- Females of reproductive potential (defined as women who have not been post-menopausal for at least 24 consecutive months [i.e., who have had menses within 24 months prior to study entry, or women who have not undergone surgical sterilization, specifically hysterectomy, tubal ligation, and/or bilateral oophorectomy]) must have a negative serum or urine pregnancy test with a sensitivity of less than or equal to 25 mIU/mL within 42 days prior to study entry by any U.S. laboratory that has a CLIA certification or its equivalent.