Women must not be pregnant or breastfeeding; all females of childbearing potential (not surgically sterilized and between menarche and year post menopause) must have a blood or urine test to rule out pregnancy within weeks prior to registration Pregnant or breast feeding; females of childbearing potential must have a blood test or urine study within days prior to registration to rule out pregnancy Pregnant or breastfeeding - females of childbearing potential must have a blood test or urine study within days prior to registration to rule out pregnancy Pregnant or breast feeding; females of childbearing potential must have a blood test or urine study within days prior to registration to rule out pregnancy Pregnant or breast feeding; the agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk; all females of childbearing potential must have a blood test or urine study within weeks prior to registration to rule out pregnancy Pregnant or breast feeding; all females of childbearing potential must have a blood or urine pregnancy test within weeks prior to enrollment to rule out pregnancy If female, patient must not be pregnant or breastfeeding; all females of childbearing potential must have a blood test or urine study within weeks prior to randomization to rule out pregnancy Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within weeks prior to registration to rule out pregnancy Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within weeks prior to registration to rule out pregnancy Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within weeks prior to randomization to rule out pregnancy Women must not be pregnant or breast-feeding\r\n* All females of childbearing potential must have a blood test or urine study within weeks prior to randomization to rule out pregnancy Pregnant or lactating; the agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk; all females of childbearing potential must have a blood test or urine study within days prior to registration to rule out pregnancy; women of childbearing age must use appropriate contraceptive method Pregnant or breast feeding; all females of childbearing potential must have a blood test or urine study within weeks prior to registration to rule out pregnancy Pregnant or lactating; all females of childbearing potential must have a blood test or urine study within weeks prior to registration to rule out pregnancy Pregnant or breast feeding; females of childbearing potential must have a blood test or urine study within days prior to registration to rule out pregnancy Pregnant or breast feeding; females of childbearing potential must have a blood test or urine study within days prior to registration to rule out pregnancy Women must not be pregnant or breast-feeding as the agents used in this study may be teratogenic to a fetus and there is no information on the excretion of the agents or their metabolites into breast milk; all females of childbearing potential must have a blood test or urine study within weeks prior to registration to rule out pregnancy All females of childbearing potential must have a blood test or urine study within weeks prior to registration to rule out pregnancy