Efficacy: To assess the efficacy of the drug on an interim basis, there will be a comparison of the study groups with respect to the endpoints (mortality, duration of coma, ICP-TIL, and neurological status indicators at one month) at the time when 12, 24, and 48 patients have been entered into the trial. Comparisons at these interim points which exceed a z-score of 2.782 (associated p-value of 0.0054) will be considered significant, using the O'Brien-Fleming procedure.