Women must not be pregnant or breastfeeding; all females of childbearing potential (not surgically sterilized and between menarche and 1 year post menopause) must have a blood or urine test to rule out pregnancy within 2 weeks prior to registration Pregnant or breast feeding; females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy Pregnant or breastfeeding - females of childbearing potential must have a blood test or urine study within 14 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 14 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 2 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 2 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 2 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 2 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 2 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 2 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 2 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 14 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 2 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 2 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 14 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 14 days prior to registration to rule out pregnancy Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of childbearing potential at screening 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 2 weeks prior to registration to rule out pregnancy All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy BIODISTRIBUTION COHORT: Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening DYNAMIC COHORT: Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening