Ethical approval
PRS
RECRUITMENT
The study protocol was approved by the Ethical Committee in faculty of medicine, Beni- Suef university, Egypt; approval number (0006240). All Helsinki Declaration research ethics principles were complied with. An informed written consent was obtained from each patient at recruitment. The clinical trial was registered in the “Clinical Trials.gov Protocol Registration and Results System (PRS);” registration number is (NCT05632185/2022) and the full date of first registration is 20/11/2022. Available at: