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The study protocol and its amendments were approved by the Institutional Review Board or Independent Ethics Committee for each study site before the start of the study\u00a0(see Supplementary Information in reference [\n                      \n                      ] for details).","order":1,"name":"Ethics","label":"Ethical approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Written informed consent was obtained from all individual participants included in the study.","order":2,"name":"Ethics","label":"Informed consent","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"LS, SF, and IT report receiving consulting and lecture fees from Gedeon Richter; JK, NJ, KH-K, and EJ are employees at Gedeon Richter; DP, JR, JS, OV, and RNL have no conflicts of interest to disclose.","order":3,"name":"Ethics","label":"Conflicts of interest","group":{"name":"EthicsHeading","label":"Declarations"}}]}}