Study Flow-chart.
Of the 30 planned patients, only 12 patients were ultimately enrolled (The trial was conducted in accordance to Good Clinical Practice guidelines (ICH-GCP) and the Declaration of Helsinki. All study procedures were approved by the German Federal Institute for Drug Safety and the German Federal Office for Radiation Protection as well as the local ethics committees of all study centers. The Institute of Biometry and Medical Informatics of the University Hospital Magdeburg provided biometrical support for the RCT. Independent and steady monitoring was provided by the coordination center for clinical studies of the University of Magdeburg and by an external data safety and monitoring board.