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Any substantive modifications pertaining to the study protocol, be it eligibility criteria, intervention methodologies, outcome measures, or analytical approaches, will be executed under the vigilant oversight and endorsement of the respective review board. All endeavors undertaken in this trial with human participants shall align scrupulously with the rigorous ethical tenets set forth by both the institutional\/national research committees and the 1964 Helsinki Declaration, inclusive of subsequent amendments or analogous ethical benchmarks. Prior to their enrolment and allocation, explicit written consents shall be procured from all participating individuals.","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 that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"63"}}