12. Female Subjects Contraception Methods: a) Abstinence; b) Intrauterine device (IUD) or intrauterine system (IUS) that meets the <1% failure rate as stated in the product label; c) Male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject; d) Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository).