 5. Pregnant female as confirmed by an Human chorionic gonadotropin hCG test performed less than 4 weeks before day 1 or breast-feeding female. Female subjects of childbearing potential without adequate contraception, e.g. hysterectomy, bilateral tubal ligation, non-hormonal intrauterine device, total abstinence, double barrier methods, or two years post-menopausal. They must agree to take precautions in order to prevent a pregnancy throughout the entire conduct of the study. 