The authors thank all the study participants, site investigators, and personnel involved in the CONQUER study. The authors thank Robert A Nicholson for medical review of this manuscript (employee of Eli Lilly and Company).
Sponsorship for this study and all associated publication costs, including the journal’s Rapid Service and Open Access Fees were funded by Eli Lilly and Company.
Medical Writing and Editorial Assistance
We thank Angela O’Sullivan and Sinead Ryan (both employees of Eli Lilly and Company) for their contribution to the writing and editing of this manuscript.
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.
Study concept and design: Jeffrey Scott Andrews, Mallikarjuna Rettiganti; Analysis and interpretation of data: Mallikarjuna Rettiganti, Jeffrey Scott Andrews; Drafting of the manuscript: Mallikarjuna Rettiganti; Manuscript revision for intellectual content: Jessica Ailani, Jeffrey Scott Andrews, Richard Wenzel, Antje Tockhorn-Heidenreich, Mallikarjuna Rettiganti; Final approval of the completed manuscript: Jessica Ailani, Jeffrey Scott Andrews, Antje Tockhorn-Heidenreich, Richard Wenzel, Mallikarjuna Rettiganti.
The results have previously been presented at the following congresses: the European Academy of Neurology—7th Congress 2021, June 19–22, 2021, virtual; American Neurological Association—146th Annual Meeting, October 17–19, 2021, virtual; and PAIN Week 2021, September 7–11, 2021, Las Vegas, USA.
Antje Tockhorn-Heidenreich, Richard Wenzel, and Mallikarjuna Rettiganti are employees and stockholders of Eli Lilly and Company. Jessica Ailani reports honoraria for independent consulting from Amgen, Abbvie, Biohaven, BioDelivery Scientific International, Eli Lilly and Company, Lundbeck, Teva, Impel, Satsuma, Theranica, Axsome, Neso, GlaxoSmithKline, Aeon, Medscape, Neurolief; ownership of Stocks CtrlM; Speakers Bureau/honoraria for promotional speaking from Allergan/Abbvie, Amgen, Biohaven, Eli Lilly and Company, Lundbeck, Teva; Editorial services/Honoraria from Current Pain and Headache Reports, Section editor, Unusual Headache Syndromes, NeurologyLive, SELF (medical reviewer); and clinical Trial Grants (Fees to Institution) from American Migraine Foundation, Allergan, Biohaven, Eli Lilly and Company, Satsuma, and Zosano. Jeffrey Scott Andrews is an employee and stockholder of Takeda Pharmaceuticals, Limited, and was an employee of Eli Lilly and Company during the conduct of this study.
Compliance with Ethics Guidelines
Appropriate institutional review boards reviewed and approved the study, which was conducted according to the Declaration of Helsinki, and all subjects provided informed consent to participate in the study.
Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the USA and EU and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at www.vivli.org.