Clinical outcome assessment
Clinical outcome assessment at 90 days was performed by study investigators (assessors) who were not directly involved with acute treatment of the patient and who were unaware of treatment assignment. Patients were instructed not to discuss their initial hospitalization and treatment. Each assessor, as the final act of blinded assessment, guessed whether they believed the subject was in the intervention group or control group at the end of outcome assessment. In addition, they indicated how sure they were of their answer and listed items that their guess was based upon. They were not specifically asked if patients or proxies inadvertently mentioned information about the procedure. However, as this is a protocol violation, this should have been reported to the trial coordinators. The questionnaire is shown in 