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Table 1 Baseline characteristics of children enrolled in the trial, by randomization 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

Characteristic Group A
treatment, 3 months (n = 123)
Group B
placebo
(n = 124)
Group C
treatment, 6 months
(n = 41)
N % n % n %
Sex
 Male 72 58.5 81 65.3 26 63.4
 Female 51 41.5 43 34.7 15 36.6
Age at baseline (years)
 1–2 63 51.2 46 37.1 16 39.0
 3–4 41 33.3 50 40.3 12 29.3
 5–6 19 15.5 28 22.6 13 31.7
 Mean ± SD 3.6 ± 1.6   3.7 ± 1.5   3.8 ± 1.7  
Ethnic group
 Caucasian 104 84.5 102 82.3 36 87.8
 Any other 19 15.5 22 17.7 5 12.2
Residence
 Milan City 59 48.0 72 58.1 26 63.4
 Outside Milan 64 52.0 52 41.9 15 36.6
Education (parents)a
 Primary/secondary 9 7.3 9 7.4 4 9.8
 High school degree (at least one parent) 60 48.8 43 35.2 14 34.1
 University degree (at least one parent) 54 43.9 70 57.4 23 56.1
Passive smoking (from parents)
 No 81 66.4 89 71.8 26 63.4
 Yes (at least one parent) 41 33.6 35 28.2 15 36.6
No. of siblings
 0 28 22.8 31 25.0 13 31.7
 1 75 61.0 73 58.9 20 48.8
 2+ 20 16.3 20 16.1 8 19.5
Attending nursery/primary school
 No 18 14.6 9 7.3 5 12.2
 Yes 105 85.4 115 92.7 36 87.8
History of atopy
 No 96 78.1 95 76.6 32 78.1
 Yes 27 21.9 29 23.4 9 21.9
History of recurrent wheezing
 No 105 85.4 103 83.1 35 85.4
 Yes 18 14.6 21 16.9 6 14.6
  1. No statistically significant differences were detected between groups
  2. aThe sums may not add up to the total because of missing values