Women of child-bearing potential (WOCBP) 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 (see timelines below for women and men); in addition, men must agree not to donate sperm during and after study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* NOTE: for female patients, these restrictions apply for month after the last dose of study drug; for male patients, these restrictions apply for months after the last dose of study drug\r\n* NOTE: a female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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 must have a negative pregnancy test within days of study enrollment and must agree to use an effective method of birth control during treatment and for three months after receiving their last dose of study drug; males must agree to use an effective method of birth control during treatment and for three months after receiving their last dose of study drug; all patients must notify treating provider immediately if any suspicion of pregnancy or conception\r\n* Child-bearing potential is defined as any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: \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) Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; a woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) Women of child-bearing potential and their male partners also of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; a woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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)\r\n* NOTE: Acceptable forms of birth control are listed below:\r\n** One Barrier method (cervical cap with spermicide plus male condom; diaphragm with spermicide plus male condom)\r\n** PLUS\r\n** Hormonal method (oral contraceptives, implants, or injections) or an intrauterine device (e.g., Copper-T) Women of child-bearing potential and men with partners of child-bearing potential must agree 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; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) 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\r\n* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) from time of consent and for the duration of study participation as well as for months after the completion of study drug; adequate contraception consists of a double method of contraception, one method of which must be a barrier method; women of child-bearing potential (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); if a woman (or a male subjects female partner) becomes pregnant or suspects she is pregnant while she is participating in this study, she should inform her treating physician immediately Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) 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, for the duration of protocol treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) 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\r\n* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) 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 protocol therapy\r\n* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) PHASE I: Women of child-bearing potential must have a negative pregnancy test prior to study entry and agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A woman of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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)\r\n* Contraception: Women of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions for days after the last dose of investigation products; the male partner of a female subject must also use male condom plus spermicide throughout this period; cessation of birth control after this point should be discussed with a responsible physician; not engaging in sexual activity is an acceptable practice; however, occasional abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception; female patients should refrain from breastfeeding and egg cell donation throughout this period PHASE II: Women of child-bearing potential must have a negative pregnancy test prior to study enrollment and agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A woman of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria\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)\r\n* Contraception: Women of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions for days after the last dose of investigational products; the male partner of a female subject must also use male condom plus spermicide throughout this period; cessation of birth control after this point should be discussed with a responsible physician; not engaging in sexual activity is an acceptable practice; however, occasional abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception; female patients should refrain from breastfeeding and egg cell donation throughout this period 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, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for days following completion of therapy \r\n* A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* Note: a woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) 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, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately;\r\n* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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\r\n* 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, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) DONOR: Pregnant or lactating\r\n* 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, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) 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, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* Female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) 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, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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)\r\n* Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: >= years old and no menses for >= year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry 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, for the duration of protocol treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; a female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) 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) Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; a woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) Women of child-bearing potential must agree to use adequate contraception (double barrier method of birth control or abstinence) prior to study entry, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) DOSE ESCALATION COHORT: Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception (hormonal AND barrier method of birth control) prior to study entry, for the duration of study participation, and for days following completion of therapy; if a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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)\r\n* Men of child-bearing potential must not donate sperm while on this study and for days after their last study treatment; NOTE: acceptable forms of birth control are listed below:\r\n** One barrier method (cervical cap with spermicide plus male condom; diaphragm with spermicide plus male condom) PLUS\r\n** Hormonal method (oral contraceptives, implants, or injections) or an intrauterine device (e.g., Copper-T) DOSE EXPANSION COHORT: Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception (hormonal AND barrier method of birth control) prior to study entry, for the duration of study participation, and for days following completion of therapy; if a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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)\r\n* Men of child-bearing potential must not donate sperm while on this study and for days after their last study treatment; NOTE: acceptable forms of birth control are listed below:\r\n** One barrier method (cervical cap with spermicide plus male condom; diaphragm with spermicide plus male condom) PLUS\r\n** Hormonal method (oral contraceptives, implants, or injections) or an intrauterine device (e.g., Copper-T) Women of child bearing potential (WOCBP) and their partners must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for days following completion of therapy; after confirmation of negative pregnancy test at screening, should a WOCBP become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician and the investigator immediately\r\n* WOCBP are defined as any females (regardless of sexual orientation, having undergone tubal ligation, or remaining celibate by choice) who meet the following criteria:\r\n** Have not undergone a hysterectomy or bilateral oophorectomy OR\r\n** Have 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 and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for days following completion of therapy; should a woman or partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and the investigator immediately\r\n* A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) Women of child-bearing potential (WOCBP) and their partners must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for months following last dose of investigational drug; after confirmation of negative pregnancy test at screening, should a WOCBP become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and the investigator immediately; the outcome of the pregnancy will be followed and reported to Bristol-Myers Squibb (BMS)\r\n* WOCBP are any females (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meet the following criteria:\r\n** Have not undergone a hysterectomy or bilateral oophorectomy; OR\r\n** Have 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 and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for months following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; a female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) 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) Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) 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, for the duration of study participation, and for months following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; a female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) 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) 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, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) Woman of child-bearing potential and man with partners of child-bearing potential agrees to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) 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, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\r\n** Has not undergone a hysterectomy or bilateral oophorectomy\r\n** 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 and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; a female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) 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) 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, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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 and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A female of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\r\n** Has not undergone a hysterectomy or bilateral oophorectomy; or Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for days following completion of therapy; a woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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 not had menses at any time in the preceding consecutive months) Women of child-bearing potential must agree to use adequate contraception (barrier method of birth control or abstinence - hormonal contraception is not allowed while participating in this study) prior to study entry, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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) 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, for the duration of study participation, and for days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\r\n* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\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)