. 2021 Jul 3;32(1):63–74. doi: 10.1007/s00787-021-01837-z

Table 2.

Primary efficacy analysis

Follow-up	Variable	Active (n = 72)	Control (n = 36)	p-value	Difference between groups Mean (95% CI)	Effect size
10 weeks	CGI-I global improvement	2.61 (0.83) 2 (1; 6) n = 72	3.83 (0.81) 4 (2; 5) n = 36	< 0.0001	− 1.22 (− 1.56; − 0.88)	1.48
Non-responders (CGI-I 3–4)	35 (48.6%)	34 (94.4%)		− 45.8 (− 61.7; − 30.0)
Responders (CGI-I 1–2)	37 (51.4%)	2 (5.6%)	< 0.0001	45.8 (30.0; 61.7)

Follow-up

Variable

Active (n = 72)

Control (n = 36)

p-value

Difference between groups Mean (95% CI)

Effect size

10 weeks

CGI-I global improvement

2.61 (0.83)

2 (1; 6)

n = 72

3.83 (0.81)

4 (2; 5)

n = 36

< 0.0001

− 1.22 (− 1.56; − 0.88)

1.48

Non-responders (CGI-I 3–4)

35 (48.6%)

34 (94.4%)

− 45.8 (− 61.7; − 30.0)

Responders (CGI-I 1–2)

37 (51.4%)

2 (5.6%)

< 0.0001

45.8 (30.0; 61.7)

Change from baseline to 10 weeks. PR-ESSENCE vs Controls (ITT population). Baseline values were carried forward to endpoint for dropouts

For categorical variables n (%) is presented. For continuous variables Mean (SD)/Median (Min; Max)/n = is presented for comparison between groups Fisher’s Exact test (lowest 1-sided p-value multiplied by 2) was used for dichotomous variables, and Fisher’s Non-Parametric Permutation Test was used for continuous variables. The confidence interval for dichotomous variables is the unconditional exact confidence limits. If no exact limits can be computed the asymptotic Wald confidence limits with continuity correction are calculated instead. The confidence interval for the mean difference between groups is based on Fishers non-parametric permutation test. Effect Size is Difference in Mean/Pooled SD