 3. Male or female. All females are required to have a negative human chorionic gonadotropic hCG pregnancy test urine. All females of childbearing potential not surgically sterile, or less than two years post menopausal are required to use an acceptable method of contraception, such as implant, injectable, oral contraceptives with additional barrier contraception, intrauterine device, sexual abstinence, or vasectomized partner, throughout the study. 