 - A female subject is eligible to participate if she is of: Child-bearing potential and is abstinent or agrees to use the contraception methods listed in Protocol for an appropriate period of time as determined by the product label or investigator prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until the follow up visit i.e. until after the follow up visit is complete; Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea in questionable cases a blood sample with simultaneous follicle stimulating hormone FSH 40 million international units MlUmilliliter ml and estradiol 40 picograms pgml 147 pmolL is confirmatory Females on hormone replacement therapy HRT and whose menopausal status is in doubt will be required to use the contraception methods listed in Protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status prior to study enrollment. For most forms of HRT, at least 2 to 4 weeks should elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method. 