 10. All female subjects will be considered to be of child-bearing potential unless they are postmenopausal at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause, or have been sterilized surgically i.e., bilateral tubal ligation greater than or equal to 1 menstrual cycle prior to randomization, or have undergone a hysterectomy andor bilateral oophorectomy. 