Outcomes
AOM
SECONDARY, COVID-19 INFECTION, COMPLICATION
The primary outcome was the proportion of children with at least 1 episode of AOM requiring antimicrobial therapy confirmed from the electronic national medical record and prescription registerThe secondary outcomes retrieved from the electronic national medical record and prescription registerExploratory post hoc analyses, added to the statistical analysis plan after study initiation but before completion of other data analyses, were conducted for the proportion of children with AOM with a complication, the number of AOM episodes with a complication, the proportion of children with tympanostomy tube insertion or adenoidectomy, the proportion of children with respiratory symptoms leading to SARS-CoV-2 testing, the proportion of children with a COVID-19 infection or a positive SARS-CoV-2 test result, and the number of days of a child’s absence from day care per PYR. All exploratory outcomes were reported within 6 months of randomization.