Issa, Zaid http://orcid.org/0000-0003-0323-9183
Rasmussen, Jeppe Vejlgaard
Petersen, John Kloth
Schantz, Kim
Brorson, Stig
Funding for this research was provided by:
Research foundation for health research of The Zealand Region (18-000494)
Article History
Received: 19 March 2019
Accepted: 20 June 2019
First Online: 12 July 2019
Ethics approval and consent to participate
: The study will be conducted according to the ethical principles outlined in the Declaration of Helsinki [CitationRef removed]. Each patient who wants to be part of the trial will be informed about the trial orally and in writing. Those who decide to join the trial will be asked to sign an informed consent form. The Scientific Ethics Committee in Region Zealand, Denmark has approved this study protocol (approval reference number SJ-750), including the informed consent form and patient information sheets (Additional file InternalRef removed). We will, at all times, respect the General Data Protection Regulation and Data Protection Act. The processing of personal data has been approved by the Danish Data Protection Agency (jr.no. REG-106-2018).As participants in the trial, patients are covered by the insurance policies that apply to ordinary treatment in the hospital; they may complain and receive compensation following the rules in the Act on Complaints and Compensation in the Health Services. All participants will be informed about the possibility of access to the trial protocol by freedom of information act.
: Not applicable.
: The authors declare that they have no competing interests.