Negative pregnancy test done =< days prior to registration, for women of childbearing potential only For women of childbearing potential only: a negative urine or serum pregnancy test done =< days prior to pre-registration is required Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< days prior to registration is required Not pregnant and not nursing; therefore, for women of childbearing potential only, a negative pregnancy test done =< days prior to re-registration is required Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< days prior to registration is required Not pregnant and not nursing; women of childbearing potential only, a negative pregnancy test done =< days prior to registration is required Negative serum or urine pregnancy test done =< days prior to registration, for women of childbearing potential only Negative serum pregnancy test within days prior to registration for women of childbearing potential Negative serum pregnancy test within weeks prior to registration for women of childbearing potential Not pregnant and not nursing; for women of childbearing potential only, a negative urine or serum pregnancy test done =< days prior to registration is required Not pregnant and not nursing; for women of childbearing potential only, a negative pregnancy test done =< days prior to registration is required Negative serum pregnancy test for women of childbearing potential Negative pregnancy test performed =< days prior to registration (women of childbearing potential only) Negative pregnancy test within weeks prior to treatment for women of childbearing potential Women of childbearing potential must have a negative pregnancy test Women of childbearing potential must have a negative serum pregnancy test less than or equal to days prior to registration. Negative serum pregnancy test for women of childbearing potential Negative serum pregnancy test in women of childbearing potential Women of childbearing potential must have a negative pregnancy test Not pregnant and not nursing; for women of childbearing potential only, a negative serum pregnancy test done =< days prior to registration is required Women of childbearing potential must have a negative serum pregnancy test within days prior to registration Women of childbearing potential must have a negative serum pregnancy test Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Women of childbearing potential must have a negative qualitative serum pregnancy test =< days prior to Step registration Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Women of childbearing potential must have a negative pregnancy test within days of registration Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Women of childbearing potential must have a negative pregnancy test. Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative pregnancy test (within days of enrollment) in women of childbearing potential Negative pregnancy test done ? days prior to registration, for women of childbearing potential only Negative pregnancy test (women of childbearing potential) Negative serum pregnancy test for persons of childbearing potential =< days prior to registration Negative urine pregnancy test done =< days prior to registration, for women of childbearing potential only Negative pregnancy test done =< days prior to registration, for persons of childbearing potential only Negative serum pregnancy test within days prior to registration for women of childbearing potential Negative pregnancy test done =< days prior to registration, for persons of childbearing potential only Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative serum or urine pregnancy test within weeks before registration for women of childbearing potential Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative pregnancy test done =< days prior to registration, for women of childbearing potential only For women of childbearing age, negative pregnancy test within days prior to registration Pregnancy restrictions - Women of childbearing potential must have a negative B-HCG documented within days prior to registration Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative serum pregnancy test done =< days prior to registration, for women of childbearing potential only Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative pregnancy test for women of childbearing potential within days prior to registration Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative serum pregnancy test done =< days prior to registration, for women of childbearing potential only Negative serum pregnancy test (women of childbearing potential only) Negative serum pregnancy test for women of childbearing potential Negative serum pregnancy test for women of childbearing potential A negative pregnancy test within 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 =< days prior to registration, for women of childbearing potential only Negative serum pregnancy test in women of childbearing potential Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative pregnancy test performed =< days prior to registration for women of childbearing potential only Negative serum or urine pregnancy test done =< days prior to registration, for persons of childbearing potential only Negative serum pregnancy test done =< days prior to registration, for women of childbearing potential only Women of childbearing potential who have negative pregnancy test results Negative pregnancy test in women of childbearing potential Negative serum pregnancy test done ? 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 days of registration. Negative pregnancy test done at screening and ? days ( hours) prior to registration, for women of childbearing potential Negative pregnancy test performed =< days prior to registration (women of childbearing potential only) Negative pregnancy test done =< days prior to registration, for persons of childbearing potential only Women of childbearing potential must have a negative pregnancy test within days of registration Negative pregnancy test done =< 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 =< days prior to registration is required Negative serum pregnancy test done =< days prior to randomization, for women of childbearing potential only For women of childbearing potential, a negative serum pregnancy test within days of registration Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative urine or serum pregnancy test within days prior to registration for women of childbearing potential ARM A: Negative serum pregnancy test =< days prior to registration for women of childbearing potential only ARM B: Negative serum pregnancy test =< days prior to registration for women of childbearing potential only Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative serum pregnancy test done =< days prior to registration, for women of childbearing potential only For women of childbearing potential only: negative urine or serum pregnancy test done =< days prior to registration Women of childbearing potential must have a negative serum pregnancy test within days prior to registration or randomization Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative serum pregnancy test done =< days prior to registration (for women of childbearing potential only) Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative serum pregnancy test within days prior to registration for women of childbearing potential Women of childbearing potential only: negative serum pregnancy test done =< days prior to registration Negative serum or urine pregnancy test within days prior to registration for women of childbearing potential For women of childbearing potential, a negative serum pregnancy test within days prior to step registration For women of childbearing potential, a negative serum pregnancy test within weeks of registration Women of childbearing potential must have a negative pregnancy test Negative serum pregnancy test for women of childbearing potential within days of study registration Negative serum pregnancy test within 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 days prior to registration Women of childbearing potential must have a negative pregnancy test within days prior to registration for protocol therapy. Negative serum pregnancy test done =< days prior to registration for women of childbearing potential only Negative pregnancy test done =< days prior to randomization, for women of childbearing potential only Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative pregnancy test done =< days prior to registration, for women of childbearing potential only For women of childbearing potential, a negative serum pregnancy test =< days prior to registration Negative serum or urine pregnancy test done =< days prior to registration, for women of childbearing potential only Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Women of childbearing potential must have a negative pregnancy test Negative pregnancy test (women of childbearing potential) Negative serum or urine pregnancy test within weeks prior to registration for women of childbearing potential Negative serum pregnancy test done =< days prior to registration, for women of childbearing potential only Negative pregnancy test (women of childbearing potential only) Women of childbearing potential must have negative serum pregnancy test performed within -days prior to registration Negative pregnancy test for women of childbearing potential Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Women of childbearing potential must have a negative pregnancy test within days prior to study registration. Women should be counseled regarding acceptable birth control methods to utilize from the time of screening to start of treatment. If prior to treatment after discussion with the subject it is felt by the treating physician there is a possibility the subject is pregnant a pregnancy test should be repeated. Women of childbearing potential must have a negative pregnancy test within days prior to study registration. Negative serum pregnancy test within days prior to registration for women of childbearing potential Negative serum pregnancy test done =< days prior to registration, for women of childbearing potential only Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Women of childbearing potential must have a negative serum pregnancy test =< days prior to registration Women of childbearing potential must have a negative pregnancy test within days of registration Negative pregnancy test performed =< days prior to registration, for women of childbearing potential only Women of childbearing potential must have a negative pregnancy test within days prior to study treatment Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Women of childbearing potential only: negative pregnancy test done =< days prior to registration Negative pregnancy test done =< days prior to randomization, for women of childbearing potential only Women of childbearing potential must have a negative beta-HCG pregnancy test documented within weeks prior to registration. Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative serum pregnancy test in women of childbearing potential Negative serum pregnancy test done =< days prior to registration, for women of childbearing potential only Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative serum pregnancy test in women of childbearing potential; Negative pregnancy test for women of childbearing potential Women of childbearing potential have a negative pregnancy test Negative serum pregnancy test done =< days prior to registration for women of childbearing potential only For women of childbearing potential, negative serum pregnancy test; Negative urine or serum pregnancy test =< 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 =< days prior to pre-registration is required Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative pregnancy test for women of childbearing potential Negative serum pregnancy test within days prior to registration for women of childbearing potential Negative serum pregnancy test =< days prior to pre-registration for women of childbearing potential Negative pregnancy test within weeks prior to registration for women of childbearing potential Negative serum pregnancy test done =< days prior to registration, for women of childbearing potential only Negative serum pregnancy test for female subjects with reproductive potential =< days prior to registration, for women of childbearing potential only Women of childbearing potential only: negative serum pregnancy test done =< days prior to registration Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative serum pregnancy test done =< days prior to registration, for women of childbearing potential only Women of childbearing potential must have a negative blood pregnancy test Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative pregnancy test for women of childbearing potential Women of childbearing potential must have a negative pregnancy test to be eligible Negative pregnancy test for women of childbearing potential Not pregnant and not nursing\r\n* For women of childbearing potential only, a negative pregnancy test done =< days prior to registration is required Negative serum pregnancy test done =< days prior to registration, for persons of childbearing potential only Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Women of childbearing potential must have a negative urine or serum pregnancy test within days prior to registration Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative serum pregnancy test done =< 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 days prior to registration Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative serum pregnancy test within weeks prior to registration for women of childbearing potential Negative pregnancy test for women of childbearing potential Negative pregnancy test done =< days prior to registration (for women of childbearing potential only) Not pregnant; for women of childbearing potential only, a negative pregnancy test done =< days prior to registration is required Women of childbearing potential : negative pregnancy test Negative serum pregnancy test within weeks prior to registration for women of childbearing potential Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative urine or serum pregnancy test performed =< days prior to registration, for women of childbearing potential only Negative (serum) pregnancy test done =< days prior to randomization, for women of childbearing potential only Negative pregnancy test done ? days prior to registration, for women of childbearing potential Negative pregnancy test done =< days prior to registration, for women of childbearing potential only Negative pregnancy test for women of childbearing potential Women of childbearing potential must have a negative pregnancy test Negative serum pregnancy test in women of childbearing potential Negative pregnancy test done =< days prior to registration, for women of childbearing potential only