Table 4.

Change in AIMS, BARS and SAS scores over time

				groups
	Time pt.	(n = 20)	(n = 25)	p-value	Group	Time	Group*Time
AIMS	Baseline	0.9(0.3)	0.9(0.3)	0.99	F(5,42)=2.8	F(5,134)=1.6	F(5,134)=0.2
	1 month	0.5(0.3)	0.8(0.3)	0.48	P = NS	P = NS	P = NS
	3 months	0.1(0.4)†	0.4(0.3)	0.48
	6 months	0.04(0.4)†	0.4(0.3)	0.40
	9 months	0.2(0.4)	0.8(0.3)	0.26
	12 months	0.04(0.4)†	0.5(0.3)	0.37
BARS	Baseline	0.2(0.1)	0.4(0.1)	0.38	F(1,42)=0.2	F(5,136)=0.7	F(5,136)=0.7
	1 month	0.4(0.2)	0.1(0.1)	0.19	P = NS	P = NS	P = NS
	3 months	0.02(0.2)	0.3(0.2)	0.33
	6 months	0.03(0.2)	0.07(0.2)	0.89
	9 months	0.1(0.2)	0.3(0.2)	0.85
	12 months	0.1(0.2)	0.04(0.2)	0.81
SAS	Baseline	1.1(0.4)	1.0(0.3)	0.57	F(1,41)=3.3	F(5,131)=2.4	F(5,131)=2.5
	1 month	0.7(0.4)	0.8(0.4)	0.99	P = NS	P = 0.04	P = 0.04
	3 months	0.8(0.5)	1.2(0.4)	0.58
	6 months	0.7(0.5)	0.7(0.4)	0.92
	9 months	0.6(0.6)	3.2(0.4)****	0.0003
	12 months	1.6(0.5)	1.8(0.4)	0.75

All values are LS-mean (SE) unless otherwise specified.

We used a mixed model repeated measures (MMRM) approach with time (baseline, 1-, 3-, 6-, 9-, 12-month visits) as the within-subjects factor and treatment (RLAI+TAU vs. TAU alone) as the between-subjects factor. Analyses were adjusted for baseline dependent measure values. Reported p-values reflect between-group differences at the corresponding time point. Statistically significant within-group changes at each time point (relative to baseline values) are represented with asterisks:

^****p ≤ 0.0001

*** p ≤ 0.001

** p≤0.01

* p < 0.05

^†p < 0.08 (trend) for within group comparison for each time point against the baseline values.