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Article History

Received: 9 February 2024

Accepted: 19 August 2024

First Online: 6 September 2024

Declarations

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: All patients give their oral and written informed consent before inclusion.The study has been approved by the Danish Medicines Agency, the regional Scientific Committee and the Danish Data Protection Agency. The project management group holds monthly meetings to review trial conduct; the trial steering group meets every 6 months or more often as required. The study does not have a data monitoring committee, as the intervention was considered low-risk. The associated Good Clinical Practice (GCP) unit perform quarterly on-site monitoring visits and have full access to all original patient documentation. The study adheres to the General Data Protection Regulation (GDPR) and the Data Protection Act.The study has EudraCT registration number 2021–001315-24 and is registered at ClinicalTrials.gov (study identifier: NCT05067153).The study is monitored by the Good Clinical Practice (GCP) Unit and conducted in accordance with the Declaration of Helsinki and applicable local regulatory requirements. The protocol manuscript adheres to the Standard Protocol Items: Recommendation for Interventional Trials (SPIRIT) guidelines (Supplementary Material 1).There was no patient or public involvement in the study conceptualisation.

: The protocol does not contain any pilot data and references only previously published data.

: TDC has been on the speaker bureaus for AstraZeneca, Boehringer-Ingelheim, Pfizer, Roche Diagnostics, Takeda, Merck Sharp & Dohme (MSD), Bristol-Myers Squibb, Chiesi Pharma AB and GlaxoSmithKline and on Advisory Boards for Bayer and Merck Sharp & Dohme (MSD), AstraZeneca and Sanofi.Other authors: None declared.