childbearing potential female contraception non subjects use women females willing effective contraception childbearing potential use highly study dose agree months fcbp females childbearing pregnancy potential agree testing ongoing practice contraception dose study contraception adequate days use participants potential childbearing method partner female potential childbearing contraception use effective vasectomy agree men study men duration agree contraception participation adequate pregnant use completion contraception childbearing women potential men adequate use agree practice study bearing child potential contraception use women effective agree study men