 1. Male or female. Women of childbearing potential must have a negative serum or urine human chorionic gonadotropin assay prior to surgery, and be willing to continue to use effective means of birth control for at least 180 days following surgery. Medically acceptable contraceptives include: 1 surgical sterilization such as a tubal ligation or hysterectomy, 2 approved hormonal contraceptives such as birth control pills, patches, implants or injections, 3 barrier methods such as a condom or diaphragm used with a spermicide, or 4 an intrauterine device IUD. Contraceptive measures such as Plan BTM, sold for emergency use after unprotected sex, are not acceptable methods for routine use. 