 OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study: abstinence; oral contraceptive, either combined or progestogen alone; injectable progestogen; implants of levonorgestrel; estrogenic vaginal ring; percutaneous contraceptive patches; intrauterine device IUD or intrauterine system IUS that meets the standard operating procedure effectiveness criteria as stated in the product label; male partner sterilization vasectomy with documentation of azoospermia prior to the female subjects entry into the study, and this male is the sole partner for that subject; double barrier method: condom and an occlusive cap diaphragm or cervicalvault caps with a vaginal spermicidal agent foamgelfilmcreamsuppository 