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Any significant modifications to the research protocol will only be made under the strict supervision and explicit authorization of the ethics committee. The conduct of all trial procedures will adhere strictly to the ethical standards mandated by institutional and national research committees, in alignment with the Declaration of Helsinki (version: October 2013, Fortaleza, Brazil) and its subsequent amendments, as well as other globally recognized ethical standards in clinical research. Informed consent will be obtained from all participants or their legal guardians before any protocol-related activities commence. This process will be voluntary and informed, with participants and their guardians retaining the right to revoke consent at any point without justification. Throughout all phases of the study - pre-operative, intra-operative, and post-operative - the provision of non-trial related treatments will conform to standard care protocols established at each participating site. Comprehensive documentation of primary and secondary outcomes will be included in the final clinical trial report, which will adhere to CONSORT guidelines to ensure high-level scientific communication. The results of the trial will be disseminated regardless of the outcome (positive, negative, or inconclusive) to maintain transparency and contribute to the broader scientific knowledge base. Findings will be submitted for publication in a peer-reviewed international journal and presented at national and international conferences to foster academic discussion and peer engagement.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"1276"}}