 - Women of childbearing potential with a negative urine pregnancy test at Screening who were not breastfeeding, did not plan to become pregnant during the study, and agreed to use dual methods of birth control during the study i.e., 2 of the following: diaphragm or cervical cap with spermicide, intrauterine device IUD hormonal contraceptives stable for at least 3 months prior to Screening, male partner using condom with spermicide from Day 1 until 60 days following the administration of study drug; or female subjects of non-childbearing potential were either surgically sterile hysterectomy, bilateral oophorectomy, or bilateral tubal ligation or 1 year post-menopausal with a follicle-stimulating hormone FSH in the post menopausal range post-menopausal taking hormone replacement therapy stable for at least 3 months prior to Screening did not require an FSH level; 