Document is current

Article History

Accepted: 25 June 2023

First Online: 18 July 2023

Declarations

:

: This work was funded by Pfizer and Eli Lilly and Company. Pfizer and Eli Lilly and Company contributed to the study design; Pfizer contributed to the management and collection of data. In their role as authors, employees of Pfizer and Eli Lilly were involved in the interpretation of data, preparation, review, and approval of the manuscript and the decision to submit for publication, along with their co-authors. The study sponsors approved the manuscript from an intellectual property perspective but had no right to veto the publication.

: DRC has served as a consultant for AlgoTX, Amgen Inc., Annexon Biosciences, Boehringer Ingelheim, Cigna Health Management Inc., CSL Behring, Grifols S.A., Johnson & Johnson, Nervosave, Nurobio, Octapharma AG, Passage Bio, Pfizer Inc., Pharnext SAS, Roche, Seattle Genetics Inc., and ValenzaBio. He sits on the Data Safety Monitoring Board for Anavex Life Sciences Corp, Passage Bio, PledPharma AB, Hansa Medical AB, and Mitsubishi Tanabe Pharma Corporation. Through Johns Hopkins University, he receives royalties for technology licensing from AstraZeneca Pharmaceuticals, LP, Genentech Inc., Levicept Inc., Seattle Genetics Inc., and Merrimack Pharmaceuticals. He sits on the Scientific Advisory Board for AlgoTx and Sinomab. MK is director of Neurophysiology Consulting Ltd and QTMS Science Ltd. During the past 5 years he has been an ad hoc consultant and the speaker bureau for Eli Lilly, GSK, Levicept, Marks & Clerk Law, Merck, Neursentis, Pfizer, Richmond Pharmaceuticals Ltd., and Roche. KG has served as a consultant for Argenx, Annexon, Janssen, Pfizer, and UCB Pharma. MTB, AH, GCP, PG, and CRW own stock in and are full-time employees of Pfizer. LV owns stocks in and is a full-time employee of Eli Lilly and Company.

: Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions, and exceptions, Pfizer may also provide access to the related individual de-identified participant data. Seefor more information.

: The protocol for each clinical trial was approved by an institutional review board or independent ethics committee at each participating investigational center. The studies were conducted in compliance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice Guidelines.

: Not applicable.

: All patients provided written informed consent before entering the studies.

: Mark Brown: Conceptualization, data curation, investigation, methodology, supervision, visualization, and writing (review and editing). David Cornblath: Investigation, supervision, and writing (review and editing). Martin Koltzenburg: Investigation, supervision, and writing (review and editing). Kenneth Gorson: Investigation, supervision, and writing (review and editing). Anne Hickman: Conceptualization, data curation, investigation, methodology, supervision, visualization, and writing (review and editing). Glenn C. Pixton: Conceptualization, data curation, formal analysis, investigation, methodology, supervision, visualization, and writing (review and editing). Puneet Gaitonde: Data curation, investigation, methodology, supervision, visualization, and writing (review and editing). Lars Viktrup: Conceptualization, methodology, supervision, visualization, and writing (review and editing). Christine West: Conceptualization, data curation, investigation, methodology, supervision, visualization, and writing (review and editing).

: Not applicable.