Throughout the pilot trial, subjects will be monitored for potential side effects of drug therapy (i.e. hyperglycemia, hypertension unexplained by increases in ICP, unexplained fever, local phlebitis, thromboembolic disease, abnormal vaginal bleeding). The Safety Committee will meet quarterly to review group-specific clinical outcomes and side effects. If they are concerned that one group is doing significantly better (or worse) than the other, they have the authority to break the code and order premature termination of the trial.