 - A female subject is eligible to participate if: she is of child-bearing potential and is abstinent or agrees to use one of the contraception methods for an appropriate period of time as determined by the product label or investigator prior to the start of dosing to sufficiently minimize the chance of pregnancy at that point or She must agree to use contraception until the follow-up visit i.e. until follow-up visit is complete or she is on hormone replacement therapy HRT and whose menopausal status is in doubt will be required to use one of the contraception methods 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 2-4 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 or she is confirmed postmenopausal or permanently sterilised example e.g. tubal occlusion, tubal ligation, hysterectomy, bilateral salpingectomy. 