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Ltd., Japan (Fuji). Pankaj Negi and Megha Marwah are employed by AstaReal India Pvt. Ltd, Karen A. Hecht is employed by AstaReal Inc. and Vincent Wood is employed by AstaReal Singapore Pte Ltd, which are subsidiaries of Fuji. Austin E. Bach, Jeffry Gerson and Milton M. Hom have nothing to disclose. Joerg Schnackenberg was an employee of Fuji at the time the study was initiated. He is now affiliated with NIRx Medical Technologies, Tokorozawa, Japan. Sonal Raote and Shalini Srivastava are employed by Vedic Lifesciences, a contract research organization engaged by Fuji.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"The study was approved and monitored by the Institutional Ethics Committee at four centers included in this trial in India (Jaipur National University Institute for Medical Sciences and Research Centre [ECR\/905\/Inst\/RJ\/2017\/RR-20], Rajasthan; Institutional Ethics Committee Aman Hospital & Research Centre [ECR\/857\/Inst\/GJ\/2016\/RR-19], Gujarat; Harmony Ethical Research Committee (HERC) Shree Hospital [ECR\/1411\/Inst\/MH\/2020], Mumbai; Maharashtra and Muktai Ethics Committee [ECR\/251\/Inst\/Maha\/2013\/RR-19], Nashik, Maharashtra). It was conducted in compliance with the Declaration of Helsinki, International Conference on Harmonization (ICH) recommendation on Good Clinical Practice (GCP)\u2014E6 (R2), 2016, and National Ethical Guidelines for Biomedical and Health Research involving Human Participants, 2017 issued by Indian Council of Medical Research (ICMR), India. The study was registered on ClinicalTrials.gov (NCT05602402) and the Clinical Trials Registry India (CTRI\/2022\/10\/046606). For participants below 12\u00a0years, consent was through parents alone, while for those between 12 and 14\u00a0years, both parents and participants provided consent. All participants provided informed consent for the anonymous use of their data in scientific analyses and publications, following a detailed explanation of the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}