Table 4.
Summary of Vineland-3 Scores (change from baseline).
| Measure | Placebo | SB-121 | SB-121 minus placebo | Approximate treatment effect size | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| LS mean | SEM | P-value | LS mean | SEM | P-value | LS mean | SEM | P-value | ||
| Vineland adaptive behavior composite score | 1.05 | 2.06 | 0.61 | 4.87 | 2.06 | 0.03 | 3.81 | 3.21 | 0.26 | 0.32 |
| Vineland socialization domain | − 0.14 | 2.79 | 0.96 | 5.57 | 2.79 | 0.06 | 5.71 | 4.81 | 0.26 | 0.32 |
| Vineland daily living skills domain | 0.53 | 2.42 | 0.83 | 5.37 | 2.42 | 0.04 | 4.84 | 3.14 | 0.15 | 0.41 |
| Vineland communication domain | 2.65 | 3.85 | 0.50 | 2.32 | 3.85 | 0.55 | − 0.33 | 5.74 | 0.96 | − 0.02 |
LS least squares, SEM standard error of the mean.
For each measurement, the response was the difference between post-dose and pre-dose value. The adjusted, or LS mean for each treatment (SB-121 or placebo) and its standard error were derived from the model. The LS means differences between SB-121 and placebo (SB-121 LS mean minus Placebo LS mean) and their standard errors were also assessed. Statistical significance was set at a two-sided alpha = 0.05 and no adjustment was made for multiple comparisons. An approximate treatment effect was derived from the difference between the LS means for the SB-121 and placebo change from baseline and its standard error. All statistical analyses were conducted using SAS® statistical software version 9.4 for Windows (SAS Institute Inc., Cary, NC).