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The sponsor was involved in the trial design and implementation, and data collection, analysis, interpretation, writing the trial report and reviewing this manuscript. All authors had final responsibility for the decision to submit for publication.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"YB is an employee of Staburo GmbH. MD, SM, CRF and YS are employees of Boehringer Ingelheim.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"To ensure independent interpretation of clinical study results and to enable authors to fulfil their role and obligations under the International Committee of Medical Journal Editors criteria, Boehringer Ingelheim grants all external authors access to clinical study data pertinent to the development of the publication. In adherence with the Boehringer Ingelheim Policy on Transparency and Publication of Clinical Study Data, scientific and medical researchers can request access to clinical study data when it becomes available on\u00a0  Vivli - Center for Global Clinical Research Data, and earliest after publication of the primary manuscript in a peer-reviewed journal, regulatory activities are complete, and other criteria are met. Please visit\u00a0Medical & Clinical Trials | Clinical Research | MyStudyWindow  for further information.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Before the start of the trial, all protocols and required documents were reviewed and approved by the independent ethics committee of the trial centre (Ethikkommission an der Technischen Universit\u00e4t Dresden, Dresden, Germany) and relevant local authorities (Bundesinstitut f\u00fcr Arzneimittel und Medizinprodukte, BfARM, Bonn, Germany); EU CT number: 2022-500050-42-00. 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