 - If female, is nonlactating, has a negative urine pregnancy test result, and does not plan on becoming pregnant during the study, or not of childbearing potential hysterectomy or tubal ligation at least 6 months prior to randomization or post-menopausal for 1 year; if of childbearing potential including peri-menopausal women who have had a menstrual period within 1 year must practice or be willing to continue to practice appropriate birth control such as implants, injectables, oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner during the entire study duration. 