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Article History

Received: 14 January 2021

Accepted: 19 January 2021

First Online: 26 February 2021

Ethics approval and consent to participate

: This study is carried out in accordance with the study protocol, the Helsinki Declaration, and good clinical practice. The study was approved by the Danish Data Protection Agency and the Regional Committee for Medical and Health Research Ethics for the Central Denmark Region, reference # 1–10–72-68-20. All participants will be given written and verbal information about the study, and are free to withdraw from the study at any time for any reason. Written informed consent will be received from all study participants. All data will collected and stored on secure servers, in accordance with the Danish Data Protection Act (Law # 502 of May 12 2018), and the European General Data Protection Regulation (2016/679) of the European Parliament and of the Council. The Danish Data Protection Agency has approved all data collection procedures and will continue to monitor the data collection and storage throughout the project.

: No details, images or video material relating to an individual person, participant or treatment provider, will be published in relation to the study.

: The authors declare that they have no competing interests, financial or otherwise, in relation to this trial.