Ethics approval and consent to participate
MAY
This study was approved by the Ethics Committee of Aswan University Hospital (approval number: aswu/548/7/2021; registration date: 06/07/2021) and registered on ClinicalTrials.gov (NCT05341154) (22/04/2022). It was held between May 2022 and May 2023 and followed the Consolidated Standards of Reporting Trials guidelines. The study’s objectives and risks were explained to participants, and they signed written informed consent. All methods were carried out in accordance with the Helsinki Declaration of 1964 and subsequent amendments.