Vilhelmsen, Frederik http://orcid.org/0000-0002-3958-5937
Nersesjan, Mariam
Andersen, Jakob Hessel
Danker, Jakob Klim
Broeng, Leif
Hägi-Pedersen, Daniel
Mathiesen, Ole
Thybo, Kasper Højgaard
Funding for this research was provided by:
Region of Zealand's Health Sciences Research Fund (No grant number)
Article History
Received: 19 May 2019
Accepted: 18 August 2019
First Online: 28 August 2019
Ethics approval and consent to participate
: The trial was approved by The Danish Medicine Agency, Copenhagen S, Denmark (No. 2016121227, EudraCT-no. 2016–004936-39); the Ethics Committee of the Region of Zealand (Den Videnskabsetiske Komité, Region Sjaelland, Alléen 15, 4180 Soroe, Denmark; February 1st, 2017; file number SJ-602) and the Danish Data Protection Agency (REG-161-2016). The trial was conducted in accordance with the Helsinki-declaration [CitationRef removed], Good Clinical Practice (GCP) guidelines [CitationRef removed] and monitored by the University of Copenhagen GCP unit. All participants gave their written informed consent before trial inclusion. The authors confirm that all ongoing and related trials for this drug/intervention are registered.
: Not Applicable.
: The authors declare that they have no competing interests.