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Article History

Received: 3 May 2024

Accepted: 18 October 2024

First Online: 13 February 2025

Declarations

:

: The Clinical Practice Research Datalink’s (CPRD) supplies anonymised UK health data for public health research sponsored by the National Institute for Health Research (NIHR) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). The UK’s Health Research Authority Research Ethics Committee (East Midlands - Derby Research Ethics Committee) provides ethical approval to CPRD annually. No additional ethical approval is required for observational studies using CPRD Aurum data for public health research, subject to individual research protocols meeting CPRD data governance requirements. Therefore, informed consent is deemed unnecessary by CPRD. However, access to the CPRD database does require approval from CPRD’s Research Data Governance (RDG) committee; this study was approved by CPRD’s RDG: CPRD study ID: 22_002431, and therefore is covered by CPRD’s ethical approval.

: Not applicable.

: This study was sponsored by Pfizer. JY, TA, LM, KMA, CT, RB, CR DM and JLN are employees of Pfizer and may hold stock or stock options. KKR, TT, LM and OM are employees of Adelphi Real World, which received funds from Pfizer to conduct the study and develop the manuscript.

: Funding for this study was provided by Pfizer Inc. The study protocol was developed collaboratively by Pfizer and Adelphi Real World. The protocol was independently reviewed and approved by CPRD’s Research Data Governance (RDG) committee, and the analysis was conducted by Adelphi Real World. Adelphi Real World wrote the first draft of the manuscript, and both Pfizer and Adelphi Real World reviewed and approved the manuscript prior to submission.