 - Nonsterile or premenopausal female subjects must be using a medically accepted method of birth control, that is, oral contraceptive, hormonal implant, medically prescribed intra-uterine device IUD, or depot injectable during the entire study. A female subject who is not currently sexually active must agree and consent to use one of the above-mentioned methods, if she becomes sexually active while participating in the study. A female subject who is not of childbearing potential must have a medical record of being surgically sterile for example, hysterectomy, and tubal ligation, or be at least 1 year postmenopausal. 