Table 3. Non-inferiority statistical analysis of body weight (primary objective).
| ITT population | ||
|---|---|---|
| Size | n = 60 | |
| Initial BW (arithmetic mean, kg) | 62.05 | |
| SEM | 1.10 | |
| 95% CI | 58.84–64.25 | |
| 10% non inferiority margin | 6.21 | |
| PP Population | ||
| Group | Experimental | Control |
| Size | n = 29 | n = 29 |
| Initial BW (arithmetic mean, kg) | 62.29 | 61.38 |
| SEM | 1.73 | 1.45 |
| 95% CI | 58.75–65.84 | 58.34–64.35 |
| Final BW (arithmetic mean, kg) | 62.16 | 61.01 |
| SEM | 1.80 | 1.60 |
| 95% CI | 58.46–65.85 | 57.73–64.29 |
| Mean difference | 1.15 | |
| SEM | 2.41 | |
| 95% CI | 3.68–5.98 | |
| Is the upper boundary of 95% CI below the 10% margin? (confirming non inferiority)* | Yes |
ITT: Intention to treat population.
PPP: Per protocol population.
* The non-inferiority is confirmed when the upper boundary of the 95% CI of the difference is lower than the non-inferiority margin.
