No patients that are known to be pregnant or nursing
Not pregnant or nursing
Non-pregnant and non-nursing; women and men of reproductive potential should agree to use an effective means of birth control
STEP I: The following patients will be excluded:* Pregnant women* Nursing women
STEP II: The following patients will be excluded:* Pregnant women* Nursing women
Patients must not be pregnant or nursing* Note: Peri-menopausal women must be amenorrheic for > 12 months to be considered not of childbearing potential
Pregnant women or nursing mothers
Study drug must not be administered to pregnant women or nursing mothers
Pregnant or nursing women
Pregnant or nursing women
Pregnancy or nursing or unwilling to take adequate birth control during therapy
Pregnant or nursing patients
Nursing women who are unwilling to discontinue nursing
Pregnancy and/or nursing females
Pregnant or nursing female patients are excluded from this study