 - Note: Female subjects of reproductive potential is defined as girls who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months e.g. who have had menses within the preceding 24 months, or have not undergone a sterilization procedure hysterectomy, bilateral oophorectomy or salpingotomy. If the female subject is not of reproductive potential, she is eligible without requiring contraception. 