Document is current

Article History

Received: 7 October 2024

Accepted: 18 December 2024

First Online: 1 February 2025

Declarations

:

: Peter J. Goadsby reports, over the last 36 months, personal fees from Sanofi; grant from Kallyope, and personal fees from Aeon Biopharma, AbbVie, Aurene, CoolTech LLC, Dr Reddy’s, Eli Lilly and Company, Linpharma, Lundbeck, Pfizer, PureTech Health LLC, Satsuma, ShiraTronics, Teva Pharmaceuticals, Tremeau, and Vial; personal fees for advice from Gerson Lehrman Group, Guidepoint, SAI Med Partners, and Vector Metric; fees for educational materials from CME Outfitters; and publishing royalties or fees from Massachusetts Medical Society, Oxford University Press, UptoDate, and Wolters Kluwer. Peter J. Goadsby is an Editorial Board member of Pain and Therapy. He was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Andrew Stewart has received honoraria for advisory boards and educational talks from Allergan/AbbVie, AllergoSan, Eli Lilly, Lundbeck, Novartis, Sanofi, and Teva. Mamoru Shibata has no competing interests. Mario Fernando Prieto Peres has received personal fees from Ache, Allergan/AbbVie, Eli Lilly, Eurofarma, Libbs, Lundbeck, Novartis, Pfizer, Sanofi, and Teva, and has received research support from Allergan/AbbVie, Eli Lilly, Eurofarma, Janssen-Cilag, Libbs, Natura, Novartis, and Teva. Mary Kay Margolis is a former employee of PPD, part of Thermo Fisher Scientific, which provides consulting and other research services to pharmaceutical, device, government, and non-government organizations. As a PPD employee, she worked with a variety of companies and organizations and was expressly prohibited from receiving any payment or honoraria directly from these organizations for services rendered. Chris Colby is an employee of PPD, part of Thermo Fisher Scientific. Valentine Polivka is an employee of the AIXIAL Group, an ALTEN company, which provides statistical consulting and research services to Sanofi, and has no other competing interests. Luminita Constantin, Caroline Amand, and Andrew Stewart are currently employees of Sanofi and may hold shares and/or stock options in the company.

: The study (21062-01) was submitted and approved by the US Institutional Review Board (IRB): Ethical and Independent (E&I) Review Services, which is now known as Salus IRB. The study was approved by local ethics committees in Germany, Brazil, and Japan. All participants provided informed consent electronically before initiation of data collection.