2. Non-childbearing potential, defined as females with a documented history of a clinically recognized procedure (e.g. hysterectomy, tubal ligation, bilateral salpingo-/oophorectomy) ; or postmenopausal defined as 12 months of spontaneous amenorrhea with follicle-stimulating hormone (FSH) >40 MlU/mL). Females on hormone replacement therapy (HRT) will be required to use one of the contraception methods in Inclusion criteria 8a or must discontinue HRT to allow confirmation of post-menopausal status prior to being enrolled in the study. Following confirmation of their post-menopausal status, they can resume HRT during the study and will not be required to use contraception.