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Article History

Received: 12 September 2024

Accepted: 8 May 2025

First Online: 27 May 2025

Change Date: 24 July 2025

Change Type: Update

Change Details: Affiliations have been updated to correctly correspond to the author group.

Declarations

:

: Each data source–specific study was conducted in accordance with the relevant Good Epidemiological Practice guidelines (the International Society for Pharmacoepidemiology Guidelines for Good Pharmacoepidemiology Practices and/or the German guidelines and recommendations for ensuring Good Epidemiological Practice [, ]) and the ethical principles that have their origin in the Declaration of Helsinki. Respective applicable laws and regulatory requirements in Canada, England, and Germany were followed. The O2 protocol received approval by the Health Research Ethics Board of Alberta. The CAS and VONKOdb protocols did not require ethical approval; however, the VONKOdb data extraction and analyses were approved by the Ethics Committee of the University of Lübeck (#20–483). Individual patient data were analyzed by authorized staff at each data source, with only aggregated data released to the wider study teams. Given the country-specific rules described above, and since these were non-interventional, retrospective observational studies using pseudo-anonymized patient data, informed consent was not required.

: Not applicable.

: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: AG reports funding and medical writing support from Bristol Myers Squibb (BMS); consulting fees from AstraZeneca, BMS, MSD, and Roche; honoraria from AstraZeneca; support for attending meetings from Roche; and research funding (institution) from AstraZeneca. MJD reports employment by BMS at the time of these analyses, and stock or stock options in BMS. CR reports no conflicts of interest. HB reports funding and medical writing support from BMS. PQD reports no conflicts of interest. GE, SL, and LV report employment by BMS; SL and LV also report stock or stock options in BMS. VMS, ER, CL, and MJS report employment by IQVIA, a contract research organization contracted by the study sponsor, BMS. AK reports funding and medical writing support from BMS; and support for attending meetings from BMS. AW reports funding and medical writing support from BMS; and support for attending meetings from BMS. WYC reports no conflicts of interest.