Kudrow, David
Cady, Roger K.
Allan, Brent
Pederson, Susan M.
Hirman, Joe
Mehta, Lahar R.
Schaeffler, Barbara A.
Article History
Received: 31 December 2020
Accepted: 18 February 2021
First Online: 19 March 2021
Declarations
:
: The independent ethics committee and/or institutional review board for each site approved the study; there were a total of 20 sites: Medical Center for Clinical Research (WR-MCCR), LLC (San Diego, CA), Neurological Research Institute (Santa Monica, CA), Delta Waves, Inc. (Colorado Springs, CO), Meridien Research (Bradenton, FL), Avail Clinical Research, LLC (DeLand, FL), Allied Biomedical Research Institute (Miami, FL), Meridien Research (Tampa, FL), Clinical Research of Central Florida (Winter Haven, FL), Phoenix Medical Research, Inc. (Prairie Village, KS), Boston Clinical Trials (Boston, MA), Tristan Medical Enterprises, PC dba Regeneris Medical (North Attleboro, MA), MedVadis Research Corporation (Watertown, MA), Clinical Research Institute, Inc. (Minneapolis, MN), Integrative Clinical Trials LLC (Brooklyn, NY), Rochester Clinical Research, Inc. (Rochester, NY), Urgent Care Specialists LLC (Dayton, OH), Coastal Carolina Research Center (Mount Pleasant, SC), WR-ClinSearch, LLC (Chattanooga, TN), Ventavia Research Group, LLC (Fort Worth, TX), and Northwest Clinical Research Center (Bellevue, WA). All clinical work was conducted in compliance with current Good Clinical Practices as referenced in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline E6, local regulatory requirements, and the principles of the Declaration of Helsinki. All patients provided written informed consent prior to participation.
: Not applicable.
: ● D. Kudrow: <i>Advisory board and/or speaker:</i> Amgen, Biohaven, Eli Lilly, Lundbeck Seattle BioPharmaceuticals, Novartis, Promius Pharma; <i>Research support:</i> Allergan, Amgen, Biohaven, Eli Lilly, Genentech, Lundbeck Seattle BioPharmaceuticals, Novartis, Roche Pharma, Teva, UCB, ViroMed; <i>Speaker’s Bureau:</i> Amgen/Novartis, Eli Lilly.● R. Cady, S. Pederson, L. Mehta: <i>Full-time employee</i>: Lundbeck Seattle BioPharmaceuticals.● B. Allan: <i>Full-time employee at the time of study</i>: Alder Biopharmaceuticals (CKA Lundbeck Seattle Biopharmaceuticals).● J. Hirman: <i>Contracted service provider of biostatistical resources</i>: Lundbeck Seattle BioPharmaceuticals.● B. Schaeffler: <i>Full-time employee at the time of the study and during manuscript development</i>: Lundbeck Seattle BioPharmaceuticals.