8. Cont. form #7. Female patients must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: － Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 consecutive months following cessation of all exogenous hormonal treatments － Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation. Male partners should be instructed to use contraception during the study period.