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Article History

Received: 17 February 2025

Accepted: 8 April 2025

First Online: 24 April 2025

Declarations

:

: This study was funded by Pfizer Inc. Ernest H. Law, Helen Tran, and Lynne Napatalung report employment with and stock ownership in Pfizer Inc. Kent A. Hanson served as a paid consultant to Pfizer during the period in which the work for this manuscript was conducted; the author is no longer affiliated with the company. Keith L. Davis and Lizzi Esterberg report employment with RTI Health Solutions, which received contract research funding from Pfizer Inc. for the conduct of this study. Andrew Messenger and Sergio Vañó-Galván report consultancy fees from Pfizer Inc. in relation to the conduct of this study.

: The study was subjected to ethics review and approval (or exemption, as applicable) based on local, country-specific requirements. In the UK, based on the National Health Service’s Health Research Authority (HRA) online decision tool, the study was classified as a service evaluation or clinical/non-financial audit; thus, the study was exempt from research ethics committee review (HRA decision tool certificate of exemption available upon request). In France, based on the retrospective, non-interventional study design in which only fully anonymized data were collected and retained, the study required only attestation of compliance with MR-004 (research methodology 004) to the Commission Nationale Informatique and Libertés. In Germany, the study underwent independent ethics committee (IEC) review (with subsequent approval) with the Ethikkommission der Bayerischen Landesärztekammer, in addition to notification of study conduct to the Ethikkommission der Bayerischen Landesärztekammer. In Spain, IEC review (and subsequent approval) was obtained from Hospital Universitario La Paz, with competent authority notification to Agencia Española de Medicamentos y Productos Sanitarios.