Mean NPI-X Total Score from Week 4 through Week 24 - Windowed
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)	9.5 (12.10)	8.7 (9.82)	11.9 (13.70)	
Median (Range)	5.0 (0;66)	4.0 (0;32)	8.0 (0;61)	
Mean of Weeks 4-24				
n	78	75	69	
Mean (SD)	9.3 (11.18)	9.1 (12.10)	9.6 (11.60)	
Median (Range)	5.5 (0;65)	3.8 (0;51)	4.4 (0;46)	
Statistical comparison of the mean over Weeks 4 to 24				
p-value (dose response) [1][2]			0.637	
p-value (Xanomeline - Placebo) [1][3]		0.760	0.517	
Difference of LS means (SE)		0.3 (1.13)	-0.7 (1.15)	
95% CI		(-1.9;2.6)	(-3.0;1.5)	

Mean NPI-X Total Score from Week 4 through Week 24 - Windowed
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]			0.350	
Difference of LS means (SE)			-1.1 (1.17)	
95% CI			(-3.4;1.2)	
[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.
The Week 4 to Week 24 endpoint is the mean of a subject's available NPI-X (9) total scores over the Week 4 to Week 24 assessment windows, as the statistical analysis plan defines it in section 10.2.1. A subject contributes one value however many assessments it averages, and a subject with no assessment in that span contributes none, so n is smaller than the column N.
DEFINED HERE, NOT INHERITED: this endpoint is derived from the per-visit NPTOT records rather than read from the study's own NPTOTMN parameter, because the study's two authoritative statements about this table disagree. Its analysis results metadata (define.xml, Table14-3.12) selects PARAMCD NPTOTMN, which covers 210 of the 222 efficacy subjects who have an assessment in the Week 4 to Week 24 span: it omits 12 — eleven contributing a single assessment and one contributing two — and adds none. Selecting it reports n = 76, 69, 65. Its own reference report reports n = 78, 75, 69, which is every subject with an assessment in the span, and which the analysis plan's wording ('the mean of all available total scores between Weeks 4 and 24, inclusive') describes. The derivation used here follows the analysis plan and reproduces the reference report to every cell, including the ANCOVA. The divergence is measured and recorded in quality/data/efficacy-agreement.json.
Assessments are selected by AVISITN, not AVISIT: adqsnpix ships AVISIT right-aligned in a 16-character field, so a comparison against the visible label silently selects no records.
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 assessment date present in the vendored ADaM package.	
Source: adqsnpix (NPI-X (9) total score, PARAMCD NPTOT) 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 10.2.1. Reference report display: Table 14-3.12. Data cut-off: 2015-02-17. open.csr display t-eff-npix-mean (post-text variant); generated from the committed ARD.