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The trial was registered at the Registry of Clinical Trials as IRCT20201107049296N3, First Trial Registration: 11\/09\/2022, Access: ) and according to the CONSORT. reporting guidelines. By the Helsinki Convention, and after obtaining informed consent from the patients (informed consent was obtained from parents for patients under the age of consent and from the patients themselves for those over the age of consent), the patients were included in the study. A safety committee that operates autonomously receives annual updates regarding the progress of the study, the occurrence of severe adverse events, and their characteristics. This committee concluded that there were no reasonable grounds to terminate the study.","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":"344"}}