 - Females who were pregnant, breastfeeding or, if of child-bearing potential, unwilling to practice a highly effective method of contraception oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device IUD or intrauterine system IUS, condom or occlusive cap with spermicidal foamgelfilmcreamsuppository, male sterilization, or abstinence throughout the study 