A randomised controlled trial to compare the efficacy, safety, and tolerability of low dose, short course primaquine in adults with uncomplicated P. vivax malaria in two hospitals in India.

"Declarations Ethics approval and consent to participate {24}ICMR- National Institute of Malaria Research has obtained approval from the Institutional Ethics Committee (IEC) with relevant documents after Scientific Advisory Committee (SAC) approval. Ethics approval has been obtained from both site ethics committees as well. The proposal has also been submitted for the Health Ministry Screening Committee’s (HMSC) approval. The trial has been registered online prospectively through the Clinical Trial Registry of India (CTRI) after obtaining the approval of the IEC and receiving exemption from the Drug Controller General of India. The study will be conducted in accordance with Good Clinical Practice (GCP), all applicable subject privacy requirements, and the ethical principles that are outlined in the Declaration of Helsinki 2008. Consent for publication {32}This manuscript does not contain individual personal data from patients they will be presented in reports of the trial results. Informed consent materials are available, on request, from the corresponding author. Competing interests {28}The authors declare they have no competing interests. Competing interests {28} The authors declare they have no competing interests."

"Funding {4} Infectious Diseases Data Observatory, University of Oxford, New Richards Building, Old Road Campus, Roosevelt Drive, Oxford, OX3 7LG, UK through a grant from the Bill and Melinda Gates Foundation to PJG (grant number: INV-004713). The funders had no role in the design or conduct of the study."

"Trial registration Trial is registered on CTRI portal, Registration No: CTRI/2022/12/048283."