Klarskov, Carina Kirstine http://orcid.org/0000-0001-7702-8595
Holm Schultz, Helga
Persson, Frederik
Møller Christensen, Tomas
Almdal, Thomas Peter
Snorgaard, Ole
Bagge Hansen, Katrine
Pedersen-Bjergaard, Ulrik
Lommer Kristensen, Peter
Article History
Received: 10 December 2019
Accepted: 28 May 2020
First Online: 15 June 2020
Ethics approval and consent to participate
: The investigator, project nurse or other trained personnel must ensure that the patient is adequately informed both orally and in writing about the study background, design, potential outcome, advantages and disadvantages for participating. All patients provide written informed consent before initiation of any study procedures. Patients can provide a separate consent for biobank sample collection. The study was approved by the Regional Committee on Biomedical Research and Ethics (H-18046227), the Danish Medicines Agency (2018091559) and the Danish Data Monitoring Board (VD-2018-250, I-suite 6491). The study is registered atExternalRef removed(2018–002640-82). The study is conducted in accordance with the Helsinki Declaration (2002) and the EU Directive on GCP and ICH-GCP guidelines. The study is monitored by the GCP-unit at Copenhagen University Hospital.
: Not applicable.
: CKK: None. HHS: None. TMC: None. KBH: None. TPA reports ownership of shares in NovoNordisk A/S. FP reports having received research grants from Astra Zeneca, lecture fees from Astra Zeneca, MSD, Janssen, Lily, Boehringer Ingelheim, Novo Nordisk, Novartis and being consultant/advisory board member for Astra Zeneca, Bayer, Amgen and MSD. UPB has served on advisory boards for AstraZeneca, Bristol-Myers Squibb, Sanofi-Aventis, Novo Nordisk, and Zealand Pharma and has received lecture fees from AstraZeneca, Bristol-Myers Squibb, Sanofi-Aventis and Novo Nordisk. OS has been a speaker for Boehringer Ingelheim Danmark A/S (2018), Sanofi Danmark and Novartis Healthcare A/S. PLK has received lecture fees from Boehringer Ingelheim and Aztra Zeneca.