Table 2.

Results of Analysis of Change From Baseline to End of Study in ADHD-RS-IV Total Score (ITT Population).

ADHD-RS-IV scores	Placebo (N = 24)	SPN-812 (mg/day)
		100 (N = 45)	200 (N = 46)	300 (N = 47)	400 (N = 44)
Primary analysis
LS meana	−10.5	−16.7	−18.4	−18.6	−19.0
Placebo-adjusted treatment effectb	—	−6.2	−7.9	−8.1	−8.5
Effect size	—	0.453	0.547	0.596	0.623
p valueb,c	—	.0899	.0310d	.0268d	.0209d
Hyperactivity/Impulsivity Subscale
LS meana	−4.7	−7.9	−9.0	−9.5	−9.8
Placebo-adjusted treatment effectb	—	−3.1	−4.3	−4.8	−5.1
p valueb,c	—	.1007	.0254d	.0121d	.0086d
Inattention Subscale
LS meana	−5.7	−8.9	−9.0	−9.4	−9.5
Placebo-adjusted treatment effectb	—	−3.2	−3.2	−3.7	−3.7
p valueb,c	—	.1014	.0909	.0552	.0533
Sensitivity analysis using MMRM
LS meane	−10.7	−16.2	−17.3	−18.6	−19.5
Placebo-adjusted treatment effectb	—	−5.5	−6.6	−7.9	−8.8
p valueb,e	—	.0961	.0473	.0167	.0092

Note. ADHD-RS-IV = ADHD Rating Scale-IV; ITT = intention-to-treat; LS = least squares; MMRM = mixed model for repeated measures; ANOVA = analysis of variance.

^aEstimated from ANOVA including fixed effect for treatment.

^bLS mean of SPN-812 dose group minus LS mean of placebo group.

^cRaw (unadjusted for multiplicity) p values.

p < .05 versus placebo, estimated by ANOVA^d and MMRM^e.