- Had unprotected sexual intercourse within 30 days before study entry and do not agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double barrier method [such as condom plus diaphragm with spermicide] or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 28 days after study drug discontinuation. Note: Hormonal contraceptives are not allowed.