Dvorkin, Julia
Sosa, Emiliano
Vodicka, Elizabeth
Baral, Ranju
Sancilio, Andrea
Dueñas, Karina
Rodriguez, Andrea
Rojas-Roque, Carlos
Carruitero, Patricia B.
Polack, Fernando P.
Pecenka, Clint
Libster, Romina
Caballero, Mauricio T.
Article History
Received: 25 September 2023
Accepted: 24 January 2024
First Online: 10 February 2024
Declarations
:
: This study, observational in design, used retrospective data, and was conducted in accordance with the amended Helsinki Declaration, the International Guidelines for Ethical Review of Epidemiological Studies, and Argentinean laws on data protection and patients’ rights. This study implies the use of pseudonymised individual data, using double dissociation (i.e., in the original data source and once data are stored in the database) which impedes patients re identification. The institutional review boards at each participating hospital, the Province of Buenos Aires, and Vanderbilt University approved the study. Informed consent was obtained from all participating parents or guardians.
: Not applicable.
: Dr. Polack reports grants and personal fees from JANSSEN, PFIZER, SANOFI, and MERCK, outside the submitted work. Dr. Libster reports grants and/or personal fees from Merck, Pfizer, Janssen outside the submitted work. Elisabeth Vodicka was employed at PATH during her collaborations on this study; she is currently an employee of Pfizer. The rest of the authors declares no competing interests.