Safety outcomes
ADVERSE EVENTS, EVENTS
The number and percentage of PwD and CGs who experience adverse events will be summarised across the intervention period (i.e. randomisation to 90-days post-randomisation), the follow-up period (i.e. 90-days post-randomisation to 180-days post-randomisation) and study period (i.e. randomisation to 180 days post-randomisation) by each intervention group. The total number of events will be reported for the PwD and CG separately.