Participant flow
PMBL
62 children were enrolled in the study. After excluding 8 patients who did not meet the inclusion criteria or met at least one exclusion criterion and 4 patients who did not agree to participate in the study, 25 children were randomized to the PMBL group and 25 to the placebo group. A total of 41 children completed the trial, 21 in the PMBL group and 20 in the placebo group (Patient flowchart (presented in accordance with the Consolidated Standards of Reporting Trials guidelines). PMBL, polyvalent mechanical bacterial lysate; ITT, intent-to-treat.Baseline overall characteristics of patients.PMBL, polyvalent mechanical bacterial lysate.