CONSORT 2010 checklist of information to include when reporting a randomised trial*.
SBKS
(DOC)Click here for additional data file.(PDF)Click here for additional data file.The authors would like to thank the parents of all study subjects for consenting to participate in this research study; all the investigators and their site staff of the Departments of Paediatrics, Mysore Medical College, Mysore, KLES Dr Prabhakar Kore Hospital, Belagavi, Government Victoria Hospital, Visakhapatnam, Prakhar Hospital Pvt. Ltd., Kanpur, SBKS Medical College, Vadodara, Christian Medical College & Hospital, Ludhiana, Department of Pharmacology, SRM Medical College Hospital, Chennai, and Department of Community Medicine, Kalinga Institute of Medical Sciences, Bhubaneswar; the staff of Zifo Technologies, India (for data management) and Global Clinical Immunology, Sanofi, Swiftwater, USA (for laboratory analysis).