Ethical considerations
RECRUITMENT
The study was approved prior to patient recruitment by the Institutional Review Board of King Faisal Specialist Hospital and Research Center, Jeddah (Approval# 2016–8). All study activities and methods were in accordance with ICH-GCP and local regulatory guidelines. Informed consent for retention and use of patient data for research purposes was obtained from their guardians at the time of the procedure consent before randomization. The patients or their guardians retained the right to withdraw from the study at any time.