 Acceptable forms of contraception include: established use of oral, injected or implanted hormonal contraceptives; intrauterine device or intrauterine system; barrier methods condoms or diaphragm with additional spermicide; male partners sterilisation with appropriate post-vasectomy documentation of absence of sperm in the ejaculate; true abstinence when this is in line with the preferred and usual lifestyle of the subject; Periodic abstinence e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception. 