 Women of childbearing potential must test negative for pregnancy and agree to use birth control measures that are highly effective. Highly effective methods are defined as those that result in a low failure rate i.e. less that 1 percent per year abstinence when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices IUDs, sexual abstinence, or a vasectomized partner. Likewise, sexually active men must also use appropriate methods of birth control e.g., abstinence, barrier methods with spermicide, or have had surgical sterilization such as vasectomy. 