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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
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Journal of Translational Medicine

ISSN: 1479-5876

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