Study sponsorship and coordination
This was an investigator-led study without formal sponsorship as no institution (national or international) was identified for this purpose. The pharmaceutical company, Cipla (Mumbai, India) generously provided Rs 500,000 (USD 6730) as an unrestricted grant to support a part-time salary of a study coordinator who assisted the Chief Investigator (RDh). Cipla had no role in the trial design, data collection, data analysis, data interpretation, or writing of the manuscript. The costs related to the secure AWS server hosting the eCRF app (USD 1000) were borne by JK, RD and SDG. JK, RD, RDh, and SDG had full access to all the data at the end of the study, and all authors had individual responsibility for the decision to submit for publication. The corresponding author (SDG) had the final responsibility to submit the paper for publication.