- Female subjects: Women not of child-bearing potential due to surgical sterilisation(hysterectomy or bilateral oophorectomy or tubal ligation) or postmenopausal as defined by age greater than or equal to 45 years, with an intact uterus, not taken hormones or oral contraceptives for > 1 year, and either: Spontaneous amenorrhoea of >12 months, or Spontaneous amenorrhoea of 6-12 months with a follicle-stimulating hormone (FSH) level of >40 mIU/mL