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Article History

Received: 23 May 2025

Accepted: 20 August 2025

First Online: 27 September 2025

Declarations

:

: Institutional Review Board Committee Approvals from Christian Medical College, Vellore1. RIAS study - IRB Min No. 13259 (OBSERVE), approval date: 26.08.20202. RIS study - IRB Min No. 12242 (OBSERVE), approval date: 25.09.20193. RVEIS study - IRB Min No. 11522 (OBSERVE), approval date: 26.09.2018Approvals were also taken from each site where the study was conducted:For RIAS study site EC approvals are:1. Government Medical College, Kozhikode – GMCKKD/RP2021/IEC/11 dated 05/02/20212. Government Medical College, Thiruvananthapuram – HEC.No.02/07/2021/MCT dated 23.1.20213. Jubilee Mission Medical College and Research Institute, Thrissur – 35/20/IEC/JMMC & RI dated 30/10/20204. JSS Medical College and Research Centre, Mysore – JSSMC/IEC/181120/16NCT/2020-21, dated 19.11.20205. Kasturba Medical College, Mangalore – MAHE EC/018/2019 dated 13.11.20196. KLE Prabhakar Kore Hospital and Medical Research Centre, Belagavi – KAHER/IEC/2019-20/D 271219011 dated 27.11.20197. Karnataka Institute of Medical Sciences, Hubballi – KMCRI: 131: 2022-23 dated 25.02.20238. LTMGH, Sion, Mumbai – IEC/377/21 dated 25.05.20219. MGM Medical College and Research Centre, Aurangabad – MGM-ECRHS/2020/117 dated 19.12.202010. Sant Dnyaneshwar Medical Education and Research Centre, Pune – dated 13.08.202211. Dr Shankarrao Chavan Government Medical College and Hospital, Nanded - PSM/IEC/Approval letter//612/23 dated 17/08/2312. M P Shah Government Medical College, Jamnagar - Ref. No. IEC/Certi/l57/05/2020 dated 16-10-202013. Pandit Deendayal University Medical College and Hospital, Rajkot – PDUMCR/IEC/01/2021 dated 28.01.202114. Surat Municipal Institute of Medical Education and Research, Surat – SMIMER/IEC/OUT/No. 09 dated 22.06.202215. B.J. Medical College and Civil Hospital, Ahmedabad – Ref. No. EC Approval/78/2022 dated 27.08.202216. Capital Hospital, Bhubaneswar with 2 satellite sites - No. 22348/MS-2, Bhubaneshwar, dated 16/9/2317. Sardar Vallabhbhai Patel Post Graduate Institute of Pediatrics, Cuttack - No. 22348/MS-2, Bhubaneshwar, dated 16/9/2318. National Institute of Epidemiology and Institute of Child Health and Hospital for Children, ChennaiFor RVEIS study site EC approvals are:1. Rajendra Institute of Medical Sciences, Ranchi with 3 satellite sites – 71 IEC/IAEC/RIMS dated 16.02.20192. Bokaro General Hospital, Bokaro with 1 satellite site – dated 11.02.20193. Kshitij Hospital and Research Center, Hazaribagh with 2 satellite sites – 129 IEC/IAEC/RIMS dated 16.08.20194. Shaheed Nirmal Mahto Medical College, and Hospital, Dhanbad with 2 satellite sites - 128 IEC/IAEC/RIMS dated 16.08.20195. Translational Health Science and Technology Institute (THSTI), Faridabad, Haryana, India was the Central ethical committee for all sites in Jharkhand – THS 1.8.1/(82) dated 03.07.2019For RIS study site EC approvals are:1. Government Medical College, Kozhikode – Ref. No. GMCKKD/ RP 2021/IEC/ 602. Government Medical College, Thiruvananthapuram3. Kerala Institute of Medical Science, Thiruvananthapuram – KIMS/IHEC/APPROVAL/04/2020/02 Dated 12-04-20214. Jubilee Mission Medical College and Research Institute, Thrissur – Ref. No.: 63/19/IEC/JMMC&RI Dated 18-11-20195. Amrita Institute of Medical Sciences, Kochi – IEC-AIMS-2020-PEDS-016 Dated 24-02-20206. Government Medical College, Kottayam – IRB No. 108/2020 Dated 22 March 20217. Jagadguru Sri Shivarathreeshwara (JSS) Medical College and Hospital, Mysore – JSSMC/IEC/ 140120/ 15 NCT/ 2019-20 Dated 10-02-20208. Kasturba Medical College, Manipal – MAHE EC/017/2019 Dated 29-10-20199. Kasturba Medical College, Mangalore – MAHE EC/018/2019 Dated 13-11-201910. Karnataka Lingayat Education Society’s Prabhakar Kore Hospital, Belagavi – Ref: KAHER/IEC/2019-20 Dated 27-12-201911. St Johns Research Institute, St Johns Medical College Hospital, Bangalore – IEC/1/350/2020 Dated 06-05-202012. King Edward (VII) Memorial Hospital and Seth Gordhandas Sunderdas Medical College, Mumbai – IEC(III)/OUT/ 603/2020 Dated 27-11-202013. Lokmanya Tilak Municipal Government Hospital, Sion, Mumbai – Ref.: IEC/53/20 Dated 20-10-202014. Government Medical College, Nagpur – No. 1957 EC/ Pharmac/ GMC/NGP Dated 27/01/202015. King Edward (VII) Memorial Hospital (KEM), Pune – KEMHRC/RVM/EC/ 1922 Dated 30-09-202016. Mahatma Gandhi Mission (MGM) Medical College and Research Centre, Aurangabad – Ref No. MGM-ECRHS/2020/01 Dated 06-02-202017. Pediatric Surgery Center and Post Graduate Institute, Sangli – Dated 25-02-202018. Sir Byramjee Jeejeebhoy (B J) Medical College, Ahmedabad – Ref. No. EC/Approval/07/2020/09/01/202019. M P Shah Government Medical College, Jamnagar – Ref. No. IEC/Certi/ 132/04/2019 Dated 03-12-201920. Medical College and Sir Sayajirao General (SSG) Hospital, Vadodara – Dated 19-02-202021. Pandit Deendayal University Medical College and Hospital, Rajkot with Maa Sharda Childcare, Rajkot as satellite site – Outward No. PDUMCR/IEC/02/2021 Dated 28-01-2021

: Written informed consent was obtained from the parents/guardians of each enrolled participant.

: None.