Table 1.
Study Patient's Baseline Characteristics
| Variable | ITT population |
PP population |
||||
|---|---|---|---|---|---|---|
| Control (n = 50) | Experimental (n = 50) | p Value | Control (n = 47) | Experimental (n = 46) | p Value | |
| Gender (male) | 34 (68.0%) | 18 (36.0%) | 0.001** | 33 (70.2%) | 17 (37.0%) | 0.001* |
| Age (yr) | 8.30 ± 1.64 | 8.58 ± 1.79 | 0.417** | 8.28 ± 1.61 | 8.57 ± 1.83 | 0.422** |
| Weight (kg) | 25.12 ± 5.31 | 27.28 ± 6.50 | 0.072** | 24.80 ± 5.18 | 27.28 ± 6.67 | 0.048** |
| Height (cm) | 124.14 ± 9.26 | 126.17 ± 10.61 | 0.311** | 123.86 ± 9.10 | 125.97 ± 10.91 | 0.314** |
The data are expressed as the mean ± SD for the FO and placebo group baseline characteristics in ITT and PP population.
p Values are derived from Chi-square test. **p Values are derived from independent t test (comparing between groups).
ITT, intention to treat; PP, per protocol.