Table 3. Conners 3–PS and WFIRS–P Results by Treatment Group and Domain.

Conners 3–PS		Placebo		SPN-812
		n = 96		400-mg/day n = 99		600-mg/day n = 97
Composite T-score
Baseline, Mean ± SD (absolute value)		73.1 ± 8.91		73.2 ± 8.87		73.9 ± 8.82
CFB at EOS
LS mean ± SE		–5.6 ± 0.89		–7.5 ± 0.87		–6.9 ± 0.88
Difference of LS mean (± SE) (vs. placebo)		–		–1.9 ± 1.26		–1.3 ± 1.25
95% CI of difference		–		(–4.3, 0.6)		(–3.7, 1.2)
p-value (vs. placebo)		–		0.1377		0.3130
Content Scale T-score
CFB at EOS, LS mean ± SE
Inattention		–6.1 ± 1.27		–9.5 ± 1.24		–9.6 ± 1.28
Hyperactivity		–7.1 ± 1.39		–8.9 ± 1.36		–8.5 ± 1.38
Learning Problems		–4.4 ± 1.08		–5.8 ± 1.05		–7.0 ± 1.07
Executive Functioning		–6.2 ± 1.10		–9.3 ± 1.08*		–5.8 ± 1.11
Defiance/Aggression		–4.9 ± 1.39		–5.4 ± 1.35		–5.7 ± 1.38
Peer Relations		–5.7 ± 1.45		–6.0 ± 1.42		–4.8 ± 1.45
WFIRS–P		Placebo		SPN-812
		n = 96		400-mg/day n = 99		600-mg/day n = 97
Total Average Score
Baseline, Mean ± SD (absolute value)		0.97 ± 0.480		0.96 ± 0.442		0.99 ± 0.450
CFB at EOS
LS mean ± SE		–0.23 ± 0.035		–0.32 ± 0.034		–0.23 ± 0.035
Difference of LS mean (± SE) (vs. placebo)		–		–0.09 ± 0.049		–0.00 ± 0.050
95% CI of difference		–		(–0.19, 0.01)		(–0.10, 0.10)
P value (vs. placebo)		–		0.0698		0.9756
Domain Average Score
CFB at EOS, LS mean ± SE
Family		–0.30 ± 0.053		–0.42 ± 0.052		–0.26 ± 0.053
Self-concept		–0.26 ± 0.065		–0.33 ± 0.064		–0.13 ± 0.064
School		–0.32 ± 0.059		–0.44 ± 0.057		–0.36 ± 0.059
Life Skills		–0.23 ± 0.052		–0.31 ± 0.052		–0.24 ± 0.052
Social Activities		–0.22 ± 0.049		–0.29 ± 0.048		–0.21 ± 0.048
Risky Activities		–0.08 ± 0.025		–0.15 ± 0.025		–0.09 ± 0.025

LS means, 95% CIs and p-values are from ANCOVA model with baseline and treatment as fixed independent variables. *p < 0.05.

ANCOVA, analysis of covariance; CFB, change from baseline; CI, confidence interval; Conners 3–PS, Conners 3–Parent Short Form; LS, least squares; SD, standard deviation; SE, standard error; WFIRS–P, Weiss Functional Impairment Rating Scale–Parent.