--- a
+++ b/clusters/9knumclustersv2/clust_1060.txt
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+For women of childbearing potential only, a negative pregnancy test done =<  days prior to registration is required; a female of childbearing potential is a sexually mature female who:\r\n* Has not undergone a hysterectomy or bilateral oophorectomy; or \r\n* Has not been naturally postmenopausal for at least  consecutive months (i.e. has had menses at any time in the preceding  consecutive months)
+Participants of childbearing potential, defined as a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months), must have a pregnancy test within  days prior to enrollment and agree to use an effective form of contraception (e.g., barrier contraception, highly effective hormonal contraception)
+Not pregnant and not nursing: a female of childbearing potential is a sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months); female subject of childbearing potential should have a negative urine or serum pregnancy within  hours prior to 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 subjects of childbearing potential should be willing to use  methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through  days after the last dose of study medication
+Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity  IU/L or equivalent units of human chorionic gonadotropin [HCG]) within  days of CD; a woman of childbearing potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least  consecutive months (i.e. has had menses at any time in the preceding  consecutive months)
+Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice contraception; FCBP definition: a female of childbearing potential is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least  consecutive months
+Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at screening and =<  hours prior to day  of study treatment; if the urine pregnancy test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\r\n* A woman of childbearing potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least  consecutive months (i.e. has had menses at any time in the preceding  consecutive months).
+Female patients who are postmenopausal for at least  year before the screening visit or are surgically sterile are eligible; females of childbearing potential (as defined below) may also be eligible but must have a negative serum or urine pregnancy test with a sensitivity of at least  mIU/mL within  days of registration\r\n* A female of childbearing potential is a sexually mature female who:\r\n** Has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) OR\r\n** Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least  consecutive months (i.e., has had menses at any time during the preceding  consecutive months)
+Negative serum pregnancy test done =<  days prior to registration, for women of childbearing potential only; a serum pregnancy test will be conducted =<  hours prior to treatment start as a pre-treatment parameter; all women of reproductive potential and their partners, must agree to use adequate methods of birth control (e.g. latex condoms) throughout the study and for  days after the last dose of study drug;\r\n* A female of reproductive potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least  consecutive months (i.e. has had menses at any time in the preceding  consecutive months)
+A female of childbearing potential (FCBP) is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months)
+Women of child-bearing potential, who are biologically able to conceive and not employing two forms of highly effective contraception; two forms of highly effective contraception must be used throughout the trial and up to  weeks after the last dose of study drug (e.g. male condom with spermicide; diaphragm with spermicide; intra-uterine device); oral, implantable, or injectable contraceptives that may be affected by cytochrome P interactions are not considered effective for this study; women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least  consecutive months (i.e., who has had menses any time in the preceding  consecutive months), must have a negative serum pregnancy test =<  days prior to starting study drug
+(FCBP) is any sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy or ) has not been naturally postmenopausal (not having menstrual cycles due to cancer therapy does not rule out childbearing potential) for at least  consecutive months.
+Women of child-bearing potential, who are biologically able to conceive, and not employing two forms of highly effective contraception; highly effective contraception must be used throughout the trial and up to  weeks after the last dose of study drug (e.g. male condom with spermicidal; diaphragm with spermicide; intra-uterine device); women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least  consecutive months (i.e., who has had menses any time in the preceding  consecutive months), must have a negative serum pregnancy test ?  days prior to starting study drug
+Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not using an effective method of birth control. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least  consecutive months (i.e., who has had menses any time in the preceding  consecutive months). Women of childbearing potential must have a negative serum pregnancy testing within  days prior to the administration of drug
+Not pregnant and not nursing\r\n* Women of childbearing potential must have a negative pregnancy test done =<  days prior to registration\r\n* A female of childbearing potential is a sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least  consecutive months (i.e. has had menses at any time in the preceding  consecutive months)
+Patients must not be pregnant or breastfeeding; a pregnancy test will be obtained if the patient is a woman of child-bearing potential, defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least  consecutive months (i.e., who has had menses at any time in the preceding  consecutive months) with  pregnancy tests one at screening and second one right before\r\ndosing to document pregnancy status
+Negative serum or urine beta-human chorionic gonadotropin (HCG) in women of child-bearing potential =<  days prior to registration\r\n* A female of childbearing potential is a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least  consecutive months
+Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not using an effective method of birth control; WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least  consecutive months (i.e. who has had menses anytime in the proceeding  consecutive months); women of childbearing potential must have a negative serum pregnancy test within  hrs of receiving the first dose of study medication
+Men whose partner is a woman of child-bearing potential, (i.e. biologically able to conceive), and who is not employing two forms of highly effective contraception. Highly effective contraception (e.g. male condom with spermicide, diaphragm with spermicide, intra-uterine device) must be used by both sexes during the study and must be continued for  days after the end of study treatment. Women of child-bearing potential is defined as sexually mature women who are not surgically sterile or who have not been naturally postmenopausal for at least  consecutive months (e.g., who has had menses any time in the preceding  consecutive months).
+Women of childbearing potential must have a negative serum pregnancy test within  days prior to registration; women of non-childbearing potential are defined as those who have no uterus, ligation of the fallopian tubes, are naturally postmenopausal for at least  consecutive months or have undergone surgical removal of the ovaries
+Women who are pregnant or breast feeding or women of child bearing potential (WOCBP) not willing to use a double barrier method of contraception during the study and  months after the end of treatment; one of these methods of contraception must be a barrier method; WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least  consecutive months (i.e., who has had menses any time in the preceding  consecutive months)
+Females of childbearing potential must have a negative urine pregnancy test prior to simulation and within seven days of SABR start; a female of childbearing potential is a sexually mature woman who ) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or ) has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time during the preceding  consecutive months)
+Women of childbearing potential (a woman of child-bearing potential is a reproductively mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least  consecutive months [i.e., who has had menses at any time in the preceding  consecutive months]) and male participants must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study.
+Negative urine pregnancy test within  hours prior to the first dose of study therapy for women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally post- menopausal for at least  consecutive months (i.e., who has had menses any time in the preceding  consecutive months)
+Women of child-bearing potential, who are biologically able to conceive, and not employing two forms of highly effective contraception; highly effective contraception must be used throughout the trial and up to  months after the last dose of study drug (e.g. male condom with spermicidal; diaphragm with spermicide; intra-uterine device); women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least  consecutive months (i.e., who has had menses any time in the preceding  consecutive months), must have a negative serum pregnancy test ?  days prior to starting study drug
+Women of childbearing potential must have a negative serum pregnancy test during the Screening Period and within  hours of the first dose of ARQ . \Women of childbearing potential\ is defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least  consecutive months prior to the first dose of ARQ .
+Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not using an effective method of birth control; WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least  consecutive months (i.e., who has had menses any time in the preceding  consecutive months); women of childbearing potential must have a negative serum pregnancy test within hrs of receiving the first dose of study medication
+Patients with a negative pregnancy test (urine or serum) must be documented within  days of screening for women of childbearing potential (WOCBP); a WOCBP has not undergone a hysterectomy or who has not been naturally postmenopausal for at least  consecutive months (i.e. who has not had menses at any time in the preceding  consecutive months)
+Negative serum pregnancy test within  days prior to the first dose of study therapy for women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally post-menopausal for at least  consecutive months (i.e., who has had menses any time in the preceding  consecutive months). Sexually active WCBP and male subjects must agree to use adequate methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for  days after the completion of study treatment.
+Women of child bearing potential must have a negative serum or urine pregnancy test within  days prior to study registration and agree to use adequate birth control during study treatment; a female of childbearing potential (FCBP) is a sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months)
+Non-pregnant and non-nursing women of childbearing potential must have a negative serum or urine pregnancy test within  days of crenolanib commencement (\Women of childbearing potential\ is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding  consecutive months).
+Women of childbearing potential (those who have not undergone a hysterectomy or who have not been postmenopausal for at least  consecutive months) must agree to practice adequate contraception and to refrain from breast feeding
+Females of child bearing potential that are sexually active must agree to either practice  medically accepted highly effective methods of contraception at the same time or abstain from heterosexual intercourse from the time of signing the informed consent through  days after the last dose of study drug. See Appendix C for a list of protocolapproved highly effective methods of contraceptive combinations. \r\n Negative test for pregnancy is required for females of child-bearing potential; A female of child bearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: . has not undergone a hysterectomy or bilateral oophorectomy; or . has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months or  days). \r\n Conception while on treatment must be avoided
+Patients with a negative pregnancy test (urine or serum) must be documented within  days of screening for women of childbearing potential (WOCBP); a WOCBP has not undergone a hysterectomy or who has not been naturally postmenopausal for at least  consecutive months (i.e. who has not had menses at any time in the preceding  consecutive months)
+Pregnancy testing will be performed within  days of screening for women of childbearing potential (WOCBP); a WOCBP has not undergone a hysterectomy or who has not been naturally postmenopausal for at least  consecutive months (i.e. who has not had menses at any time in the preceding  consecutive months)
+Female subjects of child-bearing potential must have a negative serum or urine pregnancy test within  hours prior to administration of the first dose of study drug. \Women of childbearing potential\ is defined as sexually mature women who have not undergone hysterectomy and/or bilateral oophorectomy, or who have not been naturally postmenopausal for at least  consecutive months prior to administration of the first dose of the study drug.
+Females of childbearing potential should have a negative serum beta-human chorionic gonadotropin (HCG) test within  hours of beginning DLI and/or DUK-CPG- unless contraception is used after initial testing; a female of childbearing potential (FCBP) is a sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months)
+Females of childbearing potential should have a negative serum beta-HCG test within  hours of beginning apheresis unless contraception is used after initial testing; a female of childbearing potential (FCBP) is a sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months)
+Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test (within  days of initiation of protocol therapy) and must be willing to use acceptable methods of birth control; 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\r\n* A female of childbearing potential is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months)
+Non-pregnant and non-nursing women of childbearing potential must have a negative serum or urine pregnancy test (\Women of childbearing potential\ is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding  consecutive months)
+Women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least  consecutive months (e.g., who has had menses any time in the preceding  consecutive months), must have a negative serum pregnancy test =<  days prior to starting study treatment
+Patients with a negative pregnancy test (urine or serum) must be documented within  days of screening for women of childbearing potential (WOCBP); a WOCBP has not undergone a hysterectomy or who has not been naturally postmenopausal for at least  consecutive months (i.e. who has not had menses at any time in the preceding  consecutive months) (Turnstile I)
+Patients with negative pregnancy test (urine or serum) must be documented within  days of screening for WOCBP; a WOCBP has not undergone a hysterectomy or who has not been naturally postmenopausal for at least  consecutive months (i.e. who has not menses at any time in the preceding  consecutive months) (Turnstile II)
+Women who are pregnant or breast feeding or WOCBP not willing to use a double barrier method of contraception during the study and  months after the end of treatment; one of these methods of contraception must be a barrier method; WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least  consecutive months (i.e., who has had menses any time in the preceding  consecutive months); WOCBP must have a negative serum pregnancy test within  days of the first administration of decitabine
+Patients with a negative pregnancy test (urine or serum) must be documented within  days of screening for women of childbearing potential (WOCBP); a WOCBP has not undergone a hysterectomy or who has not been naturally postmenopausal for at least  consecutive months (Turnstile I)
+Women of reproductive potential (a female of reproductive potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least  consecutive months [i.e. has had menses at any time in the preceding  consecutive months]) must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test; all women of reproductive potential, all sexually active male patients, and all partners of patients must agree to use adequate methods of birth control (e.g. latex condoms) throughout the study and for  days after the last dose of study drug
+Women of childbearing potential must have a negative serum pregnancy test within  days of starting study drug. A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least  consecutive months (i.e., who has had menses at any time in the preceding  consecutive months);
+For women of childbearing potential (WCBP): negative serum ?-human chorionic gonadotropin (?hCG) pregnancy test within  week before first dose (WCBP defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally post-menopausal for at least  consecutive months [women ? years] or  consecutive months [women > years])
+Negative serum pregnancy test within  days prior to the first dose of study therapy for women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally post-menopausal for at least  consecutive months (i.e., who has had menses any time in the preceding  consecutive months). Sexually active WCBP and male subjects must agree to use adequate methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for  days after the completion of study treatment.
+Females of child-bearing potential (FCBP) should have a negative urine or serum pregnancy test within  hours prior to enrollment; if urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; FCBP must also be willing to adhere to acceptable forms of birth control (a physician-approved contraceptive method: tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) during the study treatment and through  months after the last dose of talimogene laherparepvec; FCBP are defined as sexually mature women who:\r\n* Have not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or,\r\n* Have not been naturally postmenopausal for at least  consecutive months (i.e. has had menses at any time during the preceding  consecutive months)\r\n* Must be willing to practice abstinence or use effective contraception for a minimum of  months following completion of study treatment (in addition to during study therapy)
+Any of the following\r\n* Pregnant women\r\n* Nursing women\r\n* Men or women of child bearing potential (WCBP) who are unwilling to employ effective contraception; effective contraception would be defined as utilizing  simultaneous methods of contraception from the time of signing consent through  days after the last dose of the study drugs unless they agree to participate in true abstinence when this is in line with the preferred and usual lifestyle of the subject; (women of child bearing potential [WCBP]: a female who is sexually mature and who: [] has not undergone a hysterectomy or bilateral oophorectomy; or [] has not been naturally postmenopausal for at least  consecutive months [i.e., has had menses at any time in the preceding  consecutive months])
+Not pregnant and not nursing\r\n* A female of childbearing potential is a sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months\r\n* For women of childbearing potential only, a negative pregnancy test done =<  days prior to registration is required
+Not pregnant and not nursing:\r\n* A female of childbearing potential is a sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months)
+Females of childbearing potential (FCBP) must have two negative serum or urine pregnancy tests with a sensitivity of at least  mIU/mL prior to starting therapy and prior to beginning another cycle (if applicable); women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; 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; a female of childbearing potential (FCBP) is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months)
+Agreement by woman of childbearing potential and sexually active males to use an effective method of contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for three months following duration of study participation\r\n* A woman of childbearing potential is defined as a sexually mature woman who: \r\n** Has not undergone a hysterectomy or bilateral oophorectomy; or \r\n** Has not been naturally postmenopausal for at least  consecutive months
+Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control; double barrier contraceptives must be used through the trial by both sexes; oral, implantable, or injectable contraceptives may be affected by cytochrome P interactions, and are therefore not considered effective for this study; women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least  consecutive months (i.e., who has had menses any time in the preceding  consecutive months), must have a negative serum pregnancy test =<  hours prior to initiating treatment
+Creatinine ? . mg/dL. . Expected survival of >  weeks for the Induction part of the study. . Eastern Cooperative Oncology Group performance status  or . . For Maintenance part of the study, subjects must have received at least one dose of nab-paclitaxel in each of the  cycles during Induction Pregnancy . Females of childbearing potential [defined as a sexually mature woman who () have not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or () have not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time during the preceding  consecutive months)] must:
+Females of child-bearing potential (defined as a sexually mature woman who: ) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or, ) has not been naturally postmenopausal for at least  consecutive months (ie, has had menses at any time during the preceding  consecutive months) must: a. Agree in writing to use two forms of medical doctor-approved contraception throughout the study (without interruptions while on study treatment) and subsequently for  weeks months. b. Have a negative serum pregnancy test result (minimum sensitivity  IU/L or equivalent units of ? hCG) at screening and  hours prior to the start of any IP and agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy.
+SUB-PROTOCOL AIM A: Women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least  consecutive months (e.g., who has had menses any time in the preceding  consecutive months), must have a negative serum pregnancy test =<  days prior to registration and must use two forms of highly effective contraception (also applicable to their partners who are biologically able to conceive)
+Negative serum pregnancy test within  hours before starting study treatment on Cycle  Day - for females of childbearing potential (FCBP). A female of child-bearing potential, defined as a sexually mature woman who: ) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or, ) has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time during the preceding  consecutive months), may participate providing they agree to the following conditions:
+Not pregnant and not nursing; females of childbearing potential must have negative urine or serum pregnancy test within  days of registration but before start of treatment; a female of childbearing potential is a sexually mature female who: \r\n* Has not undergone a hysterectomy or bilateral oophorectomy; or \r\n* Has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months)
+Females of child-bearing potential (defined as a sexually mature women who):\r\n* Has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or,\r\n* Has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time during the preceding  consecutive months)\r\n* Must have negative serum pregnancy test within  days before starting study treatment in females of childbearing potential (FCBP) and willingness to adhere to acceptable forms or birth control (a physician- approved contraceptive method (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intrauterine device; barrier contraceptive with spermicide; or vasectomized partner)
+Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =<  days prior to registration is required; a female of childbearing potential is a sexually mature female who:\r\n* Has not undergone a hysterectomy or bilateral oophorectomy; or \r\n* Has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months)
+Pregnant or lactating women; women of childbearing potential (WOCB) must have a blood or urine pregnancy test within  days prior to administration of the study drug; (WOCB is defined as a woman who has not undergone hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least  consecutive months)
+Women of reproductive potential* must have a negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy test\r\n* A female of reproductive potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least  consecutive months (i.e. has had menses at any time during the preceding  consecutive months)
+Female of childbearing potential (FCBP) (defined as a sexually mature woman who ) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or, ) if ?  years old has not been naturally postmenopausal for at least  consecutive months (ie, has had menses at any time during the preceding  consecutive months) must:
+Women of childbearing potential (a woman of child-bearing potential is a reproductively mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least  consecutive months [i.e., who has had menses at any time in the preceding  consecutive months]) and male participants must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study
+Subject is a female of Childbearing Potential [defined as a sexually mature woman who () has not undergone hysterectomy (the surgical removal of the uterus) or bilateral oopherectomy (the surgical removal of both ovaries) or () has not been naturally postmenopausal for at least  consecutive months (ie, has had menses at any time during the preceding  consecutive months)].
+Females of child-bearing potential (FCBP) must have negative serum pregnancy test within  days before starting study treatment and willingness to adhere to acceptable forms of birth control (a physician-approved contraceptive method: oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) for a minimum of  weeks following the discontinuation of study treatment; FCBP is defined as a sexually mature woman who:\r\n* Has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or,\r\n* Has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time during the preceding  consecutive months
+Women of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program; men must agree to use a latex condom during sexual contact with a female of childbearing potential (FCBP) even if they have had a successful vasectomy\r\n* A female of reproductive potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least  consecutive months (i.e. has had menses at any time in the preceding  consecutive months)
+Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test and must be willing to use acceptable methods of birth control during the study and for  days after the last dose of study treatment; * a female of childbearing potential is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months)
+Women of childbearing potential (defined as a sexually mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding  consecutive months)
+For women of childbearing potential (WCBP): negative serum ?-human chorionic gonadotropin (?hCG) pregnancy test within  week before randomization (WCBP defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally post-menopausal for at least  consecutive months [women ?  years] or  consecutive months [women >  years])
+Women of childbearing potential (WOCBP) must agree to ongoing pregnancy testing and to practice contraception and required by the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program\r\n* A woman of childbearing potential is a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy or has not been naturally postmenopausal for at least  consecutive months (i.e. has had menses at any time in the preceding  consecutive months)
+Women who are pregnant or breast-feeding or adults of reproductive potential not employing an effective method of birth control; double barrier contraceptives must be used through the trial by both sexes; oral, implantable, or injectable contraceptives may be affected by cytochrome P interactions, and are therefore not considered effective for this study; women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least  consecutive months (i.e., who has had menses any time in the preceding  consecutive months), must have a negative serum pregnancy test =<  hours prior to initiating treatment
+Females of childbearing potential (FCBP) (defined as sexually mature females who: have not undergone a hysterectomy or bilateral oophorectomy; or have not been naturally postmenopausal for at least  consecutive months [ie, has had menses at any time in the preceding  consecutive months]) must agree to ongoing pregnancy testing
+Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program; men must agree to use a latex condom during sexual contact with a female of childbearing potential (FCBP) even if they have had a successful vasectomy\r\n* A female of childbearing potential is a sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months)
+Women who are pregnant or breast-feeding or women of childbearing potential (WOCBP) not using an effective method of birth control; WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least  consecutive months (i.e., who has had menses any time in the preceding  consecutive months); women of childbearing potential must have a negative serum pregnancy test within  hrs of receiving the first dose of study medication
+Women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least  consecutive months) must agree to practice adequate contraception and to refrain from breast feeding
+Negative serum pregnancy test in women of childbearing potential; this is a female who has not been postmenopausal for at least  consecutive months or who has not undergone previous surgical sterilization
+Negative pregnancy test for women of childbearing potential (WOCBP); a WOCBP has not undergone a hysterectomy or who has not been naturally postmenopausal for at least  consecutive months (i.e., who has had menses at any time in the preceding  consecutive months)
+Females of childbearing potential (FCBP) (defined as a sexually mature woman who () has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or () has not been naturally postmenopausal for at least  consecutive months [i.e., has had menses at any time during the preceding  consecutive months]) must:
+Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test within  days of initiation of therapy; a female of childbearing potential is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months)
+Patients participating in the study are to use adequate birth control measures (abstinence, oral contraceptives, barrier method with spermicide or surgical sterilization) during study participation. Females of childbearing potential must have a negative serum pregnancy test on the days of dosing. A female of childbearing potential is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months.
+Females of child-bearing potential (FCBP) must have negative serum pregnancy test within  days before starting study treatment and willingness to adhere to acceptable forms or birth control (a physician- approved contraceptive method: oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner); FCBP is defined as a sexually mature women who:\r\n* Have not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or,\r\n* Have not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time during the preceding  consecutive months)\r\n* Must be willing to practice abstinence or use highly effective contraception for a minimum of  months following completion of study treatment (in addition to during study therapy)
+Females of childbearing potential [defined as a sexually mature woman who () have not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or () have not been naturally postmenopausal for at least  consecutive months (ie, has had menses at any time during the preceding  consecutive months)] must:
+Patients participating in the study are to use adequate birth control measures (abstinence, oral contraceptives, barrier method with spermicide or surgical sterilization) during study participation. Females of childbearing potential must have a negative serum pregnancy test on the days of dosing. A female of childbearing potential is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months.
+Women of child-bearing potential, who are biologically able to conceive, not employing two forms of highly effective contraception; highly effective barrier contraception must be used throughout the trial and  weeks after the last dose of study drug (e.g. male condom with spermicidal diaphragm with spermicide; intra-uterine device); oral, interactions are not considered effective for this study; women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least  consecutive months (i.e., who has had menses any time in the preceding  consecutive months), must have a negative serum pregnancy test =<  days prior to starting study drug
+Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not using an effective method of birth control; WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least  consecutive months (i.e., who has had menses any time in the preceding  consecutive months); women of childbearing potential must have a negative serum pregnancy test within hrs of receiving the first dose of study medication
+Participants of childbearing potential, defined as a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months), must have a negative urine or serum pregnancy test within  weeks prior to enrollment and agree to use an effective form of contraception (e.g., barrier contraception, highly effective hormonal contraception)
+Female patients of child-bearing potential (FCBP) must have a negative serum pregnancy test within  days prior to randomization and agree to use an effective method of contraception during and for  months following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations). FCBP is defined as a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy or ) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months).
+ A FCBP is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy or ) has not been naturally postmenopausal (i.e., amenorrhea following cancer therapy does not rule out childbearing potential) for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months).
+Patients with a negative pregnancy test (urine or serum) must be documented within  days of screening for women of childbearing potential (WOCBP); a WOCBP has not undergone a hysterectomy or who has not been naturally postmenopausal for at least  consecutive months (i.e. who has not had menses at any time in the preceding  consecutive months)
+Women of child-bearing potential (sexually mature women) who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least  consecutive months (i.e., who has had menses any time in the preceding  consecutive months), must have a negative serum pregnancy test =<  days prior to starting study drug
+Negative serum or urine beta-human chorionic gonadotropin (HCG) in women of child-bearing potential =<  days prior to registration; a female of childbearing potential is a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least  consecutive months
+Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =<  days prior to registration is required; a female of childbearing potential is a sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months)
+Negative pregnancy test (serum or urine) done =<  days prior to registration, for women of childbearing potential only\r\n* A female of childbearing potential is a sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months)
+Pregnant women are excluded from this study; women of childbearing potential (defined as those who have not undergone defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least  consecutive months) must agree to practice adequate contraception and to refrain from breast-feeding, as specified in the informed consent
+Has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months); women of child-bearing potential has negative pregnancy test prior to initiating study drug dosing
+Women of childbearing potential (FCBP)* must have a negative urine pregnancy test within  days prior to randomization enrollment; female participants enrolled in the treatment arm are advised to not become pregnant during study participation; all women of childbearing potential must agree to either commit to continued abstinence from heterosexual intercourse or to use a reliable birth control method during heterosexual intercourse (oral contraceptive pills, intrauterine device, Nexplanon, DepoProvera, or bilateral tubal ligation, etc., or another acceptable method as determined by the investigator) during the entire period of the trial ( years or more), and must not intend to become pregnant during study participation and for  months after treatment is discontinued if the participant is enrolled in the treatment arm; female participants, if engaging in heterosexual intercourse, must be willing to comply with an acceptable birth control regimen as determined by the investigator\r\n* A female of childbearing potential is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; ) has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months)
+Men whose partner is a woman of child-bearing potential, (i.e. biologically able to conceive), and who is not employing two forms of highly effective contraception; highly effective contraception (e.g. male condom with spermicide, diaphragm with spermicide, intra-uterine device) must be used by both sexes during the study and must be continued for  months after the end of study treatment; women of child-bearing potential is defined as sexually mature women who are not surgically sterile or who have not been naturally postmenopausal for at least  consecutive months (e.g., who has had menses any time in the preceding  consecutive months)
+Women of childbearing potential are required to have a beta human chorionic gonadotropin (BHCG) serum or urine pregnancy test performed within  days prior to first study drug dose; a female of childbearing potential is a sexually mature woman who:\r\n* Has not undergone a hysterectomy or bilateral oophorectomy\r\n* Has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months)
+Females of childbearing potential (FCBP); a female of childbearing potential is a sexually mature woman who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least  consecutive months (i.e., has not had menses at any time in preceding  consecutive months)
+Pregnant women are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least  consecutive months) must agree to practice adequate contraception and to refrain from breast-feeding, as specified in the informed consent
+Negative pregnancy test done =<  days prior to registration/randomization, for women of childbearing potential only\r\n* A female of childbearing potential is a sexually mature female who: ) has not undergone a hysterectomy or bilateral oophorectomy; or ) has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months)
+Participants of childbearing potential, defined as a sexually mature woman who: () has not undergone a hysterectomy or bilateral oophorectomy or () has not been naturally postmenopausal for at least  consecutive months (i.e., has had menses at any time in the preceding  consecutive months), must have a negative urine or serum pregnancy test within  weeks prior to enrollment and agree to use an effective form of contraception (e.g., barrier contraception or hormonal contraception), delaying pregnancy for at least  months and ideally for the duration of the study; Note: those willing to participate delay pregnancy for at least  months, while receiving the recombinant human papillomavirus nonavalent (vHPV) vaccine (or placebo) through the primary endpoint at week ; Note: breastfeeding women are eligible for the trial if meeting all other entry criteria