The GOS assesses mortality and disability in traumatic brain injury (TBI) patients according to the designation: Good Recovery, Moderate Disability, Severe Disability, Vegetative State or Dead.

Only participants with data for this outcome are included. Missing values are first imputed by carrying forward the Month 3 GOS assessment. If a subject has neither the 3 nor the 6 month GOS, the missing value is imputed using the proportional odds model.

The mortality rate at one month will be compared between the two treatment groups.

P-value population size is based on the number of subjects with status = alive or dead, month 6 within the mITT population.

The mortality rate at six months will be compared between the two treatment groups.

P-value population size is based on the number of subjects with status = alive or dead, month 6 within the mITT population.

The GOS assesses the mortality and disability in traumatic brain injury patients according to the designation: Good Recovery, Moderate Disability, Severe Disability, Vegetative State, or Dead.

The GOS-E assessment of mortality and disability in TBI patients extends the original five GOS categories of functional outcome to eight categories:

• Dead
• Vegetative State
• Lower Severe Disability
• Upper Severe Disability
• Lower Moderate Disability
• Upper Moderate Disability
• Lower Good Recovery
• Upper Good Recovery

Number analyzed (591 for BHR-100 and 588 for placebo) is as listed in the clinical study report. The number analyzed was not modified per time frame and outcome, rather 591 and 588 are included.

The Short Form (36) Health Survey (SF-36) is a validated survey of patient health consisting of eight scaled scores which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, role physical, role emotional, role mental and mental health. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment. The 8 scales can also be further summarized to provide a summary score for physical health and a summary score for mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Only participants with data for these parameters have been included.

Cerebral Perfusion Pressure (CPP) levels are presented according to clinically significant cut-off values. CPP was calculated from intracranial pressures and mean arterial pressures measured from Day through Day 6 after initiation of study medication, if an ICP monitor was in place. Specific therapies received during Days 1-6 are summarized according to the Therapeutic Intensity Level (TIL) by treatment group, as maximum level of therapy administered to the subject.

Only participants with data for these parameters have been included.