Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required Not pregnant and not nursing; therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to re-registration is required Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required Not pregnant and not nursing; women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required Negative serum or urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required Negative pregnancy test performed =< 7 days prior to registration (women of childbearing potential only) Women of childbearing potential must have a negative serum pregnancy test less than or equal to 7 days prior to registration. Not pregnant and not nursing; for women of childbearing potential only, a negative serum pregnancy test done =< 7 days prior to registration is required Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Women of childbearing potential must have a negative qualitative serum pregnancy test =< 14 days prior to Step 1 registration Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Women of childbearing potential must have a negative pregnancy test within 14 days of registration Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative pregnancy test done ? 7 days prior to registration, for women of childbearing potential only Negative serum pregnancy test for persons of childbearing potential =< 7 days prior to registration Negative urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only For women of childbearing age, negative pregnancy test within 14 days prior to registration Pregnancy restrictions - Women of childbearing potential must have a negative B-HCG documented within 7 days prior to registration Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative pregnancy test for women of childbearing potential within 14 days prior to registration Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only A negative pregnancy test within 7 days prior to registration for women of childbearing potential; in addition, male and female participants must commit to adequate contraception while on study Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative pregnancy test performed =< 7 days prior to registration for women of childbearing potential only Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative serum pregnancy test done ? 7 days prior to registration, for persons of childbearing potential only Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test prior to baseline. Women of childbearing potential must have a negative serum pregnancy test as a part of eligibility, within 28 days of registration. Negative pregnancy test done at screening and ? 3 days (72 hours) prior to registration, for women of childbearing potential Negative pregnancy test performed =< 7 days prior to registration (women of childbearing potential only) Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only Women of childbearing potential must have a negative pregnancy test within 30 days of registration Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required For women of childbearing potential, a negative serum pregnancy test within 14 days of registration Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative urine or serum pregnancy test within 14 days prior to registration for women of childbearing potential ARM A: Negative serum pregnancy test =< 7 days prior to registration for women of childbearing potential only ARM B: Negative serum pregnancy test =< 7 days prior to registration for women of childbearing potential only Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only For women of childbearing potential only: negative urine or serum pregnancy test done =< 7 days prior to registration Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration or randomization Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative serum pregnancy test done =< 7 days prior to registration (for women of childbearing potential only) Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential Women of childbearing potential only: negative serum pregnancy test done =< 14 days prior to registration Negative serum or urine pregnancy test within 3 days prior to registration for women of childbearing potential For women of childbearing potential, a negative serum pregnancy test within 14 days prior to step 2 registration For women of childbearing potential, a negative serum pregnancy test within 2 weeks of registration Negative serum pregnancy test for women of childbearing potential within 14 days of study registration Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential Negative serum pregnancy test within three days prior to registration for women of childbearing potential Women of childbearing potential must have a negative pregnancy test prior to registration. Pregnancy or lactating females; women of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration Women of childbearing potential must have a negative pregnancy test within 14 days prior to registration for protocol therapy. Negative serum pregnancy test done =< 7 days prior to registration for women of childbearing potential only Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only For women of childbearing potential, a negative serum pregnancy test =< 7 days prior to registration Negative serum or urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Women of childbearing potential must have negative serum pregnancy test performed within 7-days prior to registration Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Women of childbearing potential must have a negative serum pregnancy test =< 7 days prior to registration Women of childbearing potential must have a negative pregnancy test within 14 days of registration Negative pregnancy test performed =< 7 days prior to registration, for women of childbearing potential only Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Women of childbearing potential only: negative pregnancy test done =< 7 days prior to registration Women of childbearing potential must have a negative beta-HCG pregnancy test documented within 2 weeks prior to registration. Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative serum pregnancy test done =< 7 days prior to registration for women of childbearing potential only Negative urine or serum pregnancy test =< 14 days prior to registration for women of childbearing potential Not pregnant and not nursing; for women of childbearing potential only, a negative serum pregnancy test pregnancy test done =< 7 days prior to pre-registration is required Negative pregnancy test done =< 14 days prior to registration, for women of childbearing potential only Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential Negative serum pregnancy test =< 7 days prior to pre-registration for women of childbearing potential Negative pregnancy test within 2 weeks prior to registration for women of childbearing potential Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative serum pregnancy test for female subjects with reproductive potential =< 7 days prior to registration, for women of childbearing potential only Women of childbearing potential only: negative serum pregnancy test done =< 7 days prior to registration Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Not pregnant and not nursing\r\n* For women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required Negative serum pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to registration Negative pregnancy test done =< 14 days prior to registration, for women of childbearing potential only Negative serum pregnancy test done =< 7 days prior to registration only for women determined to be of childbearing potential by their treating physician Women of childbearing age must have a negative serum pregnancy test within 14 days prior to registration Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential Negative pregnancy test done =< 7 days prior to registration (for women of childbearing potential only) Not pregnant; for women of childbearing potential only, a negative pregnancy test done =< 28 days prior to registration is required Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative pregnancy test done ? 7 days prior to registration, for women of childbearing potential Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only