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Article History

Received: 24 July 2025

Accepted: 18 November 2025

First Online: 12 December 2025

Declarations

:

: Catherine Bravo, Christèle Augard, and Laurent Coudeville are employees of Sanofi and may hold shares and/or stock options in the company. Carlos Espul, Héctor Horacio Cuello, Ana Saravia, and Marcos Emmanuel Vargas do not have any conflict of interest to report.

: The study was undertaken in compliance with the International Conference on Harmonisation Good Clinical Practice guidelines and the principles of the Declaration of Helsinki. Informed consent was obtained from the participants’ parents (or legal guardians) before any study procedures were performed, as was informed assent from participants from the age of 7 years. The protocol and any amendments were approved by the Ministry of Health in the Mendoza Province and the central hospital of Mendoza Independent Ethics Committee/Institutional Review Board (VV-TMF-562262 AR 001 IRB or IEC Approval 2008-07-03 | VV-TMF-562262 | 1.0, subsequently undated as act numbers 8/2008, 5/2011, 1/2013, and 14/2017), and notified by the Provincial and National health authorities. Due to the changes in regulations at the province and national levels, the extension of the study to year 15 was approved by the ethics committee at province level and registered at the Mendoza Province Health Authority following the approval of hospital’s ethics committee (Act Number 14/2017).