Date

2025-06-23

Protocol

Protocol changed

Item Changed

1. Target number/sample size; 2. Countries of recruitment

Previous Version

1. 500 subjects from Sri Lanka (250 in each arm); 2. Australia, Japan, Netherlands, Sri Lanka, Taiwan, Province of China, United Kingdom

Next Version

1. Globally 1500; 2. Australia, Brazil, Georgia, Malaysia, Netherlands, Nigeria, Singapore, Sri Lanka