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Table 3 Mean monthly upper respiratory tract infection and acute otitis media rate in the study population, according to treatment group

From: A randomized, placebo-controlled, double-blinded, single-centre, phase IV trial to assess the efficacy and safety of OM-85 in children suffering from recurrent respiratory tract infections

Infection Month
1 2 3 4 5 6
URTI
 Group A treatment 3 months (n = 100)
  Mean 0.37 0.31* 0.28* 0.27* 0.31* 0.33
  SD 0.37 0.36 0.46 0.31 0.49 0.61
 Group B placebo (n = 109)
  Mean 0.43 0.46 0.43 0.58 0.61 0.65
  SD 0.49 0.58 0.52 0.46 0.61 0.55
 Group C treatment 6 months (n = 37)
  Mean 0.39 0.33* 0.31* 0.28* 0.30* 0.29
  SD 0.25 0.30 0.22 0.24 0.19 0.28
AOM
 Group A treatment 3 months (n = 100)
  Mean 0.37 0.29* 0.27* 0.24* 0.26* 0.24*
  SD 0.44 0.55 0.40 0.53 0.44 0.41
 Group B placebo (n = 109)
  Mean 0.46 0.52 0.49 0.56 0.66 0.78
  SD 0.51 0.63 0.60 0.66 0.72 0.73
 Group C treatment 6 months (n = 37)
  Mean 0.35 0.31* 0.28* 0.26* 0.27* 0.25*
  SD 0.31 0.28 0.30 0.31 0.25 0.33
  1. AOM: acute otitis media; URTI: upper respiratory tract infection
  2. * p < 0.05 vs placebo; no other significant differences between the groups