Document is current

Article History

Received: 27 October 2023

Accepted: 20 December 2023

First Online: 18 January 2024

Declarations

:

: Patricia Pozo-Rosich reports honoraria as a consultant and participation in the last 3 years in advisory boards for AbbVie, Amgen, Biohaven, Chiesi, Eli Lilly, Lundbeck, Medscape, Novartis, Pfizer, and Teva Pharmaceuticals; institutional research support from AbbVie, AGAUR, EraNet NEURON, Instituto Investigación Carlos III, International Headache Society, La Caixa Foundation, Novartis, PERIS, RIS3CAT FEDER, and Teva Pharmaceuticals; being a principle investigator for over 50 clinical trials (phases II, III, and IV) for the treatment of migraine and other headaches; education projects with AbbVie, Almirall, Chiesi, Eli Lilly, Lundbeck, Medlink, Medscape, Neurodiem, Novartis, and Teva Pharmaceuticals; participation in the Scientific Advisory Board of Migraine Research Foundation & Lilly Foundation Spain and Honorary Secretary of the International Headache Society; and being an associate editor for <i>Cephalalgia</i>, <i>Headache</i>, <i>The Journal of Headache and Pain</i>, <i>Neurologia</i>, and <i>Frontiers of Neurology</i>, director for headache section of <i>Revista de Neurologia</i>, and editorial advisor for headache section of <i>Revista de Neurologia</i>. Messoud Ashina has received personal fees from AbbVie, Amgen, Eli Lilly, GlaxoSmithKline, Lundbeck, Novartis, Pfizer, and Teva Pharmaceuticals during the conduct of the study; has received research support from Lundbeck Foundation, Novo Nordisk Foundation, and Novartis; and has served as associate editor of <i>Cephalalgia</i>, associate editor of <i>The Journal of Headache and Pain</i>, and associate editor of <i>Brain</i>. Stewart J. Tepper reports research funding from Abbvie, Aeon, Axsome, Cassava, Cognition, Eli Lilly, Inhibikase, Lundbeck, Neurolief, Pfizer, PrecisionMed, Suven, and UCB. He acts as a Consultant and/or on Advisory Boards (honoraria) with Aeon, Abbvie, Alphasights, Amgen, Aruene, Atheneum, Axsome Therapeutics, Becker Pharmaceutical Consulting, ClearView Healthcare Partners, ClickTherapeutics, CoolTech, CRG, Decision Resources, Defined Health, DRG, Eli Lilly, ExpertConnect, FCB Health, Fenix, GLG, Guidepoint Global, Health Advances, Health Science Communications, HMP Communications, Impel, Initiatior Pharma, InteractiveForums, Keyquest, Ki Health Partners, Krog and Partners, Lundbeck, M3 Global Research, Magnolia Innovation, MJH Holdings, Miravo Healthcare, Neurofront Therapeutics, Neurolief, Novartis, P Value Communications, Pain Insights, Palion Medical, Pfizer, Pulmatrix, Putnam Associates, Rehaler, SAI MedPartners, Satsuma, Scilex, Slingshot Insights, Spherix Global Insights, Strategy Inc, Synapse Medical Communication, System Analytic, Taylor and Francis, Tegus, Teva, Theranica, Trinity Partners, Unity HA, Vial, and XOC. He received salary from Dartmouth-Hitchcock Medical Center, Thomas Jefferson University, and Ki Health Partners. He serves on the Speakers Bureau for AbbVie, Eli Lilly, Pfizer, Scilex, and Teva. He received certified Continuing Medical Education CME honoraria from the American Academy of Neurology, American Headache Society, Annenberg Center for Health Sciences, Catamount Medical Education, Diamond Headache Clinic, Forefront Collaborative, Haymarket Medical Education, HMP Global, Medical Education Speakers Network, Medical Learning Institute Peerview, Migraine Association of Ireland, Miller Medical Education, National Association for Continuing Education, North American Center for CME, The Ohio State University, Physicians’ Education Resource, PlatformQ Education, Primed, Vindico Medical Education, and WebMD/Medscape. Sidsel Jensen, Line Pickering Boserup, Mette Krog Josiassen, and Bjørn Sperling are full-time employees of H. Lundbeck A/S. Sidsel Jensen, Mette Krog Josiassen, and Bjørn Sperling own stock in Lundbeck or one of its subsidiary companies.

: The study was conducted in accordance with standards of Good Clinical Practice as defined by the International Conference on Harmonisation and all applicable federal and local regulations. The local review board or a central institutional review board/ethics committee approved all study documentation at each of the 96 study sites across Europe and the US (Supplementary Materials Appendix ). All patients provided written informed consent prior to study participation. DELIVER is registered on ClinicalTrials.gov (NCT04418765) and EudraCT (2019–004497-25).