14. Female patients of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile; e.g. amenorrehic for ≥12 consecutive months without alternative medical cause). Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy (40). If indicated, as per investigator's request, post-menopausal status may be confirmed by follicle-stimulating hormone levels (according to local laboratory ranges).