 - Sexually active females must test negative on urine pregnancy test and must be counseled on an effective method of avoiding pregnancy e.g., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant or Depo-Provera, be surgically sterile, be post-menopause for at least one year, or be monogamous with a sterile sexual partner for at least 15 days prior to dosing with study product and at least 72 hours after their last dose of test drug. 