Acknowledgement
Not applicable.
Funding
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this Article: The study was supported by an investigator-initiated research grant from Novartis Healthcare A/S who also provided the study drug.
Availability of Data and Materials
Qualified researchers can request access to patient-level data and related study documents, including the study protocol. Patient-level data will be de-identified and study documents will be redacted to protect the privacy of trial participants.
Author’s Contributions
Håkan Ashina: Study concept and design, acquisition of data, analysis (including statistical analyses) and interpretation, drafting the manuscript.
Afrim Iljazi: Acquisition of data and critical revision of the manuscript for important intellectual content.
Haidar Muhsen Al-Khazali: Acquisition of data and critical revision of the manuscript for important intellectual content.
Anna Kristina Eigenbrodt: Acquisition of data and critical revision of the manuscript for important intellectual content.
Eigil Lindekilde Larsen: Acquisition of data and critical revision of the manuscript for important intellectual content.
Amalie Middelboe Andersen: Acquisition of data and critical revision of the manuscript for important intellectual content.
Kevin John Hansen: Acquisition of data and critical revision of the manuscript for important intellectual content.
Karoline Bendix Bräuner: Acquisition of data and critical revision of the manuscript for important intellectual content.
Thomas Mørch-Jessen: Acquisition of data and critical revision of the manuscript for important intellectual content.
Basit Chaudhry: Acquisition of data and critical revision of the manuscript for important intellectual content.
Sonja Antic: Critical revision of the manuscript for important intellectual content.
Casper Emil Christensen: Analysis (including statistical analyses) and interpretation, critical revision of the manuscript for important intellectual content.
Faisal Mohammad Amin: Critical revision of the manuscript for important intellectual content.
Messoud Ashina: Study concept and design, critical revision of the manuscript for important intellectual content.
Henrik Winter Schytz: Study concept and design, critical revision of the manuscript for important intellectual content, supervision.
Ethics Approval and Consent to Participate
Informed written consent was obtained from each patient before conducting any study-related procedures. The study protocol was reviewed by the Regional Health Research Ethics Committee of the Capital Region of Denmark (identifier: H-18050498).
Consent for Publication
Not applicable.
Competing Interests
The authors declared the following potential conflicts of interest with respect to the research, authorship and/or publication of this article: Dr. Casper Emil Christensen has lectured and been a scientific advisor for Teva. Dr. Messoud Ashina has received personal fees from Alder BioPharmaceuticals, Allergan, Amgen, Eli Lilly, Novartis, and Teva. Dr. Messoud Ashina has been or currently is a principal investigator on clinical trials for Alder, Amgen, electroCore, Novartis, and Teva. Dr. Messoud Ashina also serves as an Associate Editor of Cephalalgia, Associate Editor of Headache, and Co-Editor of the Journal of Headache and Pain. Dr. Messoud Ashina reports research grants from Lundbeck Foundation, Novo Nordisk Foundation, and Research Foundation of the Capital Region of Denmark. Dr. Faisal Mohammad Amin has received personal fees from Eli Lilly, Novartis and Teva. Dr. Faisal Mohammad Amin is currently a principal investigator on clinical trials for Novartis and Teva. Dr. Faisal Mohammad Amin also serves as an Associate Editor of Headache Medicine. Dr. Henrik Winther Schytz has received speaking fees from Novartis and Teva. The other authors declare no conflicts of interest.