 - Males or females of reproductive potential may not participate unless they have agreed to practice 1 highly effective and 1 additional effective barrier method of contraception at the same time during the entire study treatment period and through 4 months after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence e.g., calendar, ovulation, symptothermal, post-ovulation methods, withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception 