The study will be monitored by an independent external Data Safety Monitoring Board (DSMB)/ Data Monitoring Committee (DMB). The DSMB will provide recommendations to the Oversight Committee. The Oversight Committee (consisting of the sponsor and coordinating investigator Dr. med. Hans Jaeger and principal investigator Prof. Johannes Bogner) will provide the overall scientific direction for the trial, and will receive and decide on any recommendations made by the DSMB. The Oversight Committee must approve all scientific reports concerning the main findings of the trial. The membership, procedures, functions and responsibilities of the Oversight Committee and DSMB will be identified in the New Era DSMB Charter.