Document is current

Article History

Received: 16 July 2025

Accepted: 1 September 2025

First Online: 21 October 2025

Declarations

:

: Erwin De Cock was an employee of Syneos Health at the time of the study. Since the time of the study, Erwin De Cock is no longer affiliated with Syneos Health. Cecilia Lourdudoss is an employee of Syneos Health. Sabine Oskar, Renata Eiras, M. Catherine Pietanza, and Ashwani Arunachalam are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (MSD), who may own stock and/or hold stock options in Merck & Co., Inc., Rahway, NJ, USA. Gustavo Alves received research support from MSD, grants or contracts from Roche, AstraZeneca, Bristol Myers Squibb, MSD, Merck Serono, Pfizer, BeiGene, Ipsen; consulting fees from AstraZeneca and MSD; payment or honoraria from GlaxoSmithKline, AstraZeneca, MSD; and travel support from Janssen Pharmaceuticals. Gaston Lucas Martinengo reported no conflicts of interest. Enriqueta Felip reported receiving consulting fees from AbbVie, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daichii, F. Hoffmann–La Roche, Gilead, GlaxoSmithKline, Iteos Therapeutics, Janssen Pharmaceuticals, Johnson & Johnson, MSD, Novartis, Pierre Fabre, Pfizer, Regeneron, Turning Point; payment or honoraria from Amgen, AstraZeneca, Bristol Myers Squibb, Daichii Sankyo, Eli Lilly, F. Hoffmann–La Roche, Genentech, Gilead, Janssen Pharmaceuticals, Johnson & Johnson, Medical Trends, Medscape, Merck Serono, MSD, Novartis, Peervoice, Pfizer, Regeneron; travel support from AstraZeneca, Janssen Pharmaceuticals, and Roche; and served as an independent member of the board for Grifols Diagnostic Solutions Inc.

: Ethics approval for this T&M study was obtained for each site in accordance with local regulations, where applicable. The study was conducted in compliance with the approved protocol, the applicable principles outlined in Good Pharmacoepidemiology Practice guidelines, and the Declaration of Helsinki (1964 and its later amendments). The WCG IRB served as the master ethics committee for this study. WCG IRB approval was received on 13 Sep 2023 (WCG IRB tracking number: 20234046). Additional IRBs overseeing site-specific approvals are listed in Supplementary Material Table , along with their respective reference identifiers. All HCPs provided written agreements prior to observation. Patients under passive observation verbally consented after reviewing the study’s patient information leaflet. All HCPs and study sites participated voluntarily and retained the right to withdraw from the study at any time and for any reason.