Primary and Secondary Outcomes in 
AOM, perforation, mastoiditis
SECONDARY, ACUTE OTITIS MEDIA, COMPLICATION, MASTOIDITIS
Abbreviations: AOM, acute otitis media; PYR, person-years at risk.The interpretation of this statistical analysis should be done with caution, as this study was not designed for subgroup analyses.Monthly questionnaires used for the secondary outcomes were available for 679 (82.1%) children at 1 month, 653 (79.0%) at 2 months, 617 (74.6%) at 3 months, 600 (72.6%) at 4 months, 576 (69.6%) at 5 months, and 553 (66.9%) at 6 months.Data were available from 414 children in the placebo group and 413 in the Complication was defined as perforation of the tympanic membrane. None of the children had mastoiditis. Includes 24 children in the placebo group and 34 in the Data were available from 273 children in the placebo group and 270 in the Data were available from 381 children in the placebo group and 375 in the 