Document is current

Article History

Received: 15 December 2025

Accepted: 16 April 2026

First Online: 17 July 2026

Declarations

Conflict of Interest: Dawn C. Buse has received research support from the United States Food and Drug Administration (FDA) and the National Headache Foundation. She serves as consultant or advisory board member or has received honoraria or research support from AbbVie/Allergan, Amgen, Biohaven, Eli Lilly and Company, Ipsen, Lundbeck, Novartis, Teva, and Theranica. E. Jolanda Muenzel is an employee and minor stockholder of Eli Lilly and Company. Ali Sheikhi Mehrabadi was an employee and minor stockholder of Eli Lilly and Company at the time of study. He is now an employee of the School of Medicine, University of Limerick, Limerick, Ireland. Anthony J. Zagar was an employee of Eli Lilly and Company and remains a minor stockholder. Armen Zakharyan is employed by TechData, a company contracted by Eli Lilly and Company (sponsor) to perform the statistical analysis. Sait Ashina has received support for consulting, teaching, and honoraria from Allergan/AbbVie, Amgen, Axsome Therapeutics, Biohaven, Eli Lilly and Company, Impel NeuroPharma, Linpharma, Lundbeck, Novartis, Satsuma, Supernus, Percept, Pfizer, Teva, and Theranica. Robert E. Shapiro serves as consultant or advisory board member or has received honoraria or research support from Eli Lilly and Company, AbbVie, Theranica, Amneal Pharmaceuticals, and Lundbeck. Gilwan Kim is an employee and minor stockholder of Eli Lilly and Company. Robert A. Nicholson is an employee and minor stockholder of Eli Lilly and Company. Richard B. Lipton has received research support from the National Institutes of Health, the FDA, and the National Headache Foundation. He serves as consultant or advisory board member or has received honoraria or research support from AbbVie/Allergan, Amgen, Biohaven, Dr. Reddy's Laboratories (Promius), electroCore, Eli Lilly and Company, GlaxoSmithKline, Eli Lilly and Company, Lundbeck, Merck, Novartis, Pfizer, Teva, Vector, and Vedanta Research. He receives royalties from Wolff's Headache, 8th edition (Oxford University Press, 2009), and Informa. He holds stock/options in Axon, Biohaven, Cooltech, and Manistee.

Ethical Approval: The study was approved by the Sterling Institutional Review Board (IRB ID #6425–001). All participants provided informed consent to participate in the study. The study was conducted in accordance with the Helsinki Declaration of 1964 and its later amendments, consistent with Good Pharmacoepidemiology Practices and applicable laws.

Disclosures: Anthony J Zagar is now retired and Ali Sheikhi Mehrabadi is now an employee of the School of Medicine, University of Limerick, Limerick, Ireland.