 7. Female participants of childbearing potential in this study must agree to use an effective form of birth control during study participation. Reliable and effective forms of birth control include: true abstinence, intrauterine device IUD, hormonal-based contraception, double-barrier contraception condom or occlusive cap diaphragm or cervical cap with spermicide, or surgical sterilization vasectomy for male partner, tubal ligation or hysterectomy. Sexually active male participants must agree to use an effective form of birth control such as condoms. 