 - Females must be non-pregnant and non-lactating, and either surgically sterile e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy or post-menopausal for 12 months. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of Study Drug. 