 - For men, agreement to remain abstinent or use a condom plus an additional contraceptive method that together 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 