Institutional Review Board Statement
Ethikkommission der Universität zu Lübeck, Ethik-Kommission der Medizinischen
The clinical studies were conducted in accordance with the Declaration of Helsinki and approved by the institutional review board (IRB) or institutional ethics committee (IEC) at each participating site (United States and Canada central IRB/IEC: Advarra; United States local IRBs/IECs: Penn State College of Medicine IRB, The Rockefeller University IRB; Canada local IRB/IEC: Biomedical Research Ethics Board; Denmark central IRB/IEC: Den Regionale Videnskabsetiske Komité; Germany central IRB/IEC: Ethik-Kommission der Medizinischen Fakultätder Ruhr-Universität Bochum; Germany local IRBs/IECs: Ethik-Kommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität Münster, Ethikkommission der Universität zu Lübeck).