- Female patients must either be of non-reproductive potential (i.e. post-menopausal by history of age ≥60 years old and no menses for 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test (β-human chorionic gonadotropin (HCG)) at the Screening visit. (If Screening visit pregnancy test was completed within 7 days of first treatment visit it does not need to be repeated. Patients with a negative pregnancy test at Screening beyond 7 days prior to treatment, but who otherwise meet all other criteria, may be registered to study but must have a repeat negative serum pregnancy test within 7 days of treatment and such testing may be done on day of first treatment prior to administration).