 2. Female subjects must be nonpregnant, nonlactating, and have a negative serum pregnancy test before enrollment in the study. Female subjects of childbearing potential including perimenopausal women who have had menstrual bleeding within 1 year must be using appropriate birth control abstinence andor barrier methods andor oral, injectable, or implantable hormonal contraceptives during the entire duration of the study. Women are considered of non-childbearing potential if they are menopausal last menstrual period greater than 12 months before Check in and a serum follicle stimulating hormone level greater than 40 mIUmL or have been surgically sterilized documented hysterectomy, tubal ligation, or bilateral oophorectomy at least 6 weeks before Check in. 