Larsen, Lars Bruun http://orcid.org/0000-0001-9120-4751
Sonderlund, Anders Larrabee
Sondergaard, Jens
Thomsen, Janus Laust
Halling, Anders
Hvidt, Niels Christian
Hvidt, Elisabeth Assing
Mønsted, Troels
Pedersen, Line Bjornskov
Roos, Ewa M.
Pedersen, Pia Vivian
Thilsing, Trine
Funding for this research was provided by:
Sundhedsstyrelsen (j.nr. 1-1010-116/26/KAD)
Region of Southern Denmark - Regional committee for Quality and Education in General Practice (j.nr. 15/10562)
Article History
Received: 23 December 2016
Accepted: 15 July 2018
First Online: 21 July 2018
Ethics approval and consent to participate
: The study adheres to the SPIRIT guidelines and has been approved by the Danish Data Protection Agency (J.nr 2015–57-0008) and registered at Clinical Trial Gov (Unique Protocol ID: TOFpilot2016). According to Danish regulations (Act on Research Ethics Review of Health Research Projects (section 14,2)) this study does not need approval from a health research ethics committee as no research on human tissue or other biological material is performed. The study complies with the Helsinki declaration with informed consent to study participation and to disclosure of data from the GPs EPR obtained from all participants before enrolment. Participants were asked to read the information and electronically sign the consent form that was supplemented with short videos of the principal investigator and a GP describing the purpose of the study and the intervention. Before linking project data and national registers from Statistics Denmark participants will be pseudomized. Data management and data analysis of quantitative data will be performed on secure servers at Statistics Denmark.
: Not applicable.
: The authors declare that they have no competing interests.
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