Data collection and confidentiality
Participant data will be collected and entered onto the web-based database REDCap by the local research team. Data will be filed for 10 years as per local policy and then deleted. Data will be monitored by the trial manager for quality and completeness, and missing data will be requested from the participating sites, as per the data monitoring plan. The trial manager will only have access to pseudonymised data on REDCap.