NOTE: Acceptable methods of contraception may include one or more of the following: 1) male partner who is sterile prior to the female participant's entry into the study and is the sole sexual partner for the female participant; 2) implants of levonorgestrel; 3) injectable progestogen;, 4) an intrauterine device with a documented failure rate of less than 1percent; 5) oral contraceptives; or 6) double barrier methods including diaphragm or condom with a spermicide.