 20. A female participant must meet one of the following criteria: a no reproductive potential due to menopause one year without menses, hysterectomy, bilateral oophorectomy, or tubal ligation; b agrees to consistently practice contraception at least 30 days prior to enrollment and throughout the duration of the study by means of IUD, hormone-based therapy e.g., contraceptive pills, Norplant Registered Trademark, or Depo-Provera Registered Trademark or other FDA-licensed methods. 