Ethical approval
All procedures performed in this randomized controlled prospective clinical study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the Institutional Ethics and Research Committee of Faculty of Medicine, Assiut University, Assiut, Egypt. Clinical trial registration number is (Clinical Trials.gov Identifier: NCT03158168).