Summary of Populations (Summary)
Study CDISCPILOT01 — All Subjects
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	Total	
	(N=86)	(N=84)	(N=84)	(N=254)	
Intent-To-Treat (ITT)	86 (100%)	84 (100%)	84 (100%)	254 (100%)	
Safety	86 (100%)	84 (100%)	84 (100%)	254 (100%)	

Summary of Populations (Summary)
Study CDISCPILOT01 — All Subjects
	Placebo	Xanomeline Low Dose	Xanomeline High Dose	Total	
	(N=86)	(N=84)	(N=84)	(N=254)	
Efficacy	79 (92%)	81 (96%)	74 (88%)	234 (92%)	
Complete Week 24	60 (70%)	28 (33%)	30 (36%)	118 (46%)	
Complete Study	58 (67%)	25 (30%)	27 (32%)	110 (43%)	
N in the column headers is the number of subjects randomised to that treatment group; percentages are based on it. The reference report's note calls this the number of subjects "entered in study (i.e., signed informed consent)". This display does not repeat that wording: 306 subjects were screened and 254 randomised, and it is the 254 that N counts.
The ITT population includes all subjects randomised. The Safety population includes all randomised subjects known to have taken at least one dose of randomised study drug. The Efficacy population includes all subjects in the safety population who also have at least one post-baseline ADAS-Cog and CIBIC+ assessment.
Treatment groups are planned (randomised) treatment, TRT01P. In this ADSL planned and actual treatment agree for all 254 subjects.
The population line above reads All Subjects because that is what the reference report prints above this table. In this study it selects the same 254 subjects as the Intent-To-Treat row below, since the analysis dataset contains only randomised subjects and every one of them carries ITTFL = Y.
Complete Week 24 is the study's own COMP24FL. Complete Study is not a variable the study ships: the reference report prints the row but states no definition for it, so this display derives it as the complement of the study's own DISCONFL — a subject who did not discontinue. That derivation is open.csr's, not the study's, and the evidence for it is that it reproduces all four printed figures (58, 25, 27, 110) and the report's own narrative that 110 subjects completed the study through Week 26.
The cut-off shown is the latest subject end date (RFENDT) recorded in the vendored ADSL. The CDISC pilot package states no separate database-lock date.	
Source: adsl (phuse-org/phuse-scripts, data/adam/cdisc — the CDISC pilot submission's own ADaM package). Data cut-off: 2015-03-05. open.csr display t-populations (in-text variant); generated from the committed ARD.