 Note: All female subjects are considered of childbearing potential unless postmenopausal or surgically sterilized and 3 months have passed since sterilization procedure. Postmenopausal is defined as amenorrhea for 12 months without an alternative medical cause. Permanent female sterilization procedures include tubal ligation, bilateral salpingectomy, hysterectomy, bilateral oophorectomy, or successful Essure placement. 