Ethics approval and consent to participate
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). ClinicalTrials.gov Identifier: NCT03082716 Date: 17/03/2017. 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.