- Reproductive status: A participant who was born female must either: (1) Agree to consistently use effective contraception for sexual activity that could lead to pregnancy, from at least 21 days prior to enrollment through the last required protocol clinic visit. Effective contraception is defined as using any of the following methods: condoms (male or female) with or without a spermicide, diaphragm or cervical cap with spermicide, intrauterine device (IUD), hormonal contraception, or successful vasectomy in the male partner (considered successful if a participant reports that a male partner has either documentation of azoospermia by microscopy or a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy); or (2) Not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation; or (3) Be sexually abstinent.