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Authors
Larsen, Lars Bruun https://orcid.org/0000-0001-9120-4751
Sondergaard, Jens
Thomsen, Janus Laust
Halling, Anders
Sønderlund, Anders Larrabee
Christensen, Jeanette Reffstrup
Thilsing, Trine
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Funding
Funding for this research was provided by:
Region Syddanmark (-)
Ministeriet Sundhed Forebyggelse (1-1010-116/26/KAD)
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Article History
Received: 10 September 2018
Accepted: 31 July 2019
First Online: 13 August 2019
Ethics approval and consent to participate
: The study was approved by the Danish Data Protection Agency (J.nr 2015-57-0008) and prospectively 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 were pseudomized. Data management and data analysis of quantitative data was performed on secure servers at Statistics Denmark.
: Not applicable.
: The authors declare that they have no competing interests.
