4.1.13 Female subjects who are not of reproductive potential [i.e., women who have been post-menopausal for at least 24 consecutive months or women who have undergone surgical sterilization (e.g., hysterectomy, tubal ligation, or bilateral oophorectomy)] are eligible without requiring the use of a contraceptive. Acceptable documentation of sterilization, other contraception methods, menopause and reproductive potential is patient-reported history at any time prior to screening.