The trial is monitored by a Data Safety Monitoring Board (DSMB).

DSMB members:

• Dr. Rupert Pearse, William Harvey Research Institute, London, U.K.
• Prof. Dr. med. Rolf Rossaint, University Hospital Aachen, Germany

All adverse events will be reported via the SAE manager to the DSMB.

SAE manager:

Sabrine Hemmes, Academic Medical Center, University of Amsterdam, The Netherlands

The independent DSMB watches over the ethics of conducting the study in accordance with the Declaration of Helsinki, monitors patient safety and reviews safety issues as the study progresses. The primary mandate of the DSMB is to protect patient safety.

The SAE manager assesses the events and reports all related or possibly related events and all unexpected events to the DSMB for review.

The DSMB will review unblinded results on request. If adverse events of a particularly serious type are more common in the experimental arm compared to the control arm, then the DSMB may recommend termination of the study based on the evaluation of these results. This evaluation has to be made in consideration of risk/benefit.