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Baseline characteristics (ITT population)
| Total | Probi Defendum® | Placebo | |
|---|---|---|---|
| Children randomised, n (%) | 131 (100) | 63 (48.1) | 68 (51.9) |
| Males, n (%) | 75 (57.2) | 32 (50.8) | 43 (63.2) |
| Females, n (%) | 56 (42.7) | 31 (49.2) | 25 (36.8) |
| Age in years. mean (SD) | 3.1 ± 1.4 | 3.1 ± 1.4 | 3.1 ± 1.4 |
| 1–2 years old, n (%) | 48 (36.6) | 24 (38.1) | 24 (35.3) |
| 3–4 years old, n (%) | 54 (41.2) | 24 (38.1) | 29 (42.6) |
| 5–6 years old, n (%) | 30 (22.9) | 15 (23.8) | 15 (22.1) |
