Vázquez-Frias, Rodrigo http://orcid.org/0000-0003-1278-073X
Consuelo-Sánchez, Alejandra
Acosta-Rodríguez-Bueno, Carlos Patricio
Blanco-Montero, Andrés
Robles, Daniel Casas
Cohen, Vanessa
Márquez, Daniel
Perez, Marcos III
Funding for this research was provided by:
Sanofi
Article History
Accepted: 7 September 2022
First Online: 16 November 2022
Declarations
:
: Open access was funded by Sanofi. This study was funded by Sanofi.
: Rodrigo Vázquez-Frias has received research grants from Sanofi; received consulting fees from BioGaia, Carnot, Nestle, and Nestle Nutrition Institute; and has received speaker honorarium from Abbot Pharmaceuticals, BioGaia, Carnot, Ferrer, Nestle, Nestle Nutrition Institute, and Schwabe Pharma. Alejandra Consuelo-Sánchez has participated in advisory boards for Sanofi and academic events organized by Sanofi; received some payment for conducting procedures in this study (as per his previous contract with his hospital); and has assisted in National and International Congresses (pre-2019). Carlos Patricio Acosta-Rodríguez-Bueno declares no conflict of interest. Andrés Blanco-Montero received a payment as part of the research team that conducted this study. Daniel Casas Robles received payment for participating in this study research. Vanessa Cohen, Daniel Márquez, and Marcos Perez III are current employees of Sanofi and may hold shares and/or stock options in the company.
: The protocol was approved by Independent Ethics Committees and Research Committees. The study was conducted in accordance with all applicable laws, rules, and regulations and with the Declaration of Helsinki and the International Council for Harmonisation guidelines for Good Clinical Practice.
: Parents/legal guardians provided written, informed consent on behalf of their child at the time of enrollment. An informed assent form was signed by the patient, if applicable (age of assent was determined by the Independent Ethics Committees and Research Committees).
: Not applicable.
: Qualified researchers may request access to patient-level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient-level data will be anonymized and study documents will be redacted to protect the privacy of our trial participants. Further details on Sanofi’s data sharing criteria, eligible studies, and process for requesting access can be found at ExternalRef removed.
: Not applicable.
: Rodrigo Vázquez-Frias, Alejandra Consuelo-Sánchez, Carlos Patricio Acosta-Rodríguez-Bueno, Vanessa Cohen, Daniel Márquez, and Marcos Perez III contributed to study conception and methodology. Validation was performed by Rodrigo Vázquez-Frias. Investigations were conducted by Rodrigo Vázquez-Frias, Alejandra Consuelo-Sánchez, Carlos Patricio Acosta-Rodríguez-Bueno, Andrés Blanco-Montero, and Daniel Casas Robles. Carlos Patricio Acosta-Rodríguez-Bueno, Vanessa Cohen, Daniel Márquez, and Marcos Perez III contributed resources. Data curation was provided by Alejandra Consuelo-Sánchez, and Daniel Casas Robles. Supervision was provided by Rodrigo Vázquez-Frias, Vanessa Cohen, Daniel Márquez, and Marcos Perez III. Vanessa Cohen, Daniel Márquez, and Marcos Perez III contributed to project administration and funding acquisition. All authors contributed to writing (review and edit) of the paper, and read and approved the final manuscript.