 - For women who are not postmenopausal 12 months of non-therapy-induced amenorrhea or surgically sterile absence of ovaries andor uterus, agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of 1 per year during the treatment period and for at least 3 months after the last dose of study drug. Abstinence is acceptable only if it is in line with the preferred and usual lifestyle of the participant. Periodic abstinence e.g., calendar, ovulation, symptothermal, or postovulation methods and withdrawal are not acceptable methods of contraception. Examples of contraceptive methods with a failure rate of 1 per year include tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices. Alternatively, two methods e.g., two barrier methods such as a condom and a cervical cap may be combined to achieve a failure rate of 1 per year. Barrier methods must always be supplemented with the use of a spermicide 