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The study was performed in compliance with current standards of International Conference for Harmonization\u2014Good Clinical Practice and the WHO Declaration of Helsinki and in accordance with the Medical Research Involving Human Subjects Act.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All patients received written information and an explanation of the study and signed written informed consent before participation in the trial. The informed consent procedure was conducted compliant with current standards of International Conference for Harmonization\u2014Good Clinical Practice.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Consent for publication was not applicable since all collected data were anonymised before storage, analysis and publication.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The datasets generated and\/or analysed during the current study are available from the corresponding author on reasonable request.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data availability"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"MV, VW, MK, JB and SM contributed to the protocol development and initiation of the trial. MV, VW and SM contributed to the conduct of the clinical trial. 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