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Article History

Received: 1 October 2021

Accepted: 6 January 2022

First Online: 21 February 2022

Declarations

:

: Approval for PROMISE-2 was provided by the independent ethics committee or institutional review board of the study sites. PROMISE-2 was conducted in accordance with Good Clinical Practice guidelines, the principles of the Declaration of Helsinki, and all applicable regulatory requirements. Patients provided written informed consent prior to initiation of any study procedures.

: Not applicable.

: DCB: Received grant support from Amgen, the National Headache Foundation and the FDA; received consulting support from Allergan/Abbvie, Amgen, Lilly, Lundbeck, and Teva; and serves on the editorial board of <i>Current Pain and Headache Reports</i>.PKW: Receives consulting fees from Abbvie, Aeon, Amgen, Axsome, Biohaven, GlaxoSmithKline, Impel, Lilly, Lundbeck, Nesos, Satsuma, Theranica, and Teva; serves on speaker bureaus for Abbvie, Amgen, Biohaven, Lilly, Lundbeck, Novartis, Teva; and receives research support from AbbVie, Biohaven, Lilly, Satsuma, and Zosano.LCIV: Receives personal compensation for serving as a consultant for Alder/Lundbeck, Allergan/AbbVie, Biohaven, Satsuma, and Teva and for serving as an Expert Witness for Vaccine Injury Compensation Program. He is on the advisory panel of Ctrl M Health (stock). In addition, he is a non-compensated Associate Editor with <i>Headache</i> and has a non-compensated relationship as a Board Member at Large with Alliance for Headache Disorders Advocacy.JH: Employee of Pacific Northwest Statistical Consulting, Inc., a contracted service provider of biostatistical resources for H. Lundbeck A/S.RC: Employee of Lundbeck or one of its subsidiary companies at the time of study and manuscript development.TB: Employee of H. Lundbeck A/S or one of its subsidiary companies and has equity in H. Lundbeck A/S.