception; contraception, for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception; contraception, starting with the first dose of study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception during the course of the study and for 30 days after the last dose of the study drug
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy and continuing through the last dose of study therapy and for 90 days after the final dose of study drug
+Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+For men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug; abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
+Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Sexually active subjects and their partners must agree to use medically accepted methods of contraception\r\n* For women:\r\n** Postmenopausal for at least 1 year before the screening visit, OR\r\n** Surgically sterile, OR\r\n** Agree to practice 1 effective method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated by local labeling [e.g. United States product insert (USPI), summary of product characteristics (SmPC), etc.] after the last dose of study drug, OR\r\n**Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together\r\n* For men:\r\n** Even if surgically sterilized (i.e., status post-vasectomy), they must agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR\r\n** Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)\r\n** Agree not to donate sperm during the course of this study or 120 days after receiving their last dose of study drug
+Female and male participants of reproductive potential must agree to use adequate contraception starting from the first dose of study medication, throughout the study period, and for up to 120 days after the last dose of study medication
+Male patients must agree to use an adequate method of contraception for the duration of the study
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female subjects of childbearing potential must be willing to use an adequate method of contraception; contraception, for the course of the study through 120 days after the last dose of study medication; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception; contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects must agree to use an adequate method of contraception starting with the first dose of study medication, while on study, through 120 days after the last dose of study medication
+Patients who: a) are postmenopausal for at least 1 year before the screening visit, OR; b) are surgically sterile, OR; c) if they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR; d) agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception); male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following: e) agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR; f) agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Women of childbearing potential must agree to use an adequate method of contraception during the study and until 3 months after the last treatment; males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment; adequate methods of contraception include: total abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception; female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment; male sterilization (at least 6 months prior to screening); for female patients on the study, the vasectomized male partner should be the sole partner for that patient
+Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of last study drug
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 26 weeks after the last dose of study therapy
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together). Male participants, even if surgically sterilized (that is, status postvasectomy), who:
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together).
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects must agree to practice contraception
+Male participants must agree to use an adequate method of contraception during sexual contact with females of childbearing potential starting with the first dose of study drug through 180 days after the last dose of study drug
+Male subjects must agree to practice contraception
+Male subjects must agree to practice contraception
+Male subjects must agree to practice contraception.
+Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
+Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Willing to follow strict birth control measures as suggested below\r\n* Female patients: if they are of childbearing potential (except if postmenopausal for at least 1 year before the screening visit, OR are surgically sterile), agree to one of the following:\r\n** Practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Willing to follow strict birth control measures as suggested by the study\r\n* Female patients: If they are of childbearing potential, must agree to one of the following:\r\n** Practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception)
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy; abstinence is considered an acceptable method of contraception
+Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of the study therapy
+Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential:\r\n* Agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, OR\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)
+Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, OR\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)
+Male subjects should agree to use an adequate method of contraception during the course of the study.
+Male patients with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 6 months after the last dose of study therapy
+Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception. Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy; abstinence is considered an adequate contraception method
+Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication; note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy; note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+true sexual abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of the trial, and withdrawal are not acceptable methods of contraception.
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male participants must agree to use an adequate method of contraception starting with the first dose of radiation therapy through 120 days after the last dose of study therapy
+Male patients must agree to use an adequate method of contraception starting with the first dose of NeoVax through 4 weeks after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Willing to follow strict birth control measures as suggested by the study\r\n* Female patients: If they are of childbearing potential, must agree to one of the following:\r\n** Practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Persons of childbearing potential must be willing to use an adequate method of birth control for the course of the study through 120 days after the last dose of study medication\r\n* NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred method of contraception for the patient
+Persons able to father a child must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred method of contraception for the patient
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects must agree to use an adequate method of contraception starting with the first dose of MK-3475 through 120 days after the last dose of MK-3475
+Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (i.e., status post vasectomy), have to either: \r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study treatment, OR \r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Female patients have to fulfill one of the following: \r\n* Be postmenopausal for at least 1 year before the screening visit, OR\r\n* Be surgically sterile, OR \r\n* If of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study treatment\r\n* Patients who are using oral contraceptives as a method of contraception, and are sexually active, should use another effective contraceptive method, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male subjects must agree to the use of male contraception during the treatment period and for at least 180 days after the last dose of any study drug
+Male subjects must agree to the use of male contraception during the treatment period and for at least 180 days after the last dose of any study drug
+Female participants of childbearing potential must be willing to use adequate contraception for the course of the study starting with the first dose of study medication through 180 days after the last dose of SOC therapy or 120 days after the last pembrolizumab dose
+Male participants must agree to use adequate contraception for the course of the study starting with the first dose of study medication through 180 days after the last dose of SOC therapy or 120 days after the last pembrolizumab dose
+Women of childbearing potential and male participants must agree to use adequate contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male participants of childbearing potential must agree to use adequate contraception from the first dose of study medication, continuing throughout the study, and for up to 28 days after the last dose of lenalidomide (or 120 days after the last dose of pembrolizumab).
+Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug through 120 days after the last dose of study drug.
+Male participants of childbearing potential should agree to use an adequate method of contraception starting with the first dose of study medication through 120 days after the last dose of study medication
+Male participants of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of pembrolizumab or 180 days after chemotherapy treatment.
+Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are NOT acceptable methods of contraception
+Agree to practice true abstinence when this is line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.). Male participants, even if surgically sterilized (ie, status post vasectomy), who:
+Agree to practice true abstinence when this is line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
+Male participants of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug.
+If male with a female partner(s) of child-bearing potential, must agree to use adequate contraception starting with the first dose of study medication through 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agents.
+Remain abstinent or use a condom as defined in Section 8.3.8.4.2, starting at the planned first dose of IP until 30 days following the last dose of IP. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.
+Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug through 120 days after the last dose of study drug.
+has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months). True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.
+Refrain from semen or sperm donation while taking IP and for at least 90 days after the last dose of IP. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.
+Male or female participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 180 days after the last dose of study drug
+Male subjects must agree to use one of the methods of contraception specified. This method must be used from the time of the first dose of study medication until least 16 weeks after the last dose of study medication. In addition, male subjects whose partners are or become pregnant while on study medication must continue to use condoms for 7 days after stopping study medications.
+Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy \r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects should agree to use condoms starting with the first dose of study therapy through 30 days after the last dose of study therapy if sexually active with a female of childbearing potential
+Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
+Male subjects must: a. Practice true abstinence* or agree to the use of at least two physician-approved contraceptive methods throughout the course of the study and should avoid fathering a child during the course of the study for at least 3 months following the last dose of IP. * True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the patient. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].
+Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 120 days after the last dose of study therapy and for up to 180 days after the last dose of chemotherapeutic agents or tyrosine kinase inhibitors
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.). Male participants, even if surgically sterilized (ie, status postvasectomy), who:
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.).
+Is willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug (male and female participants of childbearing potential)
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together). Male participants, even if surgically sterilized (that is, status postvasectomy), who:
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together).
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study drug
+Female patients who: \r\n* Are postmenopausal for at least 1 year before the screening visit, OR \r\n* Are surgically sterile, OR \r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND \r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following: \r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR \r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Subject agrees to use adequate contraception during the study period and for 12 weeks after last dose of study therapy
+Male: use and adequate method of contraception with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Female subjects of childbearing potential (FOCBP) must be willing to use an adequate method of contraception; contraception must be used for the course of the study through 120 days after the last dose of study medication\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception; contraception must be used starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: male subjects will be considered to be of non-reproductive potential if they have azoospermia (whether due to having had a vasectomy or due to an underlying medical condition)\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male patients must agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy.
+Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy during the entire study treatment period and through 154 days after the last dose of lenalidomide (Revlimid) or agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Men who are sexually active with women who are of childbearing potential must adhere to contraception for a period of 5 half-lives plus 90 days for a total of 7 months after their last dose of nivolumab
+Male subjects of childbearing potential must agree to use an adequate method of contraception or abstain from heterosexual activity, starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female and male participants of reproductive potential must agree to use adequate contraception starting from the first dose of trial treatment through 90 days after the last dose of study medication
+Female patients who: \r\n* Are postmenopausal for at least 24 months before the screening visit, OR\r\n* Are surgically sterile, OR \r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (i.e., status post-vasectomy), who: \r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male participants must agree to use adequate contraception starting with the first dose through 120 days after the last dose of study medication
+Male participants must practice true abstinence* (which must be reviewed on a monthly basis) or agree to the use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 3 months following investigational product discontinuation (or longer if required by local requirements), even if he has undergone a successful vasectomy. * True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the participant. Note: Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.
+Male patients, even if surgically sterilized (ie, status post-vasectomy), who:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, or\r\n* Agree to completely abstain from heterosexual intercourse; periodic abstinence (calendar, ovulation, symptothermal, postovulation methods for the female partner) and withdrawal are not acceptable methods of contraception\r\n* Agree not to donate sperm during the course of this study or 120 days after receiving their last dose of study drug
+Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence or exclusively non-heterosexual activity when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice two effective contraception measures during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence or exclusively non-heterosexual activity when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male subjects must agree to practice contraception during the study
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male participants should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study medication.
+Male subjects should agree to use two methods of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Patients of childbearing or child fathering potential must use medically acceptable form(s) of birth control as stated within the pomalidomide Pregnancy Risk Minimization Plan, which includes abstinence, while being treated on this study; true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
+Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* Are of childbearing potential, \r\n** Agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male participants should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of pembrolizumab or through 180 days after the last dose of paclitaxel.
+Male participants should agree to use an adequate method of birth control starting with the first dose of study therapy through 120 days after the last dose of study medication
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male participants must agree to use an adequate method of contraception starting with the first dose of study medication through 180 days after the last dose of study medication
+Men who are not surgically sterile (vasectomy) must agree to use an acceptable method of contraception. Male subjects with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must agree to use condoms from the first dose of study drug through at least 120 days after the last dose of study drug. Total abstinence for the same study period is an acceptable alternative.
+Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of the study drug through 120 days after the last dose of the study drug
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of therapy
+Male participants must be willing to use an adequate method of contraception starting with the first dose of study medication through 120 days after the last dose of study treatment
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male participants must be willing to use an adequate method of contraception starting with the first dose of study medication through 120 days after the last dose of pembrolizumab or 180 days after the last dose of paclitaxel, docetaxel, or vinflunine
+Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after last dose of pembrolizumab or through 120-180 days after the last dose of docetaxel, methotrexate or cetuximab, acccording to local standard of care
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.)
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.) Male participants, even if surgically sterilized (ie, status postvasectomy), who:
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
+Male subjects must agree to use effective contraception or abstinence while on study and for 90 days after last dose of study drug
+Male subjects must agree to practice contraception
+Male participants of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study medication through 120 days after the last dose of study medication
+Male subjects must agree to practice contraception
+Male patients must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study therapy
+Male subjects must agree to practice contraception
+If they are of childbearing potential:\r\n* Agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug (female and male condoms should not be used together), or\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (i.e., status post vasectomy), who:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug (female and male condoms should not be used together), or\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)
+Male subjects must agree to practice effective barrier contraception during the entire study treatment period and through 30 days after last dose of study drug or practice true abstinence
+Female patients who: are postmenopausal for at least 1 year before the screening visit, OR are surgically sterile, OR if they are childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent, during study treatment and for 90 days after the last dose of study treatment, AND \r\n* Must also adhere to guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the following: agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study treatment, OR \r\n* Must also adhere to guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant
+Male participants who agree to practice effective barrier contraception or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant
+If they were of childbearing potential must have: had a negative pregnancy test with a sensitivity of at least 25 mIU/mL within 10 to 14 days and again within 24 hours prior to starting Cycle 1 of lenalidomide; either agreed to practice true abstinence, when this was in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal were not acceptable methods of contraception.) OR begun 2 reliable methods of birth control (1 highly effective method and 1 additional effective method) at the same time, at least 28 days before starting study treatment through 90 days after the last dose of study treatment; and agreed to ongoing pregnancy testing AND must have also adhered to the guidelines of the RevAssist program (US participants), RevAid program (Canadian participants), iAccess program (Australian participants), RevMate program (Japanese participants) or The Lenalidomide Pregnancy Risk Minimisation Plan as outlined in the Study Manual (all other participants who were not using commercial supplies). Male patients, even if surgically sterilized (ie, status postvasectomy), who:
+Agreed to practice true abstinence, when this was in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal were not acceptable methods of contraception.) OR
+Female and male subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male participants of childbearing potential must agree to use an adequate method of contraception (e.g. abstinence, vasectomy, male condom, etc.) starting with the first dose of study treatment through 120 days after the last dose of study treatment and up to 180 days after last dose of cisplatin, and refrain from donating sperm during this period
+Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Female and male participants of childbearing potential must be willing to use an adequate method of contraception, starting with the first dose of study treatment through 120 days after the last dose of study treatment and up to 180 days after last dose of chemotherapeutic agents
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR \r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception); if patient is female and of childbearing potential, she must have a negative serum beta human chorionic gonadotropin (3-HCG) test within 14 days prior to registration and consent to ongoing pregnancy testing during the course of the study
+Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following: \r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male patients agree to use an adequate method of contraception for the duration of the study
+Male patients agree to use an adequate method of contraception for the duration of the study
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female and male participants of reproductive potential must agree to use adequate contraception during the course of the study through 120 days after study the last dose of study therapy
+Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication
+Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (i.e., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.
+Females of childbearing potential and male participants must agree to use adequate contraception starting with the first dose of trial treatment through 90 days after the last dose of study medication
+Female patients must be:\r\n* Postmenopausal for at least 1 year before the screening visit, OR\r\n* Surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, or agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Women of childbearing potential must agree to use an adequate method of contraception during the study and until 3 months after the last treatment; males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment; adequate methods of contraception include: total abstinence when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception; female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment male sterilization (at least 6 months prior to screening)
+Female patients who: are postmenopausal for at least 1 year, OR are surgically sterile, OR if they are of childbearing potential, agree to practice 2 effective methods of contraception, from the time of signing the informed consent through 90 days after the last dose of study drug, OR agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception;) male patients, even if surgically sterilized, must agree to one of the following: agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject
+Male subjects must practice true abstinence* or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following IP discontinuation, even if he has undergone a successful vasectomy. * True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Note: Periodic abstinence (e.g, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.) Male participants, even if surgically sterilized (ie, status postvasectomy), who:
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.) Male participants, even if surgically sterilized (ie, status postvasectomy), who:
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
+Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR \r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male patients must agree to use an adequate method of contraception.
+Total abstinence (if this is the usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. (Subject must agree to use contraception should they become sexually active while on the study.)
+If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant (periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception).
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant (periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception).
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.)
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
+Male patients who agree to practice effective barrier contraception through 90 after the last dose of study drug or agree to practice true abstinence
+Male subjects must agree to practice contraception
+Male subjects must agree to use medically accepted form of contraception during the study period. Abstinence is an acceptable method of contraception.
+Male patient agrees to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
+Male subjects must agree to practice contraception
+Female subjects of childbearing potential must be willing to use an adequate method of contraception as outlined for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception as outlined starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+For women:\r\n* Postmenopausal for at least 1 year before the screening visit, OR\r\n* Surgically sterile, OR - If they are of childbearing potential, agree to practice 1 effective methods of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated by local labeling [e.g. United States product insert (USPI), summary of product characteristics (SmPC), etc;]) after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)
+For men, even if surgically sterilized (i.e., status post-vasectomy), they must:\r\n* Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together);\r\n* Agree not to donate sperm during the course of this study or 120 days after receiving their last dose of study drug
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy; NOTE: abstinence is acceptable if this is the established and preferred contraception for the subject
+Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before to study entry and for the duration of study participation; female patients of childbearing potential must have a negative urine or serum pregnancy test within 72 hours before receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; female patients of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient; male patients of reproductive potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception before the study, for the duration of study participation, and 4 months after completion of MK-3475 (pembrolizumab) and interferon-gamma administration
+Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.) Male participant, even if surgically sterilized (that is, status postvasectomy), who:
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Women of child bearing potential must have a negative serum or urine pregnancy test within 7 days of registration and must agree to:\r\n* Practice 1 highly effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the informed consent through 120 days (or longer, as mandated by local labeling [e.g., United Surgical Partners International (USPI), Summary of Product Characteristics (SmPC), etc.;]) after the last dose of study drug, OR\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient; NOTE: Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together
+Male patients, even if surgically sterilized (i.e., status postvasectomy) must agree to:\r\n* Practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR\r\n* Practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient;  NOTE: Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together\r\n* Not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug
+Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence and withdrawal are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (i.e. status post-vasectomy) must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence and withdrawal are not acceptable methods of contraception)
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female subjects of childbearing potential must be willing to use adequate methods of contraception for the course of the study through 120 days after the last dose of study medication; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year\r\n* NOTE: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* NOTE: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects agree to use an adequate method of contraception starting with the first dose of study therapy through 31 weeks after the last dose of study therapy
+Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy.
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects: unwilling or unable to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
+Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
+Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participants. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.) Male participants, even if surgically sterilized (that is, status postvasectomy), who:
+Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participants. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
+Male participants of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days (or longer as specified by local institutional guidelines) after the last dose of study drug.
+Female subjects of childbearing potential must be willing to use adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
+Female patients of childbearing potential must be willing to use adequate method of contraception - contraception, for the course of the study through 120 days after the last dose of study medication; patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
+Male patients must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy