Table 2.

Assessment of elevation of ALT by treatment during the study course at four (4 W), eight (8 W) and 13 weeks (13 W) in patients

Timeline	Pearson’s Chi-square	Likelihood ratio
(A) GR.2 Patients with elevated ALT at baseline
4-week	0.680 (p = 0.410)	0.685 (p = 0.408)
8-week	5.279 (p = 0.071)	5.351 (p = 0.069)
13-week	1.778 (p = 0.411)	1.826 (p = 0.401)
(B) GR.1 Patients with normal ALT at baseline
4-week	0.142 (p = 0.707)	0.142 (p = 0.706)
8-week	4.8 (p = 0.029)	5.221 (p = 0.022)
13-week	0.190 (p = 0.663)	0.189 (p = 0.664)

p-value that does not support relevance of the elevation is depicted in bold

A: Analysis was conducted in patients with baseline elevated ALT receiving different study treatment (active drug vs. placebo). Chi-square test was conducted between treatment and frequency of all patients with elevated or non-elevated ALT at each time-point

B: Analysis was conducted in patients with baseline normal ALT receiving a different study treatment (active drug vs. placebo). Chi-square test was conducted between treatment and frequency of all patients with elevated or non-elevated ALT at each time-point. Statistical significance was set at p ≤ 0.05

At 4-week and 13-week, likelihood of occurrence of ALT elevation did not reach any significant probability between the quetiapine and placebo sub-arms in either group (A [GR.2] vs. B [GR.1]). At 8-week, there was moderate probability of ALT elevation between the quetiapine and placebo sub-arms that was significant, however it was similar in both the groups (A [GR.2] vs. B [GR.1])