Table 2. Treatment Difference Statistical Significance to Effect Size to and Confidence Interval in Aberrant Behavior Checklist (ABC) Subscales (Total 36 Weeks).
| Analysis and time point | ABC subscale score | ||||
|---|---|---|---|---|---|
| Irritability/Agitation | Lethargy/Social Withdrawal | Stereotypy | Hyperactivity/Noncompliance | Inappropriate Speech | |
| Baseline | |||||
| Drug baseline value (early-start) | 22.9 | 17.4 | 9.4 | 30.7 | 5.6 |
| Placebo baseline value (delayed-start) | 22.6 | 16.6 | 9.3 | 29.0 | 5.6 |
| Double-blind week 12 | |||||
| ABC MMRM LS mean change drug (early-start) | −7.78 | −7.72 | −3.19 | −9.22 | −1.74 |
| ABC MMRM LS mean change placebo (late-start) | −5.29 | −6.68 | −2.15 | −6.49 | −0.74 |
| Treatment difference (95% CI) | −2.49 (−4.66 to −0.32) | −1.03 (−3.00 to 0.93) | −1.04 (−2.20 to 0.12) | −2.72 (−5.36 to −0.09) | −1.00 (−1.77 to −0.22) |
| P value | .03 | .30 | .08 | .04 | .01 |
| Effect size | 0.364 | 0.167 | 0.283 | 0.328 | 0.406 |
| Open-label week 24 (36 weeks total) | |||||
| ABC MMRM LS mean change drug/drug (early-start) | −9.80 | −9.56 | −3.83 | −11.19 | −1.91 |
| ABC MMRM LS mean change placebo/drug (late-start) | −6.73 | −6.99 | −2.59 | −7.62 | −0.56 |
| P value | 0.028 | 0.042 | 0.103 | 0.032 | 0.008 |
| Effect Size | 0.516 | 0.476 | 0.383 | 0.504 | 0.628 |
| 95% CI | (−5.81 to −0.33) | (−5.05 to −0.09) | (−2.72 to 0.25) | (−6.84 to −0.31) | (−2.35 to −0.36) |
Abbreviations: LS, least squares; MMRM, mixed model for repeated measures.