Diener, Hans-Christoph
Donoghue, Stephen
Gaul, Charly
Holle-Lee, Dagny
Jöckel, Karl-Heinz
Mian, Alec
Schröder, Bernadette
Kühl, Tobias
Funding for this research was provided by:
Deutsche Forschungsgemeinschaft (407181137)
Universitätsklinikum Essen
Article History
Received: 12 November 2021
Accepted: 23 April 2022
First Online: 11 May 2022
Declarations
:
: The conduct of this study will be in accordance with the recommendations for physicians involved in research on human subjects adopted by the 18th World Medical Assembly, Helsinki 1964, and later revisions. This trial protocol has been approved by the central ethics committee of the University of Duisburg-Essen (21-10099-BO). All participating sites have to obtain an individual ethics approval for their respective site prior to initiation. Written informed consent will be obtained from all patients prior to enrollment and all trial-related procedures.
: The trial information brochure, the consent form for trial participation and data protection, and insurance terms and conditions and policies will be given to participating patients. The consent form is available upon request.
: HCD received honoraria for advisory boards or oral presentations from Ipsen, Lilly, Lundbeck, and Teva. HCD serves on the editorial boards of <i>Cephalalgia</i> and <i>Lancet Neurology</i>. HCD is a member of the Clinical Trials Committee of the IHS.CG has received honoraria for consulting and lectures within the past 3 years from Allergan Pharma, Lilly, Novartis Pharma, Hormosan Pharma, Grünenthal, Sanofi-Aventis, Weber & Weber, Lundbeck, Perfood, and TEVA. His research is supported by a grant of the German Research Foundation (DFG). He does not hold any stocks of pharmaceutical companies. He is honorary secretary of the German Migraine and Headache Society.SD worked as a consultant for Curelator Inc. and received cash and stock options in compensation.AM worked as a consultant for Curelator Inc. and received stock options in compensation.The other authors declare that they have no competing interests.