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Version 1.0 of the protocol was approved on 23rd March 2024 vide approval number 2024\/TMC\/310\/IRB814 and version 2.0 amendment was approved on 13th August 2024 vide. Approval number 2024\/TMC\/310\/IRB814.All patients will be provided with a patient information leaflet which will detail the study purpose, procedures, harms and expected benefits. Written informed consent will be obtained and signed by an independent witness as well as the PI or Co-PI or designated authorised person(s) including trial nurses. The date, time and the name of the person obtaining the consent will be recorded in the medical records.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate\u00a0{24}"}},{"value":"The model consent form and patient information sheet for the trial is included as Appendix I. Publications from this study will not have identifying information related to patient and patient data will be reported in aggregate.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication\u00a0{32}"}},{"value":"The authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests\u00a0{28}"}}],"article-number":"408"}}