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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:\n                      For RIAS study site EC approvals are:\n                      1. Government Medical College, Kozhikode \u2013 GMCKKD\/RP2021\/IEC\/11 dated 05\/02\/20212. Government Medical College, Thiruvananthapuram \u2013 HEC.No.02\/07\/2021\/MCT dated 23.1.20213. Jubilee Mission Medical College and Research Institute, Thrissur \u2013 35\/20\/IEC\/JMMC & RI dated 30\/10\/20204. JSS Medical College and Research Centre, Mysore \u2013 JSSMC\/IEC\/181120\/16NCT\/2020-21, dated 19.11.20205. Kasturba Medical College, Mangalore \u2013 MAHE EC\/018\/2019 dated 13.11.20196. KLE Prabhakar Kore Hospital and Medical Research Centre, Belagavi \u2013 KAHER\/IEC\/2019-20\/D 271219011 dated 27.11.20197. Karnataka Institute of Medical Sciences, Hubballi \u2013 KMCRI: 131: 2022-23 dated 25.02.20238. LTMGH, Sion, Mumbai \u2013 IEC\/377\/21 dated 25.05.20219. MGM Medical College and Research Centre, Aurangabad \u2013 MGM-ECRHS\/2020\/117 dated 19.12.202010. Sant Dnyaneshwar Medical Education and Research Centre, Pune \u2013 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 \u2013 PDUMCR\/IEC\/01\/2021 dated 28.01.202114. Surat Municipal Institute of Medical Education and Research, Surat \u2013 SMIMER\/IEC\/OUT\/No. 09 dated 22.06.202215. B.J. Medical College and Civil Hospital, Ahmedabad \u2013 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, Chennai\n                      For RVEIS study site EC approvals are:\n                      1. Rajendra Institute of Medical Sciences, Ranchi with 3 satellite sites \u2013 71 IEC\/IAEC\/RIMS dated 16.02.20192. Bokaro General Hospital, Bokaro with 1 satellite site \u2013 dated 11.02.20193. Kshitij Hospital and Research Center, Hazaribagh with 2 satellite sites \u2013 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 \u2013 THS 1.8.1\/(82) dated 03.07.2019\n                      For RIS study site EC approvals are:\n                      1. Government Medical College, Kozhikode \u2013 Ref. No. GMCKKD\/ RP 2021\/IEC\/ 602. Government Medical College, Thiruvananthapuram3. Kerala Institute of Medical Science, Thiruvananthapuram \u2013 KIMS\/IHEC\/APPROVAL\/04\/2020\/02 Dated 12-04-20214. Jubilee Mission Medical College and Research Institute, Thrissur \u2013 Ref. No.: 63\/19\/IEC\/JMMC&RI Dated 18-11-20195. Amrita Institute of Medical Sciences, Kochi \u2013 IEC-AIMS-2020-PEDS-016 Dated 24-02-20206. Government Medical College, Kottayam \u2013 IRB No. 108\/2020 Dated 22 March 20217. Jagadguru Sri Shivarathreeshwara (JSS) Medical College and Hospital, Mysore \u2013 JSSMC\/IEC\/ 140120\/ 15 NCT\/ 2019-20 Dated 10-02-20208. Kasturba Medical College, Manipal \u2013 MAHE EC\/017\/2019 Dated 29-10-20199. Kasturba Medical College, Mangalore \u2013 MAHE EC\/018\/2019 Dated 13-11-201910. Karnataka Lingayat Education Society\u2019s Prabhakar Kore Hospital, Belagavi \u2013 Ref: KAHER\/IEC\/2019-20 Dated 27-12-201911. St Johns Research Institute, St Johns Medical College Hospital, Bangalore \u2013 IEC\/1\/350\/2020 Dated 06-05-202012. King Edward (VII) Memorial Hospital and Seth Gordhandas Sunderdas Medical College, Mumbai \u2013 IEC(III)\/OUT\/ 603\/2020 Dated 27-11-202013. Lokmanya Tilak Municipal Government Hospital, Sion, Mumbai \u2013 Ref.: IEC\/53\/20 Dated 20-10-202014. Government Medical College, Nagpur \u2013 No. 1957 EC\/ Pharmac\/ GMC\/NGP Dated 27\/01\/202015. King Edward (VII) Memorial Hospital (KEM), Pune \u2013 KEMHRC\/RVM\/EC\/ 1922 Dated 30-09-202016. Mahatma Gandhi Mission (MGM) Medical College and Research Centre, Aurangabad \u2013 Ref No. MGM-ECRHS\/2020\/01 Dated 06-02-202017. Pediatric Surgery Center and Post Graduate Institute, Sangli \u2013 Dated 25-02-202018. Sir Byramjee Jeejeebhoy (B J) Medical College, Ahmedabad \u2013 Ref. No. EC\/Approval\/07\/2020\/09\/01\/202019. M P Shah Government Medical College, Jamnagar \u2013 Ref. No. IEC\/Certi\/ 132\/04\/2019 Dated 03-12-201920. Medical College and Sir Sayajirao General (SSG) Hospital, Vadodara \u2013 Dated 19-02-202021. Pandit Deendayal University Medical College and Hospital, Rajkot with Maa Sharda Childcare, Rajkot as satellite site \u2013 Outward No. PDUMCR\/IEC\/02\/2021 Dated 28-01-2021","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}},{"value":"Written informed consent was obtained from the parents\/guardians of each enrolled participant.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent"}},{"value":"None.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}}]}}