 7. Pregnancy, breastfeeding, and premenopausal females or males not using adequate contraception; medically acceptable birth control methods for this study include: 1 Abstinence no sexual intercourse; 2 Intrauterine device IUD; 3 Diaphragm with spermicide; 4 Condom with spermicide; and 5 Oral contraceptives birth control pills condomdiaphragm with spermicide. 