Primary Outcome
The ITT analysis of the hospitalization rate after 12 months included 510 participants. Due to the pandemic situation, the mean observation time was longer in the intervention group; therefore, an adjustment was made for the duration of observation. There was no significant difference in the adjusted mean (SD) number of hospitalizations between the intervention group (0.98 [1.72]) and the control group (0.99 [1.53]). Other results for the primary outcome are summarized in 