Indrekvam, Kari http://orcid.org/0000-0002-9636-9712
Myklebust, Tor Åge
Austevoll, Ivar Magne
Hermansen, Erland
Banitalebi, Hasan
Bånerud, Ingrid Fjeldheim
Weber, Clemens
Brisby, Helena
Brox, Jens Ivar
Hellum, Christian
Storheim, Kjersti
Funding for this research was provided by:
University of Bergen
Article History
Received: 24 April 2024
Revised: 24 April 2024
Accepted: 30 July 2024
First Online: 13 August 2024
Declarations
:
: The Norwegian Committees for Medical and Health Research Ethics approved the trials (NORDTEN-SST trial and NORDSTEN-OC; 2011/2034, NORDSTEN-DS trial; 2013/366). Data protection was approved by the Norwegian Data Inspectorate and data are stored at “Services for sensitive data” (TSD) hosted by the University of Oslo, to allow secure data sharing between researchers. Informed consent was obtained from patients after oral and written information. The study was performed according to the Helsinki Declaration and registered at ClinicalTrials.gov under the following identifiers; SST: NCT02007083 10/12/2013 / DS: NCT02051374 31/01/2014 / OC: NCT03562936 20/06/2018. The trial is monitored according to requirements of the Good Clinical Practice (GCP) guidelines.
: The authors declare that they have no financial or non-financial that are directly or indirectly related to the work submitted for publication.