Updates are available Correction dated 2024-04-04

Article History

Received: 23 June 2023

Accepted: 22 January 2024

First Online: 21 March 2024

Change Date: 4 April 2024

Change Type: Correction

Change Details: A Correction to this paper has been published:

Change Details: https://0-doi-org.brum.beds.ac.uk/10.1186/s13063-024-08075-z

Declarations

:

: <i>Research ethics approval</i>This study has been granted approval by the Research Ethics Committee (REC) at SDU.<i>Protocol amendments</i>The following is the plan for communicating important protocol amendments:1. Identify the need for a protocol amendment: When a need for a protocol amendment is identified by the research team.2. Develop a plan for the amendment: The research team will develop a detailed plan for the protocol amendment, including the rationale for the change, the impact on study procedures and outcomes, and any necessary revisions to the informed consent process.3. Submit the amendment to the appropriate review board: The amendment will be submitted to the REC at SDU.4. Communicate the amendment to all stakeholders: Once the amendment has been approved, the changes will be communicated to all stakeholders, including study participants, investigators, and research staff. This may involve, but not limited to, meetings and email updates.5. Update study documents: All research documents, including the protocol, informed consent form, and study reports, will be updated to reflect the changes made in the amendment.By following this plan, the research teams can effectively communicate important protocol amendments to all stakeholders, ensuring that the study is conducted in an ethical and safe manner.

: Not applicable.

: The authors declare that they have no competing interests. Study investigators declare no personal or financial interests that may potentially influence the content or interpretation of the findings presented.