 - Negative pregnancy test or post-menopausal. Women with childbearing potential i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile must be using a highly effective method of contraception i.e. combined estrogen and progestogen containing hormonal progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence 