Table 2. Effects of GV1001 on the total score of SIB and subscales in FAS and PPS.

Variable	Week	LS mean of CFB (± SE)
		FAS			PPS
		GV1001 1.12 mg (n=28)	Placebo (n=27)	p-value	GV1001 1.12 mg (n=25)	Placebo (n=26)	p-value
SIB, total	12	0.74±1.42	−3.65±1.45*	0.031	1.00±1.49	−4.04±1.47*	0.016
	24	−0.33±2.11	−6.93±2.09*	0.026	−0.12±2.13	−7.23±2.09*	0.017
Social interaction	12	−0.29±0.15	−0.25±0.16	0.865	−0.11±0.16	0.11±0.15	0.317
	24	−0.1±0.22	−0.42±0.22	0.314	0.05±0.18	0.18±0.18	0.603
Memory	12	0.55±0.47	−0.85±0.48*	0.037	0.55±0.51	−0.88±0.5*	0.047
	24	0.24±0.53	−0.70±0.53	0.210	0.23±0.54	−0.72±0.53	0.210
Orientation	12	−0.02±0.18	−0.35±0.18	0.199	−0.01±0,19	−0.33±0.19	0.245
	24	0.14±0.22	−0.42±0.21	0.067	0.15±0.22	−0.41±0.22	0.074
Language	12	0.37±0.74	−1.31±0.75	0.111	0.48±0.79	−1.53±0.77	0.069
	24	0.04±0.98	−3.26±0.97*	0.017	0.12±1.00	−3.42±0.98*	0.011
Attention	12	0.04±0.25	−0.2±0.25	0.503	0.09±0.26	−0.28±0.25	0.304
	24	−0.34±0.28	−0.26±0.28	0.823	−0.31±0.28	−0.32±0.28	0.976
Praxis	12	0.09±0.2	−0.38±0.20	0.101	0.09±0.21	−0.36±0.2	0.121
	24	−0.19±0.27	−0.95±0.27*	0.047	−0.19±0.27	−0.93±0.27	0.050
Visuospatial ability	12	−0.01±0.26	−0.17±0.27	0.672	−0.01±0.29	−0.14±0.29	0.757
	24	0.19±0.38	−0.77±0.38	0.074	0.19±0.39	−0.76±0.38	0.083
Construction	12	−0.02±0.17	−0.08±0.17	0.792	−0.03±0.19	−0.12±0.18	0.740
	24	−0.19±0.18	−0.1±0.17	0.735	−0.19±0.18	−0.12±0.18	0.770
Orientation to name	12	0.04±0.06	−0.08±0.06	0.140	0.04±0.06	−0.08±0.06	0.150
	24	−0.08±0.07	−0.08±0.07	0.964	−0.08±0.07	−0.08±0.07	0.959

p-value for the differences between the GV1001 and placebo groups. The differences between the treatment and placebo groups were assessed using the mixed-effects model for repeated measures analysis.

SIB: Severe Impairment Battery, FAS: full analysis set, PPS: per-protocol set, LS: least square, CFB: change from baseline, SE: standard error.

^*p<0.05.