 10. If female of childbearing potential women who are post-menopausal 1 year, not surgically sterilized, or not abstinent, pregnancy urine test is negative, and agrees to be consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile prior to the female subject entry into the study and is the sole sexual partner for that female subject; any intrauterine device IUD with a documented failure rate of less than 1 per year; oral contraception, or barrier methods, including diaphragm or condom with a spermicide. 