Acknowledgements
The Authors thank the sponsor of this clinical trial the Nordmark Pharma GmbH represented by Dr. Jörn Tonne for funding and supply of drugs, as well as his team of Clinical Development, especially Dr. Kristin Forßmann followed by Dr. Winrich Rauschning. For collaboration with conception of the clinical study we thank Dr. Klaus Rübsamen. Moreover, we acknowledge Dr. Martina Jordan and Dr. Gudrun Cimander (ClinSupport GmbH) for excellent support and monitoring during the entire study, Alexander Gissler of ProjectPharm for support with regulatory activities and monitoring of the study sites located in Czech Republic, and Dr. Christoph Ortland of Forschungsdock GmbH for support of project management activities. With regard to data management and biostatistics activities, we acknowledge the Medizinisches Wirtschaftsinstitut GmbH, represented by Dr. Dirk Osterkorn followed by X-act Cologne Clinical Research GmbH, among others Dieter Wohltmann and Andreas Bachinger.