 - If procreative potential male or female, willingness to use effective contraceptive methods for the duration of treatment and continuing for 2 months after the last dose. Subjects of procreative potential are defined as any fertile male, or any female who has experienced menarche and who is not postmenopausal defined as age-related amenorrhea 12 months or who has not undergone successful surgical sterilization hysterectomy or bilateral oophorectomy 