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Article History

Received: 19 December 2024

Accepted: 20 August 2025

First Online: 13 September 2025

Declarations

:

: No funding was provided for this study.

: Melanie Jacobson and Gayle Murray are employees of and hold stock in Johnson & Johnson. Sandra Lopez-Leon and Vineetkumar Kharat are employees of and hold stock in Novartis Pharma. Meritxell Sabidó is an employee of Merck Healthcare KGaA. Dimitri Bennett is an employee of Takeda. Marie-Laure Kürzinger is an employee of Sanofi. Susan Andrade has received research support from Pfizer, Inc. and GlaxoSmithKline. Ditte Mølgaard-Nielsen is an employee of Novo Nordisk. Elena Rivero-Ferrer is an employee of RTI Health Solutions, a unit of RTI International, an independent, nonprofit organization that conducts work for government, public, and private organizations, including pharmaceutical companies. Adebola Ajao is an employee of the US FDA. Eman Alghamdi is an employee of the Saudi FDA. Maryline Le Noan-Lainé and Ana Sofia Afonso are employees of and hold stock in Eli Lilly. The views expressed in this paper are those of the author(s) and not do not necessarily reflect those of the US FDA, the Saudi FDA, or their stakeholders. Guaranteeing the accuracy and the validity of the data is a sole responsibility of the research team.

: The dataset used and/or analyzed in the current study is available within this article and/or figures, tables, and appendices.

: Not applicable.

: MHJ and SLL designed the study. MHJ contributed critical direction and overall project administration. MHJ, SLL, and GM undertook the literature search. All authors participated in data extraction and in the drafting and critical revisions of this article for critical intellectual content. All authors read and approved the final version of this article.

: No ethical approval was needed as this research did not involve human subjects, nor were any human subject data captured, extracted, or analyzed.

: Not applicable.

: Not applicable.

: Abstract accepted and presented as a poster at the International Society for Pharmacoepidemiology Annual Meeting, August 2024, Berlin, Germany.