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Article History

Received: 13 November 2025

Accepted: 21 January 2026

First Online: 11 February 2026

Declarations

:

: Patricia Pozo-Rosich, in the past 36 months, has received honoraria as a consultant and speaker from AbbVie, Almirall, Dr. Reddy’s, Eli Lilly, Lundbeck, Medscape, Novartis, Organon, Otsuka Pharmaceuticals, Pfizer, and Teva. Her research group has received research grants from AbbVie, AGAUR, EraNet Neuron, FEDER RIS3CAT, Instituto Investigación Carlos III, MICINN, Novartis, and Teva and funding for clinical trials from AbbVie, Amgen, Biohaven, Eli Lilly, Lundbeck, Novartis, Pfizer, and Teva. She is the Honorary Secretary of the International Headache Society, a member of the Clinical Trials Guidelines Committee of the International Headache Society, an associate editor for Cephalalgia and Neurologia , and the founder of , a platform to give information and tools to physicians and people who suffer from migraine and other headaches. Cristina Tassorelli, in the past 36 months, has been Principal Investigator in clinical trials sponsored by AbbVie, Biohaven, Eli Lilly, Ipsen, Lundbeck, Pfizer, and Teva and has received: support (financial or drugs) from AbbVie and Novartis for an investigator-initiated trial; consulting fees for the participation in advisory boards from AbbVie, Dompé, Eli Lilly, Ipsen, Lundbeck, Medscape, Pfizer, and Teva; honoraria for scientific lectures and presentations from AbbVie, Eli Lilly, Lundbeck, Pfizer, and Teva; support for attending meetings from AbbVie, Dompé, Eli Lilly, Ipsen, Lundbeck, Pfizer, and Teva; and grants from the European Commission, the Italian Ministry of Health, and the Italian Ministry of University. Line Pickering Boserup and Susanne F. Awad are full-time employees of H. Lundbeck A/S. Xin Ying Lee was a full-time employee of H. Lundbeck A/S during data analysis and initial manuscript stages. She is currently an employee of Novo Nordisk, which was not involved in nor has competing interest with this study. Jessica Ailani, in the past 36 months, has served as a consultant for AbbVie, Aeon, Dr. Reddy’s, Eli Lilly, eNeura, GlaxoSmithKline, Gore, Ipsen, Linpharma, Lundbeck, Merz, Neurolief, Pfizer, Satsuma, Scilex, Theranica, Tonix, and Vectura Fertin; has received clinical trial support from AbbVie, Ipsen, Lundbeck, Mi-Helper, and Parema; and has provided editorial services to SELF magazine.

: The trial was conducted in compliance with current Good Clinical Practices as defined in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines, local regulatory requirements, and the Declaration of Helsinki policy statement. 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 (Table ). All participants provided written informed consent prior to trial participation. DELIVER is registered on ClinicalTrials. gov (NCT04418765) and EudraCT (2019–004497–25).