 - Women of child-bearing potential defined as less than 1 year post-menopausal and not surgically sterile must be practicing abstinence or using two highly effective methods of contraception defined as a method of birth control that result in a low failure rate, i.e., less than 1 per year, such as approved hormonal contraceptives, barrier methods such as a condom or diaphragm used with a spermicide, or an intrauterine device. Subjects must have a negative ß-hCG pregnancy test during the Screening period and negative urine pregnancy test results at all other study visits. 