- Have had a previous traumatic brain injury (more than 1 year and less than 5 years)
prior to the screening visit.
- Have an Extended Glasgow Outcome Scale (GOS-E) more than or equal to 5.
- Active systemic malignancy or active intracranial tumor. A successfully treated tumor
or malignancy is not an exclusion criterion if the patient has not had active disease
for 5 years and is not currently receiving maintenance chemotherapy, (except for basal
cell skin cancers.
- Receiving treatment with prednisolone in doses above 10 mg/day or treatment with other
oral glucocorticosteroids above replacement doses is not permitted throughout the
study. Topical and inhaled corticosteroids are permitted.