Accepted for Publication: September 12, 2022.
Published: October 28, 2022. doi:10.1001/jamanetworkopen.2022.39053
Open Access: This is an open access article distributed under the terms of the CC-BY-NC-ND License. © 2022 Rofail D et al. JAMA Network Open.
Corresponding Author: Diana Rofail, PhD, Regeneron Pharmaceuticals, Inc, One Rockwood Rd, Sleepy Hollow, NY 10591 (diana.rofail@regeneron.com).
Author Contributions: Drs Rofail and Griffiths had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Rofail, Griffiths, Hussein, Sivapalasingam, Rodriguez, Mastey, Gwaltney.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Rofail, Griffiths, Podolanczuk, Gwaltney.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Griffiths, Flore, Rodriguez, Gwaltney.
Obtained funding: Rofail.
Administrative, technical, or material support: Rofail, Hussein, Sivapalasingam.
Supervision: Rofail, Hussein, Podolanczuk, Rodriguez, Mastey.
Conflict of Interest Disclosures: Dr Rofail reported being a Regeneron Pharmaceuticals, Inc employee, and a former Roche employee and current stockholder. Dr Griffiths reported being an employee of IQVIA, which received consulting fees from Regeneron Pharmaceuticals, Inc for data collection, data analysis, and to support data interpretation during the conduct of the study. Mr Flore reported being an employee of IQVIA, which received consulting fees from Regeneron Pharmaceuticals, Inc for data collection, data analysis, and to support data interpretation during the conduct of the study. Dr Hussein reported being a Regeneron Pharmaceuticals, Inc. employee. Dr Podolanczuk reported receiving personal fees from Regeneron Pharmaceuticals, Inc during the conduct of the study, personal fees from Imvaria, Boehringer Ingelheim, EBSCO/Dynamed, and Roche outside the submitted work. Ms Mastey reported being a Regeneron Pharmaceuticals, Inc employee. Dr Gwaltney reported receiving personal fees from IQVIA during the conduct of study and outside the submitted work.No other disclosures were reported.
Funding/Support: This research was funded by Regeneron Pharmaceuticals, Inc.
Role of the Funder/Sponsor: Regeneron Pharmaceuticals, Inc designed, conducted, and supported the trial that collected the electronic symptom diary data and other data analyzed for this study. The finalized database was electronically transferred to IQVIA. Regeneron Pharmaceuticals, Inc was involved in the design of this study and in partnership with IQVIA the determination of the statistical psychometric analysis plan by consensus; supported the analysis of the data, performed by IQVIA; and was involved in the interpretation of results. Regeneron Pharmaceuticals, Inc and all authors were involved in the review and approval of the manuscript, and the decision to submit the manuscript for publication.
Additional Contributions: We thank the study participants, their families, and the clinicians involved in this trial. Medical writing assistance was provided by Hervé Besson, PhD, and Montse Casamayor, MD, PhD, from IQVIA; these writers did not receive any compensation beyond their normal salary. Editorial support was provided by Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc.
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