 9. All women of childbearing potential A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months i.e., who has had menses at any time in the preceding 24 consecutive months and male participants must practice effective contraception abstinence, oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner throughout the study. 