 - Females of childbearing potential who are, in the opinion of the Investigator, practicing a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method condom or occlusive cap diaphragm or cervical vault caps plus spermicidal agent foam, gel, film, cream, suppository OR male partner sterilization prior to the female participants entry into the study, and this male is the sole partner for that participant. 