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Authors
Thuluva, Subhash https://orcid.org/0000-0002-9099-420X
Gunneri, Subbareddy
Ningaiah, Siddalingaiah
Yerroju, Vijay
Mogulla, Rammohan Reddy
Dhar, Chirag
Thammireddy, Kamal
Desai, Shivani
Paliwal, Piyush
Loka, Chandrudu
Esanakarra, Raju
Narayandas, Spoorthy
Chakravarthy, B. S.
Narayan, Jai Prakash
Mahantshetti, N. S.
Narang, Manish
Karayar, Ramanath Andy
Verma, Savita
Thakkar, Pareshkumar A.
Prabhakar, Jog Pramod
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Article History
Received: 10 February 2026
Accepted: 7 September 2026
First Online: 12 September 2026
Declarations
Human ethics approval and consent to participate: The study was conducted according to the guidelines of the Declaration of Helsinki and in accordance with the local legislation and institutional requirements. The study was approved by each of the ethics committees with oversight over the 31 clinical sites participating in this study (Appendix , Supplementary Information), including the Institutional Ethics Committee of All India Institute of Medical Sciences (ECR/534/Inst/OD/2014/RR-20). Written informed consent for participation in this study was provided by the participants’ parents/ LARs before starting the study procedure.
Consent for publication: Not applicable. This manuscript does not contain any individual person’s details, images, or videos. Hence, consent for publication is not applicable in this case.
Competing interests: ST, SG, SN, VY, RRM, CD, KT, SD, PP, CL, RE, and SN are or were employees of Biological E. Limited. None of the authors hold, or have held, any equity or stock in the company. BSC, JPN, NSM, MN, RAK, SV, PAT, and JPP were principal investigators on the study and received research funding support from Biological E. Limited. All authors declare no other relevant competing interest.
