Camporeale, Angelo
Kudrow, David
Sides, Ryan
Wang, Shufang
Van Dycke, Annelies
Selzler, Katherine J.
Stauffer, Virginia L.
Funding for this research was provided by:
Eli Lilly and Company
Article History
Received: 28 February 2018
Accepted: 31 October 2018
First Online: 9 November 2018
Ethics approval and consent to participate
: This study was reviewed and approved by appropriate institutional review boards and was conducted according to Good Clinical Practice and the Declaration of Helsinki. The ethical review boards included: Commissie Medische Ethiek Universitair Ziekenhuis (Institutes: Clinique St. Joseph, Algemeen Ziekenhuis St Jan Brugge, Universitair Ziekenhuis Brussel; Belgium), IRB Services (Institutes: DIEX Recherche Sherbrooke, Inc., Stroyan Research; Canada), Conjoint Medical Ethics Committee (Institute: University of Calgary, Canada), CPP Sud Mediterannée V (Institutes: CHU St Etienne Hôpital Nord, Hôpital de la Timone, Hôpital de Cimiez, Hôpital Lariboisiere; France), Egeszsegugyi Tudomanyos Tanacs (Institutes: Orszagos Idegtudomanyi Intezet, Petz Aladar Megyei Oktato Korhaz, SE Neurologiai Klinika, Valeomed Kft.; Hungary), Quorum Review, Inc. (Institutes: Wilmington Health Associates, Mercy Health Research, Blue Ridge Research Center, Jacksonville Center for Clinical Research, Ericksen Research and Development, Suburban Research Associates, California Medical Clinic for Headache, Albuquerque Neuroscience, Inc., ClinPoint Trials, LLC, Encompass Clinical Research, New England Institute for Clinical Research, Infinity Clinical Research, LLC, PharmQuest, Ponce School of Medicine CAIMED Center; USA).Patients provided written informed consent before initiating study procedures. The ethics committee approval covers all the sites in each country at the national level.
: Not applicable.
: AC, SW, KJS, and VLS are full-time employees and minor shareholders of Eli Lilly and Company or one of its affiliates. RS was a full-time employee of Eli Lilly and Company at the time the manuscript was submitted. DK has received consultant fees from Eli Lilly, Amgen, Novartis and Alder and has received research support from Eli Lilly, Amgen, Alder, Teva, Allergan, Biohaven, CoLucid, VM Biopharma, and Roche-Genentech. AVD has received speaker fees from UCB, GSK, and Pfizer.
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