1. Males and females ≥18 years of age at the Screening Visit. NOTE: Eligible females were postmenopausal or surgically sterile, or, if of child bearing potential, were not pregnant or nursing, and they agreed to not become pregnant during the study by using acceptable means of contraception for at least 1 month before and 1 month after dosing, including any of the following: hormonal contraceptives (oral, injectable, implantable), effective barrier methods (e.g., condoms with spermicide), intrauterine device (IUD), lifestyle with a personal choice of abstinence, non-heterosexual lifestyle, or in a strictly monogamous relationship with a partner who has had a vasectomy.