 8. Females of childbearing potential FCBPmust have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below: Option 1: Any one of the following highly effective methods: hormonal contraception oral, injection, implant, transdermal patch, vaginal ring; intrauterine device IUD; tubal ligation; or partners vasectomy; OR Option 2: Male or female condom latex condom or nonlatex condom NOT made out of natural animal membrane for example, polyurethane PLUS one additional barrier method: a diaphragm with spermicide; b cervical cap with spermicide; or c contraceptive sponge with spermicide. 