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Hans-Heinrich Henneicke-von Zepelin and Oliver Wiedow are employees of the sponsor of this clinical trial.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study was conducted in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects adopted by the General Assembly of the World Medical Association [\n                      \n                      ]. The planning and conduct of this clinical trial followed the national laws of Germany, the principles and guidelines for good clinical practice (GCP) laid down in Directives 2001\/20\/EC [\n                      \n                      ] and 2005\/28\/EC [\n                      \n                      ] of the European Parliament and the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice [\n                      \n                      ]. The trial protocol and other study-relevant documents were submitted for review and approved by the Ethics Commission at the RWTH Aachen Faculty of Medicine in Aachen, Germany (EK 197\/22, September 2022). The protocol was also reviewed and approved by the national competent authority in Germany (Bundesinstitut f\u00fcr Arzneimittel und Medizinprodukte, BfArM), finally in February 2023 (trial registration: EudraCT 2022\u2013000714-33, DRKS00031463) [\n                      \n                      ,\n                      \n                      ].","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}]}}