 3. Female subjects were postmenopausal for at least 1 year, had a hysterectomy, or had a tubal ligation; or, if of childbearing potential, agreed to use an approved method of birth control throughout the study i.e., oralsystemic contraceptives, intrauterine device IUD, or spermicide in combination with a barrier method of contraception, were abstinent, or were in a monogamous relationship with a vasectomized partner; and had a negative urine pregnancy test at the screening visit. 