 15. Unwillingness or inability to use a highly effective method of birth control by women of childbearing potential. Highly effective methods of birth control are defined as those which result in a low failure rate i.e., less than 1 per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices IUDs, sexual abstinence or vasectomised partner. Barrier methods of contraception are accepted if condom or occlusive cap is used together with spermicides e.g., foam or gel. Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligationsalpingectomy, or post-menopausal for at least two years. 