Eggertsen, Peter Preben http://orcid.org/0000-0003-3890-9976
Palmfeldt, Johan http://orcid.org/0000-0001-5585-639X
Schytz, Henrik Winther http://orcid.org/0000-0002-6262-2986
Hay, Debbie http://orcid.org/0000-0002-9558-5122
Olsen, Rikke Katrine Jentoft http://orcid.org/0000-0003-3470-5589
Nielsen, Jørgen Feldbæk http://orcid.org/0000-0001-5339-171X
Funding for this research was provided by:
Helsefonden
Helga og Peter Kornings Fond
Direktør Emil C. Hertz og Hustru Inger Hertz Fond
Fonden til Lægevidenskabens Fremme
Region Midtjyllands Strategiske Forskningsmidler
The Aarhus County Research Initiative
Aarhus Universitet
Article History
Received: 21 November 2023
Revised: 28 December 2023
Accepted: 29 December 2023
First Online: 17 January 2024
Declarations
:
: H.W.S. has received personal fees from AbbVie, Teva, Lundbeck, Novartis, & Lilly, outside of the submitted work. D.L.H. has received research support from AbbVie, and has acted as an advisor, speaker or consultant for Amgen, Teva and Eli Lilly in the past three years. P.P.E, J.P., R.K.O, and J.F.N. report no conflicts of interests.
: The study was conducted in accordance with the Declaration of Helsinki, and was approved by the Committee of Health Research Ethics of the Central Denmark region (case no. 1-10-72-237-14). All PPCS participants provided written informed consent. Written informed consent was not required from the healthy individuals as it comprised of blood samples from anonymized Danish blood donors all of whom have consented to the use of their anonymized samples for research []. The previously published RCT study (GAIN 1.0) was registered on ClinicalTrials.gov (NCT02337101) in January 2015 and published in 2019 []. In February 2023, before measuring CGRP, we uploaded and registered the hypotheses and a statistical analysis plan for the primary outcome of this study (NCT05812742).