Ailani, Jessica
McAllister, Peter
Winner, Paul K.
Chakhava, George
Krog Josiassen, Mette
Lindsten, Annika
Sperling, Bjørn
Ettrup, Anders
Cady, Roger
Funding for this research was provided by:
H. Lundbeck A/S
Article History
Received: 1 February 2022
Accepted: 11 May 2022
First Online: 3 June 2022
Change Date: 6 September 2023
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1186/s12883-023-03368-3
Declarations
:
: The independent ethics committee and/or institutional review board for each site approved the study; there were a total of 57 sites: Alabama Clinical Therapeutics (Birmingham, AL, United States), Arizona Research Center (Phoenix, AZ, United States), Baptist Health Center for Clinical Research (Little Rock, AR, United States), Advanced Research Center (Anaheim, CA, United States), The Neurology Center of Southern California – Carlsbad (Carlsbad, CA, United States), Excell Research Inc. (Oceanside, CA, United States), Anderson Clinical Research (Redlands, CA, United States), University of Colorado Hospital (Aurora, CO, United States), Denver Neurological Clinic – Denver (Denver, CO, United States), Coastal Connecticut Research LLC (New London, CT, United States), Ki Health Partners LLC, dba New England Institute for Clinical Research (Stamford, CT, United States), The George Washington Medical Faculty Associates (Washington, District of Columbia, United States), Medicinae Doctor Clinical (Hallandale Beach, FL, United States), AGA Clinical trials (Hialeah, FL, United States), Meridien Research – Maitland (Maitland, FL, United States), Palm Beach Neurology and Premiere Research Institute, (West Palm Beach, FL, United States), Clinical Research of Central Florida (Winter Haven, FL, United States), Office of Doctor Frank Berenson (Atlanta, GA, United States), iResearch Atlanta, LLC (Decatur, GA, United States), Meridian Clinical Research—Savannah Neurology Specialists (Savannah, GA, United States), Cedar Crosse Research Center (Chicago, IL, United States), College Park Family Care Center Physicians (Overland Park, KS, United States), Phoenix Medical Research (Prairie Village, KS, United States), Central Kentucky Research Associates (Lexington, KY, United States), Boston Clinical Trials (Boston, MA, United States), MedVadis Research Corporation, LLC (Waltham, MA, United States), Michigan Head Pain and Neurological Institute (Ann Arbor, MI, United States), Clinical Research Institute – Minneapolis (Minneapolis, MN, United States), Headache Neurology Research Institute (Ridgeland, MS, United States), StudyMetrix Research (Saint Peters, MO, United States), Clinvest Research (Springfield, MO, United States), Nevada Headache Institute (Las Vegas, NV, United States), Albuqerque Clinical Trials (Albuquerque, NM, United States), Dent Neurologic Institute – Amherst (Amherst, NY, United States), Integrative Clinical Trials (Brooklyn, NY, United States), CTI Clinical Research Center (Cincinnati, OH, United States), Aventiv Research – Columbus (Columbus, OH, United States), Hometown Urgent Care and Research—Huber Heights (Dayton, OH, United States), Neuro-Behavioral Clinical Research Inc. (North Canton, OH, United States), Delricht Research (Tulsa, OK, United States), Summit Research Network (Portland, OR, United States), Frontier Clinical Research LLC (Smithfield, PA, United States), Coastal Carolina Research Center–Mount Pleasant (Mount Pleasant, SC, United States), Chattanooga Medical Research LLC (Chattanooga, TN, United States), WR-ClinSearch LLC (Chattanooga, TN, United States), Holston Medical Group – Kingsport (Kingsport, TN, United States), Ventavia Research Group, LLC (Fort Worth, TX, United States), Texas Center for Drug Development Inc. (Houston, TX, United States), Ventavia Research Group, LLC (Keller, TX, United States), J. Lewis Research, Inc. /Foothill Family Clinic (Salt Lake City, UT, United States), Northwest Clinical Research Center (Bellevue, WA, United States), Neuroscience Group (Neenah, WI, United States), Acad Fridon Todua Medical Center–Ltd Research Institute of Clinical Medicine (Tbilisi, Georgia), Aversi Clinic (Tbilisi, Georgia), Multiprofile Clinica Consilium Medulla (Tbilisi, Georgia), Simon Khechinashvili University Clinic (Tbilisi, Georgia), and Israel-Georgia Medical Research Clinic Helsicore (Tbilisi, Georgia). The RELIEF study was conducted in accordance with standards of Good Clinical Practice as defined by the International Conference on Harmonisation and all applicable federal and local regulations. All study documentation was approved by the local review board at each site or by a central institutional review board or ethics committee. All patients provided written informed consent prior to their participation in the study.
: Not applicable.
: JA has received research support from AbbVie, Biohaven, Lilly, Satsuma, and Zosano; consulting fees from AbbVie, Aeon, Amgen, Axsome, Biodelivery Sciences International, Biohaven, GlaxoSmithKline, Impel, Lilly, Lundbeck, Nesos, Satsuma, Teva, and Theranica; and speaker fees from AbbVie, Amgen, Biohaven, Lilly, Lundbeck, and Teva.PM has received personal fees and research support from AbbVie, Amgen/Novartis, Biohaven, Lilly, Lundbeck, and Teva.PKW has received consulting fees from AbbVie, Amgen, Biohaven, Lilly, Lundbeck, Novartis, and Teva; served on Speaker bureaus for AbbVie, Amgen, Biohaven, Lilly, Lundbeck, Novartis, and Teva; and received research support from AbbVie, Amgen, AZ, Biogen, Lilly, Lundbeck, Novartis, Supernus, and Teva.GC has nothing to declare.MKJ, AL, BS, and AE are full-time employees of H. Lundbeck A/S.RC was an employee of Lundbeck or one of its subsidiary companies at the time of study and manuscript development.