Sponsorship for this study and the journal’s Rapid Service Fee were funded by Allergan (prior to its acquisition by AbbVie).
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
Medical Writing, Editorial, and Other Assistance
Writing and editorial assistance was provided to the authors by Sean Sheffler-Collins, PhD, at Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, USA, and was funded by AbbVie. The opinions expressed in this article are those of the authors. The authors received no honorarium/fee or other form of financial support related to the development of this article.
Some of the data included in this manuscript were previously presented in poster form at the 13th European Headache Federation (EHF) Congress, May 30–June 1, 2019, Athens, Greece; the 5th Congress of the European Academy of Neurology (EAN), June 29–July 2, 2019, Oslo, Norway; the 61st Annual Scientific Meeting of the American Headache Society (AHS), July 11–14, 2019, Philadelphia, PA, USA; the Diamond Headache Clinic Research & Educational Foundation’s Headache (DHCREF) Update 2019, July 25–28, 2019, Lake Buena Vista, FL, USA; and the 19th Congress of the International Headache Society (IHC 2019), September 5–8, 2019, Dublin, Ireland.
Stephen D. Silberstein, MD: Consultant and/or advisory panel member for and has received honoraria from Alder Biopharmaceuticals, AbbVie, Amgen, Avanir, eNeura, ElectroCore Medical, Labrys Biologics, Medscape, Medtronic, Neuralieve, NINDS, Pfizer, and Teva. His employer receives research support from AbbVie, Amgen, Cumberland Pharmaceuticals, ElectroCore Medical, Labrys Biologics, Eli Lilly, Mars, and Troy Healthcare. Hans-Christoph Diener, MD, PhD: Received honoraria for participation in clinical trials, contribution to advisory boards, or oral presentations in the last 3 years from: Alder, AbbVie, Amgen, Bristol-Myers Squibb, Electrocore, Ipsen Pharma, Eli Lilly, Medtronic, MSD, Novartis, Pfizer, Teva, and Weber & Weber. Financial support for research projects was provided by AbbVie and Electrocore. HCD serves on the editorial boards of Cephalalgia and Lancet Neurology. HCD co-chairs the Clinical Guidelines Committee of the German Society of Neurology and is a member of the Clinical Trials Committee of the International Headache Society. David W. Dodick, MD: Reports the following conflicts within the past 12 months: Consulting: AEON, Amgen, Clexio, Cerecin, AbbVie, Alder, Biohaven, Linpharma, Lundbeck, Promius, Eli Lilly, eNeura, Novartis, Impel, Theranica, WL Gore, Nocira, XoC, Zosano, Upjohn (Division of Pfizer), Pieris, Revance, Equinox. Honoraria: CME Outfitters, Curry Rockefeller Group, DeepBench, Global Access Meetings, KLJ Associates, Majallin LLC, Medlogix Communications, Miller Medical Communications, Southern Headache Society (MAHEC), WebMD Health/Medscape, Wolters Kluwer, Oxford University Press, Cambridge University Press. Research Support: Department of Defense, National Institutes of Health, Henry Jackson Foundation, Sperling Foundation, American Migraine Foundation, Patient Centered Outcomes Research Institute (PCORI). Stock Options/Shareholder/Patents/Board of Directors: Aural Analytics (options), ExSano (options), Palion (options), Healint (options), Theranica (options), Second Opinion/Mobile Health (options), Epien (options/board), Nocira (options), Ontologics (options/board), King-Devick Technologies (options/board), Precon Health (options/board). Patent 17189376.1-1466:vTitle: Botulinum Toxin Dosage Regimen for Chronic Migraine Prophylaxis. Aubrey Manack Adams, PhD and Ronald E. DeGryse, MS, MA: Employees of AbbVie and may hold AbbVie stock. Richard B. Lipton, MD: Serves as consultant or advisory board member or has received honoraria from American Academy of Neurology, Alder, AbbVie, American Headache Society, Amgen, Biohaven, Biovision, Boston Scientific, Dr. Reddy’s, Electrocore, Eli Lilly, eNeura Therapeutics, GlaxoSmithKline, Merck, Pernix, Pfizer, Teva, Trigemina, Vector, and Vedanta. Holds stock options in eNeura and Biohaven.
Compliance with Ethics Guidelines
Both trials discussed in this article were conducted in accordance with the Declaration of Helsinki Code of Federal Regulations and Good Clinical Practices and US requirements of public registration (NCT00156910 [PREEMPT 1] and NCT00168428 [PREEMPT 2]). Investigators at each investigational site obtained approval from an independent ethics committee or a local institutional review board prior to study initiation. Written informed consent was obtained from each randomized patient.
Data reported in this manuscript are available within the article and/or its supplementary materials. AbbVie will share de-identified patient-level data and/or study-level data, including protocols and clinical study reports, for phase 2–4 trials completed after 2008 that are registered on ClinicalTrials.gov or EudraCT. The indication studied in the trial must have regulatory approval in the United States and/or the European Union and the primary manuscript from the trial must be published prior to data sharing. To request access to the data, the researcher must sign a data use agreement. All shared data are to be used for non-commercial purposes only. More information can be found on https://www.allerganclinicaltrials.com/PatientDataRequest.htm.