- If of childbearing potential, must be practicing an acceptable non-hormonal, method of birth control until the end of the study (Exit/Early Termination). Such methods include but are not limited to: Sexual abstinence; Male or female condom in combination with spermicidal foam/gel/cream/ suppository; Vasectomized or female partner; Diaphragm/cervical cap with spermicide; Bilateral tubal ligation sterilization at least 6 months before the screening visit, or an ESSURE or ADIANA procedure with an hysterosalpingography confirmation test at least 6 months before the screening visit; Copper intrauterine device.