 11. Females of childbearing potential defined as women not surgically sterilized and between menarche and 1 year post-menopause must test negative for pregnancy at Visit 1 based on an urinary pregnancy test and agree to use a reliable method of birth control e.g., oral contraceptives, a reliable barrier method of birth control like diaphragms, intrauterine devices; partner with vasectomy or abstinence during the study. 