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The study was conducted in accordance with the Good Clinical Practice guidelines and with the provisions of the Declaration of Helsinki (October 9th 2004).","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"The patients have signed consent for the use of anonymized patient data for research purposes.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"IMvO has received grants, personal fees and non-financial support from Astellas; grants and personal fees from Janssen-Cilag; grants and personal fees from Bayer and personal fees from Sanofi (all outside the submitted work). NM reports personal fees from Bayer, grants and personal fees from Jansen-Cilag, personal fees from Merck Sharp & Dohme, grants and personal fees from Roche, grants and personal fees from Astellas, grants and personal fees from Sanofi (all outside the submitted work). JAW reports personal fees from Sanofi, Merck Sharp & Dohme, Bristol-Myers Squibb and Roche (all outside the submitted work). MB is employed as a Project Manager R&D at Miltenyi Biotec GmbH. KP is employed as a Senior Clinical Project Manager at Miltenyi Biotec GmbH. MG has received grants from Astellas and Sanofi, personal fees from Boehringer Ingelheim, Sanofi and Sandoz (all outside the submitted work). JOB is an advisor for SPL Medical and Soteria Medical. WRG reports personal fees from Bristol-Myers Squibb, Merck Sharp & Dohme, Janssen-Cilag, Bayer, Astellas, Bavarian Nordic, Sanofi, Amgen, Curevac, IQVIA, Dendreon, Morphosys, ORCA Pharmaceuticals and Sotio (all outside the submitted work).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"302"}}