Women who are not postmenopausal or have not undergone a hysterectomy must have documented negative pregnancy test within  days prior to randomization\r\n* Postmenopausal is defined as one or more of the following: \r\n** Age >=  years (yrs)\r\n** Age <  and amenorrheic for  year or more in the absence of chemotherapy and/or hormonal treatment\r\n** Follicle-stimulating hormone (FSH) and plasma estradiol levels in the post menopausal range for women under \r\n** Radiation-induced oophorectomy with last menses >  year ago\r\n** Bilateral oophorectomy\r\n* Female patients of childbearing potential who are sexually active must agree, with their partners, to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for at least  month after the last dose of study drug, or they must totally/truly abstain from any form of sexual intercourse; male patients must agree, with their partners who are sexually active and of childbearing potential, to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for  months after last dose of study drug, or they must totally/truly abstain from any form of sexual intercourse
Male and female patients able to have children must agree to use  highly effective methods of contraception throughout the study and for at least  days after last dose of chemotherapy or at least  days after last dose of avelumab, whichever is longer
Patient and his/her partner agree to use adequate contraception after providing written informed consent through  months after the last dose of TVB-, as follows:\r\n* For women: Compliant with a medically-approved contraceptive regimen during and for  months after the treatment period or documented to be surgically sterile or postmenopausal\r\n* For men: Compliant with a medically-approved contraceptive regimen during and for  months after the treatment period or documented to be surgically sterile; men whose sexual partners are of child-bearing potential must agree to use  methods of contraception prior to study entry, during the study, and for  months after the treatment period
Effective contraception during the study period and for  months after the last study treatment administration (male and female patient)
If male with a female partner(s) of child-bearing potential, must agree to use an adequate method of contraception starting with the first dose of study drug through  days after the last dose of study drug. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.
Male patients are eligible to enter and participate in the study if they are vasectomized or agree to use of contraception during the study treatment period and for at least  days after the last dose investigational product.
Male participants must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception and use a condom throughout the study period and for  days after study drug discontinuation)
Women of childbearing potential and men who are able to father a child, must agree to use an effective contraception method during study and for  months following study drug administration
Agreement to use contraception during the study and for  days after the last dose of study drugs if sexually active and able to bear or beget children.
Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for  months following the last dose of study drug
Subjects of fertile potential who engage in heterosexual intercourse with partners of childbearing potential must agree to use highly effective contraception while enrolled in the study and for at least  months following the last dose of study drug
do not agree to use a highly effective method of contraception for the entire study period and for  days after study drug discontinuation, ie:
Subjects who may become pregnant or who are sexually active with a partner who could become pregnant are to use an effective form of barrier contraception during the study and for at least  days for female patients and  days for male patients after administration of study drug; and
Female participants of childbearing potential must be willing to use a highly effective method of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study drug through  days after last dose of study drug. Male participants of reproductive potential must agree to use a highly effective method of contraception during sexual contact with females of childbearing potential starting with the first dose of study drug through  days after the last dose of study drug.
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  days after the last dose of study drug. Total abstinence for the same study period is an acceptable alternative.
Agree to use effective contraception until  days following the last dose of investigational product and have a male partner who uses a condom or
For male patients who are sexually active and who are partners of premenopausal women: agreement to use two forms of contraception as in criterion  above during the treatment period and for at least  months after the last dose of study drug.
If male with a female partner(s) of child-bearing potential, must agree to use an adequate method of contraception starting with the first dose of study drug through  days after the last dose of study drug. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.
Agreement to use contraception during the study and for  days after the last dose of study drugs if sexually active and able to bear or beget children.
Women of child-bearing potential (WoCBP) may be included only if acceptable contraception is in place for two weeks before study entry, for the duration of the treatment with the study drug, and for  months after the last dose of AZD; male patients who are involved in the study must agree to avoid procreative and unprotected sex (i.e., by using acceptable forms of contraception) and must not donate sperm during the study and for  months after the last dose of AZD; where the female partner is pregnant or not using effective birth control, men should be advised to abstain while in the study and for  months after the last dose of AZD; female partners, who are of child-bearing potential, of men participating in clinical studies of AZD will also be required to use effective contraceptive measures while their partner is on study drug and for  months thereafter; male patients will be advised to arrange for the freezing of sperm samples prior to the start of the study should they wish to father children while on AZD or during the  months after stopping AZD
Women of childbearing potential and their partners, who are sexually active, must agree to the use of  highly effective forms of contraception in combination or must totally/truly abstain from any form of sexual intercourse. This should be started from the signing of the informed consent, throughout their participation in the study and for at least  month after the last dose of olaparib
Not of childbearing potential or who agree to use a highly effective method of contraception during the study beginning within  weeks prior to the first dose and continuing until  months after the last dose of study drug.
Men with a female partner of childbearing potential must have either had a prior vasectomy agree to use effective contraception as described in the full protocol for at least  days prior to administration of the first dose of study treatment, during the study, and for  days following the last dose of osimertinib
For male subjects who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception, willingness to use an effective method of contraception from the start of study therapy until ? months after the last dose of cirmtuzumab and ? month after the last dose of ibrutinib, whichever is later and to refrain from sperm donation from the start of study therapy until ? months after administration of the final dose of either of the study drugs. Note: A male subject is considered able to father a child unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy.
Male and female patients able to have children must agree to use  highly effective methods of contraception throughout the study and for at least  days after last dose
Males with female partners of child-bearing potential must agree to use a barrier contraception (e.g., condom with spermicidal foam/gel/film/cream/suppository) throughout the duration of the study until  months following the last dose of study drug; in addition to their female partner using either an intrauterine device or hormonal contraception and continuing until  months following the last dose of study drug. Male patients should not donate sperm until  months following the last dose of study drug.
Agreement to use acceptable methods of contraception during the study and for at least  days after the last dose of APX if sexually active and able to bear or beget children.
Not of childbearing potential or who agree to use a highly effective method of contraception during the study beginning within  weeks prior to the first dose and continuing until  months after the last dose of study drug.
agree to use a highly effective method of contraception during the study and for  months following the last dose of study treatment.
The effects of INCB, dabrafenib, and trametinib on the developing human fetus are unknown. For this reason, women of child-bearing potential must have a negative serum pregnancy test within  days prior to registration and agree to use effective contraception (barrier method of birth control, or abstinence; hormonal contraception is not allowed due to drug-drug interactions which can render hormonal contraceptives ineffective) from  days prior to registration, throughout the treatment period, and for  months after the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Based on studies in animals, it is also known that dabrafenib may cause damage to the tissue that makes sperm. This may cause sperm to be abnormal in shape and size and could lead to infertility, which may be irreversible. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception. Additionally, male subjects (including those who are vasectomized) whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and for  months following completion of therapy.
Men with a female partner of childbearing potential must agree to use highly effective methods of contraception or any contraceptive method with a failure rate of less than % per year during the study and for  months following completion of study treatment
All sexually active subjects agree to use barrier contraception (i.e., condoms) while receiving study treatment and for  days following their last dose of study treatment; female subjects of child-bearing potential and male subjects whose sexual partners are women of childbearing potential (WOCBP) agree to use barrier contraception and a second form of contraception while receiving study treatment and for  months following their last dose of study treatment; 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
Do not agree to use a highly effective method of contraception for the entire study period and for  months after study drug discontinuation, ie:
Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period or for  months after study drug discontinuation). No sperm donation is allowed during the study period or for  months after study drug discontinuation.
Pregnancies\r\n* Females: females may not take part in this study if pregnant or breast-feeding for  months after last dose of study drug; women of child-bearing potential (WOBCP) will be asked to take a pregnancy test prior to starting study medication\r\n* Males: Male subjects should avoid fathering a child while receiving study medication and for  months after the last dose of study medication; males must agree to complete abstinence from heterosexual contact or use a condom during sexual contact with a female of child bearing potential while receiving study medication and within  months after last dose of study medication; if a female partner of a male subject taking investigational product becomes pregnant, the male subject taking the product should notify the principal investigator, and the pregnant female partner should be advised to call their healthcare provider immediately\r\n* Subjects (both males and female) should practice effective contraception during study and for  months after the last dose of study medication
To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must use a condom during sexual activity while on study drug and for  months following the last dose of study drug. If the subject is engaged in sexual activity with a woman of childbearing potential, a condom is required along with another effective contraceptive method consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies and their partners. Donation of sperm is not allowed while on study drug and for  months following the last dose of study drug.
Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period or for  months after study drug discontinuation)
Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for at least  months after the last dose of huJCAR
Male participants and their partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination, throughout the period of taking study treatment and for  months after last dose of study drug to prevent pregnancy in a partner
Agreement to use highly effective forms of contraception during the study and  days after the last dose of acalabrutinib,  months after the last dose of bendamustine, or  months after the last dose of rituximab, whichever is longest .
Subjects of reproductive potential must agree to avoid becoming pregnant or impregnating a partner, respectively, while receiving study drug and for  days after the last dose of study drug by complying with one of the following: () practice abstinence from heterosexual activity; OR () use (or have their partner use) acceptable contraception during heterosexual activity.
Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from the administration of the first dose of study treatment until  months after the last dose of study treatment to allow for clearance of any altered sperm.
Male and female patients of reproductive potential must agree to follow accepted birth control measures throughout the study period and for  days after the last dose of either study drug for females and  months after the last dose of study drug for males
A WCBP and a male patient with a partner who is a WCBP must agree to use a medically accepted method for preventing pregnancy for the duration of study treatment and for at least  months following completion of study treatment
Men must agree to the use of male contraception during the study treatment period and for at least  weeks after the last dose of study drug
Women of childbearing potential (defined as not post-menopausal for  months or no previous surgical sterilization) and fertile men must agree to use two highly effective forms of contraception while they are receiving study treatment and for  days after last dose of study drug; male subjects must agree to refrain from sperm donation during the study and for  days after the last dose of study drugs
Men must agree to not conceive during the treatment and to use effective contraception during the treatment period (including periods of dose reduction or temporary suspension) and for a further  months after the end of treatment if their partner is of childbearing potential
Male patients must agree to use condoms during intercourse throughout study drug therapy and the following  months.
A woman of child-bearing potential (WCBP) and a male patient with partner who is a WCBP must agree to use a medically accepted method for preventing pregnancy for the duration of study treatment and for  months following completion of study treatment
Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for  weeks following the last dose of study drug
Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and a period of  weeks after the last dose of investigational drug
A WCBP and a male patient with a partner who is a WCBP must agree to use a medically accepted method for preventing pregnancy for the duration of study treatment and for  months following completion of study treatment
Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for  days following the last dose of study drug
Men who are not surgically or medically sterile must agree to use an acceptable method of contraception. Male patients with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must agree to use condoms at least one month after the last dose of study drug. Total abstinence for the same study period is an acceptable alternative
Female subjects of childbearing potential and non-sterile males must practice at least one of the following methods of birth control with partner(s) throughout the study and for  days after discontinuing study drug: total abstinence from sexual intercourse, double-barrier contraception, IUD or hormonal contraceptive initiated at least  months prior to first dose of study drug.
Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for  days following the last dose of study drug
Males and their female partner(s) of child-bearing potential must use  forms of effective contraception (see Inclusion  plus condom or vasectomy for males) from the last menstrual period of the female partner during the study treatment and for  months after the final dose of study treatment.
Not of childbearing potential or who agree to use a highly effective method of contraception during the study beginning within  weeks prior to the first dose and continuing until  months after the last dose of study drug.
Do not agree to use a highly effective method of contraception for the entire study period and for  months after study drug discontinuation, ie:
Males who have not had a successful vasectomy (confirmed azoospermia) or if they and their female partners do not meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period or for  days after study drug discontinuation). No sperm donation is allowed during the study period or for  days after study drug discontinuation.
Male participant who is not surgically sterile and is sexually active with female partner of childbearing potential must agree to practice  effective contraceptive methods for study duration, starting at Screening through  days after stopping study drug
Male subjects agree to ensure that they or their female partner(s) use adequate contraception during the study and for at least  weeks (or longer as per local requirement) after the subject receives their last dose of study treatment.
Males not naturally or surgically sterile, who have a female partner of childbearing potential, must agree to use two reliable methods of contraception from screening and up to  days after discontinuation of study treatment
Male subjects must agree to contraceptive use during the study period ( months) and non-menopausal female subjects must agree to contraception for the remainder of their childbearing years
Male patients and their partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for  months after last dose of study drug(s) to prevent pregnancy in a partner.
Is not pregnant, and if not postmenopausal or a surgically sterile male or female, is willing to use a highly effective contraceptive method upon enrollment, during the course of the study, and for  months following the last dose of investigational drug
Not of childbearing potential or who agree to use a highly effective method of contraception during the study beginning within  weeks prior to the first dose and continuing until  months after the last dose of study drug.
Male patients and their partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for  months after last dose of study drug(s) to prevent pregnancy in a partner
Male patients and their partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination, throughout the period of taking study treatment and for  months after last dose of study drug(s) to prevent pregnancy in a partner.
Male patients must agree to use effective contraception during the study and for a period of at least  months following the last administration of study drugs, even if they have been surgically sterilized
Male subject with a female partner of childbearing potential or pregnant must agree to use two acceptable methods of contraception from time of first dose of study treatment until  months after the last dose of study treatments
Women of childbearing potential must have a negative serum pregnancy test within  hours prior to the first dose of BAL; women of childbearing potential must agree to use highly-effective contraceptive methods for the duration of study participation and for an additional  days after the last dose of study drug; highly-effective contraceptive methods include male or female sterilization (bilateral tubal occlusion or vasectomy); intrauterine device (IUD); combined (estrogen- and progesterone-containing) hormonal contraception (oral, vaginal ring or transdermal patch) with an ethinylestradiol dose of at least  ug, plus use of male condoms (preferably with spermicides), female condoms, a female diaphragm or a cervical cap; or total sexual abstinence; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; male patients must agree not to donate sperm from the first dose of study drug until  days after the last dose of study drug; male patients, without a vasectomy and with a partner of childbearing potential, must agree to use condoms during the study and for at least  days after the last dose of study drug; the patient should be instructed that their female partner should use another form of contraception for the duration of the study and continue this use for at least  days after the last dose of study drug
A WCBP and a male patient with a partner who is a WCBP must agree to use a medically accepted method for preventing pregnancy for the duration of study treatment and for  months following completion of study treatment
Male patients and their partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination, throughout the period of taking study treatment and for  months after last dose of study drug(s) to prevent pregnancy in a partner
Women of childbearing potential and males with partners of childbearing potential must agree to the use of barrier methods of contraception, hormonal contraceptives, or to abstain from heterosexual activity for the duration of study treatment and for  months after the last dose of study drug
It is important patients understand the need to use birth control while on this study; female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening (<  days prior to first dose), male patients with partners of childbearing potential must agree to use effective contraception during the study period and a period of  months after the last dose of study drug; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose
A male subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study (and for up to  weeks after the last dose of study drug) to minimize the risk of pregnancy; if the partner is pregnant or breastfeeding, the subject must use a condom
Women of childbearing potential (i.e. patients whose reproductive organs remain in place and who have not passed menopause) and men must agree to use a highly effective method of contraception (e.g. hormonal, intrauterine device or; abstinence*) prior to study entry, during the study participation, and for six months after the last dose of the drug; women of child-bearing potential must have a negative pregnancy test within  days prior to randomization, cannot be breast-feeding, and must agree to use a highly effective form of contraception throughout the treatment period and for  months after the last dose of study treatment; 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; * abstinence is only acceptable when this is in line with the preferred and usual lifestyle of the patient
Agree to use contraception from screening, through the study, and for at least  months after the last dose of nivolumab as follows: for women of childbearing potential agree to use highly effective contraceptive methods; for males, agree to use a condom with sexual partner.
If male and sexually active with a FCBP, must agree to use highly effective contraception such as latex condom or is sterile (e.g. following a surgical procedure) during the dosing period and for three months after last study treatment, or if receiving pembrolizumab, four months after last treatment
Male subjects with a female partner of childbearing potential must either commit to true abstinence* or agree to the use of a physician-approved contraceptive method throughout the course of the study and avoid fathering a child during the course of the study and for  months following the last dose of the IP (Investigational Product).
Women of childbearing potential and fertile men must agree to use adequate contraception when sexually active. This applies from the time period between signing of the informed consent until at least  months after the last administration of the last study drug. Male patients with a female partner of childbearing potential must use a condom and ensure that an additional form of contraception is also used during treatment and until  months after last study drug administration.
Females of childbearing potential (not surgically sterile or less than  months post-menopausal) must be able and willing to use a highly effective form of pregnancy prevention from the time of screening, during the study and  days after last dose of study regimen. Males with a partner of childbearing potential must use condoms with spermicide from the date of screening to  days after their last dose of study regimen
Male participants must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period and for  months after discontinuation of chemotherapy and for  weeks after Test Article (amatuximab or placebo) discontinuation (whichever is later). No sperm donation is allowed during the study period and for  days after Test Article discontinuation.
Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from the administration of the first dose of study treatment until  months after the last dose of study treatment to allow for clearance of any altered sperm.
For female participants of childbearing potential, agreement (by both participant and partner) to use an effective form of contraception for the duration of the study and for  months after last dose of study treatment
Male subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period and for  days after study drug discontinuation). No sperm donation is allowed during the study period and for  days after study drug discontinuation.
A male subject must agree to use and to have their female partners of childbearing potential to use a highly effective contraception (i.e., methods with a failure rate of less than  % per year) as detailed in Appendix VII of this protocol from the first dose of study treatment, during the treatment period and for at least  months after the last dose of study treatment and refrain from donating sperm during this period. Male subjects should always use a barrier method such as condom concomitantly.
Women of childbearing potential (WOCBP) and men must agree to use effective contraceptive methods from Screening throughout the study treatment period and until at least  days after the last dose of IMO-,  months after the last dose of ipilimumab or at least  months after the last dose of pembrolizumab.
Patients of childbearing potential are permitted in the study so long as they consent to avoid getting their partner pregnant or becoming pregnant, respectively, by using a reliable method(s) of contraception during and for  months following the last dose of the study drugs
Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for  days following the last dose of study drug
Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for  weeks after the last dose of nivolumab
It is important patients understand the need to use birth control while on this study; female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening (<  days prior to first dose), male patients with partners of childbearing potential must agree to use effective contraception during the study period and a period of  months after the last dose of study drug; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose
Men who are not surgically or medically sterile 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 date of the first dose of study drug through at least one month after the last dose of study drug. Total abstinence for the same study period is an acceptable alternative.
A male subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study and for up to  weeks after the last dose of study drug to minimize the risk of pregnancy; if the partner is pregnant or breastfeeding, the subject must use a condom
Male subjects with female partner of childbearing potential must agree to the use of a physician-approved contraceptive method throughout the course of the study and for a minimum of  weeks following the discontinuation of study treatment
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  days after the last dose of study drug. Total abstinence for the same study period is an acceptable alternative.
Male and female subjects who are not surgically sterile or post-menopausal must agree to use reliable methods of birth control for the duration of the study and for  days after the last dose of study drug administration; male partners of female subjects should use condoms for the duration of the study, and for  days after the last dose of study drug administration
Agreement to use contraception during the study and for  days after the last dose of study drugs if sexually active and able to bear or beget children.
Men must agree to use adequate contraception beginning at the signing of the informed consent (ICF) until at least  months after the last dose of study drug; men who are sexually active must agree to use condoms and their female partners of reproductive potential must agree to use a highly effective contraceptive method during and for  months after completing treatment
Agreement to use contraception during the study and for  days after the last dose of study drugs if sexually active and able to bear or beget children.
Negative serum pregnancy test done =<  days prior to registration/randomization, for women of childbearing potential only\r\n* Note:\r\n** Females: adequate contraception must be used by both patient and partner while receiving study drug and for  weeks after the last dose of study drug\r\n** Males: adequate contraception must be used by both patient and partner while receiving study drug; men who have a partner of childbearing age should also avoid fathering a child for  months after the last dose of study drug
Agreement to use contraception during the study and for  days after the last dose of study drugs if sexually active and able to bear or beget children.
Male subjects must agree to use effective contraception or abstinence while on study and for  days after last dose of study drug
Agreement to use contraception during the study and for  days after the last dose of study drug if sexually active and able to bear children.
Male patients of childbearing potential must use a condom during sexual intercourse and shall not father a child during the study and for  months after the last dose of study medication.
Post-menarche female subjects and male subjects must be asked to use appropriate contraception for both the male and female for the duration of the study. Subjects must agree to use two forms of contraception or agree to refrain from intercourse for the duration of the study. Females must not be pregnant at the start of the study, and a serum human chorionic gonadotropin (HCG) pregnancy test must be negative before entry into the study.
Male subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period and for  days after study drug discontinuation). No sperm donation is allowed during the study period and for  days after study drug discontinuation.
Women of childbearing potential and men must agree to use effective contraceptive methods while on study and for at least twelve weeks after the last dose of study drug.
Agreed to practice effective barrier contraception during the entire study treatment period and  days after the last dose of study treatment if their partner was of childbearing potential, even if they had a successful vasectomy, AND
Male subjects with a female partner of childbearing potential must be willing to continue practicing the same acceptable method of contraception as used in the parent study during the rollover study and for at least  weeks after the last dose of GSK.
Female subjects of childbearing potential, as defined in the parent study, must be willing to continue practicing the same acceptable method of contraception as used in the parent study during the rollover study and for at least  weeks after the last dose of GSK.
Female subjects of childbearing potential, as defined in the parent study, must be willing to continue practicing the same acceptable method of contraception as used in the parent study during the rollover study and for at least  months after the last dose of GSK.
For female participants of childbearing potential and male participants with partners of childbearing potential, agreement (by participant and/or partner) to use highly effective forms of contraception and to continue its use for the duration of the study and for  months after last dose of study treatment (for females) and  months after last dose of study treatment (for males)
Women of childbearing potential and men must agree to use effective contraceptive methods from Screening throughout the study treatment period and until at least  weeks after the last dose of study drug.
A male subject who is sexually active with a woman of childbearing potential is eligible to enter the study if he agrees to use effective contraception throughout the study and for  months after the last dose of study agent.
For both male and female patients, effective methods of contraception must be used throughout the study and for  months following the last dose of study treatment
Men or WOCBP, to include female partners of heterosexual or bisexual patients, must agree to use an effective method of contraception during the study and for up to three months following discontinuation of study drug
Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for  days following the last study drug administration
Male subjects must be surgically sterile or must agree to use highly effective physician-approved contraception from Screening to  days following the last study drug administration
Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception as described in protocol from the administration of the first dose of study treatment until  months after the last dose of study treatment to allow for clearance of any altered sperm.
Agreement to use acceptable methods of contraception during the study and for ?  days after the last dose of PNT if sexually active and able to bear or beget children.
Lactating or pregnant or will not agree to use contraception during the study and for  days after the last dose of study drug if sexually active and able to bear children
Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from time of randomization until  weeks after the last dose of study treatment
Men with a female partner of childbearing potential must have either had a prior bilateral vasectomy with resultant azoospermia, bilateral orchiectomy, or must agree to use one of the contraception methods listed in protocol from the time of the first dose of study medication until at least  weeks ( days) after the last dose of study treatment due to the long elimination phase of study drug.
Males not naturally or surgically sterile, who have a female partner of childbearing potential, must agree to use two reliable methods of contraception from screening and up to  days after discontinuation of study treatment.
Effective contraception during the study period and for  months after the last study treatment administration (male and female patient)
For women of childbearing potential and men, agree to use effective contraceptive methods from screening, through the study, and for at least  weeks after the last dose of study drug.
Males who have had a successful vasectomy (confirmed azoospermia) or they and their female partners meet the criteria above (that is, not of childbearing potential or practicing highly effective contraception throughout the study period or for  days after study drug discontinuation). No sperm donation is allowed during the study period or for  days after study drug discontinuation.
For female participants of childbearing potential, agreement to use highly effective form(s) of contraception for the duration of the study and for at least  months after last dose of study treatment
Male subjects with pregnant or lactating partners or partners who plan to become pregnant while on study or within  months after the planned administration of the last dose of study drug
Male subjects with female partner of childbearing potential must agree to the use of a physician-approved contraceptive method throughout the course of the study and for  months after the last dose of the investigational product
Pregnant or breastfeeding females and male or female patients who refuse to use adequate contraception during the study and for  weeks after the last dose of study treatment
Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for  days following the last dose of study drug
Female patients of childbearing potential and sexually active male patients must agree to use an acceptable form of contraception for heterosexual activity (ie, oral contraceptives, double barrier methods, hormonal injectable, transdermal, or implanted contraceptives, tubal ligation, or vasectomy of their sexual partner(s) for >  days before Screening, during the study, and for  days after the last dose of study drug. Men should not donate semen during the study and for  days after the last dose of study drug.
Males and their female partner(s) of child-bearing potential must use  forms of effective contraception (see Inclusion  plus condom or vasectomy for males) from the last menstrual period of the female partner during the study treatment and agree to continue use for  months after the final dose of study treatment.
Patients, both male and female, who are either not of childbearing potential or who agree to use a medically effective method of contraception during the study and for  months after the last dose of study drug.
Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from time of randomization until  days after the last dose of investigational product.
Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception for at least  weeks prior to administration of the first dose of study treatment and for at least  months after the last dose of chemotherapy to allow for clearance of any altered sperm.
Male subjects (including those who are vasectomized) whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and for  days following completion if therapy.
Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception for at least  weeks prior to the first dose of study treatment until  weeks after the last dose of study treatment to allow for clearance of any altered sperm
Patients, both male and female, who are either not of childbearing potential or who agree to use a medically effective method of contraception during the study and for  months after the last dose of study drug.
A male subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study and for up to  weeks after the last dose of study drug to minimize the risk of pregnancy; if the partner is pregnant or breastfeeding, the subject must use a condom
Males must agree to use condoms during sex to prevent spillage of semen for the duration of the study and for  months after the patient leaves the study
Male subject with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from time of Screening until  months after the last dose of study treatment.
Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for  days following the last study drug administration;
Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from  weeks prior to administration of the first dose of study treatment until one year after the last dose of study treatment.
Males who do not agree to use effective contraception during the study and for a period of  days following the final dose of study agent.
To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must use a condom during sexual activity while on study drug and for  months following the last dose of study drug; if the subject is engaged in sexual activity with a woman of childbearing potential, a condom is required along with another effective contraceptive method consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies and their partners; donation of sperm is not allowed while on study drug and for  months following the last dose of study drug
If female, must be:\r\n* Postmenopausal for at least  year before the screening visit; OR\r\n* Surgically sterile; OR\r\n* Agreeable to practicing  effective methods of contraception prior to study entry, for the duration of study participation, and for  days after the last dose of study treatment
If a sexually active heterosexual male, must be agreeable to practicing  effective methods of contraception prior to study entry, for the duration of study participation, and for  days after the last dose of study treatment
Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period or for  days after study drug discontinuation). No sperm donation is allowed during the study period and for  days after study drug discontinuation.
Male subjects with female partners of child bearing potential must agree to use one of the methods of contraception specified in protocol from time of first dose of study treatment until  days after the last dose of study treatment.
Woman of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for  days after the last dose of the study drug; men who are sexually active must agree to use highly effective contraception during the period of therapy and for  months after the last dose
Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from the time of first dose of study until  days after the last dose of study treatment to allow for clearance of any altered sperm
Male subjects of childbearing potential must be willing to use a condom during sexual intercourse and shall not father a child during the course of the study or will practice complete abstinence while on study
Agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study (women for  weeks and men for  weeks after the last dose of study drug)