Materials and methods
This was a prospective, double-blinded randomized controlled trial in two parallel groups conducted in two tertiary referral hospitals. The study protocol was carried out in accordance with relevant guidelines and regulations and was approved by the Ethics Committee of Medical Faculty Universitas Indonesia (KET-99/UN2.F1/ETIK/PPM.00.02/2021) and Universitas Syiah Kuala – Zainoel Abidin Hospital (122/EA/FK-RSUDZA/2021) prior to the study. The study was also registered at ClinicalTrial.gov (NCT04951024; 06/07/2021). Informed consent for study participation was obtained from all patients and/or their legal guardian(s). No violation of the Helsinki Declaration occurred during the informed consent and data acquisition period.