9. Female subjects who are of non-child bearing potential defined as females who are either post menopausal [i.e. 1 year of natural (spontaneous) amenorrhea or break-through bleeding together with follicle stimulating hormone (FSH) confirmation of post-menopausal state at screening)] or surgically sterilized [hysterectomy, tubal occlusion, bilateral oophorectomy or bilateral salpingectomy]. FSH is required to document post-menopausal status in women <55 years of age or in women >55 with < 2 years since last menstrual period. FSH is not required for women >55 with >2 years since last menstrual period.