 12. Male participants who were not abstinent or have not undergone a successful vasectomy, who were partners of women of childbearing potential must have used, or their partners must have used a highly effective method of contraception eg, condom spermicide, condom diaphragm with spermicide, IUD starting prior to starting study drugs and throughout the entire study period and for 30 days after the last dose of study drug. Those with partners using hormonal contraceptives must also have used an additional approved method of contraception as described previously 