Updates are available Correction dated 2021-07-06

Article History

Received: 24 November 2020

Accepted: 23 April 2021

First Online: 16 June 2021

Change Date: 6 July 2021

Change Type: Correction

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

Change Details: https://doi.org/10.1186/s13063-021-05395-2

Declarations

:

: The study is conducted in accordance with the criteria (valid at present) of the Declaration of Helsinki, the ICH-guidelines for Good Clinical Practice, the Memorandum for Safeguarding Good Scientific Practice (German Research Foundation/DFG), the International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS/WHO) and the CONSORT Statement of recommendations for reporting trials. An independent advisory board is established including Patient and Public Involvement (PPI) representatives as well as scientific experts that also review the adherence to the abovementioned guidelines during the entire course of the study.Only subjects will be included in the study who provide written informed consent. Prior participation, all participants will receive information about the study including information on potential risks and benefits and data protection procedures. There are no particular risks involved in taking part in this trial; however, any events will be recorded and reported to the trial’s coordinator and PI.Ethical approval has been obtained from the Ethical Committee of the University Medicine Greifswald (Registry number BB 120/2019) and the Ethical Committee of the University Medicine Rostock (Registry number A2020/0013). The trial is registered at ClinicalTrials.gov (NCT04037501). Any protocol amendments will be communicated to relevant parties (e.g., investigators, REC/IRBs, trial participants, trial registries, journals, regulators).

: Consent for publication of anonymised data will be obtained in the written informed consent.

: The authors declare that they have no competing interests.