- Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must be willing to use a highly effective method of contraception. Not engaging in sexual activity for the total duration of the study and the drug washout period is an acceptable practice; however, occasional abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Male subjects must be willing to refrain from sperm donation throughout these periods. Female partners of a male subject must use a highly effective method of contraception throughout these periods.