 - Women of child-bearing potential without reliable contraception unless they meet the following criteria: postmenopausal 12 months of natural amenorrhea;postoperation status 6 weeks after surgical bilateral oophorectomy with or without hysterectomy;use of highly effective birth control method defined as one which results in a low failure rate i.e. less than 1 per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomized partner 