ADAS-Cog (11) - Change from Baseline to Week 8 - LOCF
Study CDISCPILOT01 — Efficacy Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	
	(N=79)	(N=81)	(N=74)	
Baseline				
n	79	81	74	
Mean (SD)	24.1 (12.19)	24.4 (12.92)	21.3 (11.74)	
Median (Range)	21.0 (5;61)	21.0 (5;57)	18.0 (3;57)	
Week 8				
n	79	81	74	
Mean (SD)	25.0 (13.10)	26.2 (12.98)	22.3 (12.41)	
Median (Range)	22.0 (5;62)	25.0 (5;62)	19.0 (2;62)	
Change from baseline				
n	79	81	74	
Mean (SD)	0.8 (4.81)	1.8 (4.14)	1.0 (3.62)	
Median (Range)	1.0 (-12;16)	2.0 (-12;14)	1.0 (-8;13)	
Statistical comparison of the change from baseline				
p-value (dose response) [1][2]			0.497	
p-value (Xanomeline - Placebo) [1][3]		0.099	0.751	
Difference of LS means (SE)		1.1 (0.65)	0.2 (0.67)	
95% CI		(-0.2;2.4)	(-1.1;1.5)	

ADAS-Cog (11) - Change from Baseline to Week 8 - LOCF
Study CDISCPILOT01 — Efficacy Analysis Set
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	
	(N=79)	(N=81)	(N=74)	
p-value (Xanomeline High - Xanomeline Low) [1][3]			0.195	
Difference of LS means (SE)			-0.9 (0.66)	
95% CI			(-2.2;0.4)	
[1] Based on an analysis of covariance (ANCOVA) model with treatment and site group as factors and the baseline score as a covariate.
[2] Test for a non-zero coefficient for treatment (dose) as a continuous variable.
[3] Pairwise comparison with treatment as a categorical variable; p-values are not adjusted for multiple comparisons.
Missing post-baseline values are imputed by last observation carried forward, over assessments assigned to visit windows (CDISCPILOT01 statistical analysis plan, sections 8.1 and 8.2).
Treatment columns are planned treatment (TRTP), which is how the CDISCPILOT01 reference report presents them.
CDISCPILOT01 states no data cut-off date. The date shown is the latest ADAS-Cog assessment date present in the vendored ADaM package.	
Source: adqsadas (ADAS-Cog (11) total score, PARAMCD ACTOT) and adsl, from the CDISC pilot's own ADaM package (phuse-org/phuse-scripts, MIT). Analysis as specified in the CDISCPILOT01 statistical analysis plan, section 10.1.1. Reference report display: Table 14-3.03. Data cut-off: 2015-02-17. open.csr display t-eff-adas-wk8 (post-text variant); generated from the committed ARD.