The second step will be to compare treatment groups with respect to suspected important covariates, specifically patient age, gender, cause and type of brain injury, presence or absence of intracranial mass lesions, presence/absence of extracranial trauma, presence/absence of premorbid confounders (e.g., alcohol intoxication, alcoholism, stroke, etc.), presence/absence of confounding neurological insults (e.g., hypoxemia, hypotension), severity of TBI, and time to initial drug administration. This will assess the balance achieved through randomization. The third step will be to analyze the data according to our specific aims.