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Authors
de Queiroz, Sarha A. L. https://orcid.org/0009-0005-6998-4751
Guimarães, Deivis O.
Ferreira, Lara A.
Martinelli, Larissa
Werly, Rebeca M. M.
Amorim, Raphaela F.
Holzbach, Lívia B. S. S.
Badaró, Roberto
Santos, Alex A. B.
Vasquez, Elisardo C.
Silva, Racire S.
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Funding
Funding for this research was provided by:
Gon1 Biotech, Vitória, Brazil
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Article History
Received: 19 September 2025
Accepted: 5 January 2026
First Online: 17 January 2026
Declarations
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: This randomized, double-blind, placebo-controlled clinical trial was conducted in accordance with the principles of the Declaration of Helsinki and was approved by the Research Ethics Committee of Vila Velha University (CEP/UVV), Vila Velha, ES, Brazil (CAAE #77402523.6.0000.5064; Opinion No. 6.715.143). Ethical approval was obtained prior to study initiation to ensure full transparency and adherence to international and national research guidelines.Clinical trial registration: Gov.br: CAAE 77402523.6.0000.5064.Registry name: Plataforma Brasil. Registration date: February 7, 2024.ClinicalTrials.gov Identifier: NCT06382909.Registry name: ClinicalTrials.gov. Registration date: March 28, 2024.
: Written informed consent for publication of anonymized data was obtained from the parents or legal guardians of the participants. No personal identifiers are included in this article.
: The authors declare no competing interests.
