 9. Patient male or female of reproductive potential must agree to use medically acceptable contraception during the study. NOTE: Medically acceptable contraceptives include: 1 surgical sterilization, 2 approved hormonal contraceptives such as birth control pills, Depo-Provera, or Lupron Depot, 3 barrier methods such as a condom or diaphragm used with a spermicide, or 4 an intrauterine device IUD. 