Date

2023-11-27

Protocol

Protocol changed

Item Changed

IPD sharing plan description

Previous Version

NA

Next Version

All individual participant data collected during the trial, will be shared after de-identification. Other documents available include : study protocol, analysis plan, clinical study report. Data will be available from the date of publication and ending 5 years following first publication. Data will be shared with anyone on a reasonable request to the corresponding author. Data will be shared for any analytical purpose. Proposals should be directed to chamila@kln.ac.lk. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years from the time of publication on the Faculty of Medicine, University of Kelaniya, Sri Lanka repository.