3. For female subjects: Surgically sterile or menopausal (at least 1 year absence of vaginal bleeding or spotting) and as confirmed by follicle-stimulating hormone (FSH) ≥ 40 mIU/mL. Females of childbearing age/potential may be included provided that they are using medically acceptable methods of birth control for 1 month prior to and for the duration of the study and for 3 months thereafter. Dual methods must be used, for example a hormonal method used with a barrier method.