 - Women, unless surgically sterile including tubal ligation or at least 2 years post-menopausal, must use an effective method of avoiding pregnancy including oral, injectable, transdermal, or implanted contraceptives, intrauterine device, diaphragm with spermicide, cervical cap, abstinence, and sterile sexual partner in addition to the use of condoms male or female condoms with spermicide from signing of the informed consent through the end of the study. Cessation of birth control after this point should be discussed with a responsible physician. Men, unless surgically sterile, must likewise practice 2 effective methods of birth control condom with spermicide or abstinence and must use such precautions from Study Day 0 through the end of the study; 