SAS Output

Table x.y: Change from Baseline LDL-C by Scheduled Visit

Study CDISCPILOT01


	Placebo (N = 86)	Xanomeline Low Dose (N = 84)	Xanomeline High Dose (N = 84)
Week 2
Summary Statistics^a
n	84	78	78
Mean	-0.123	-0.097	-0.223
SE	0.059	0.056	0.060
Median	-0.129	-0.103	-0.181
Q1, Q3	-0.465, 0.065	-0.414, 0.259	-0.569, 0.181
Min, Max	-1.09, 3.05	-1.76, 1.14	-1.76, 0.80

LS Mean^b
Estimate (SE)	-0.123 (0.058)	-0.115 (0.059)	-0.218 (0.059)
95% CI	(-0.236, -0.009)	(-0.232, 0.002)	(-0.335, -0.101)

Treatment Difference (Active-Placebo)
Estimate (SE)	- (-)	0.008 (0.083)	-0.095 (0.083)
95% CI	(-, -)	(-0.155, 0.171)	(-0.258, 0.068)
Nominal p-value	-	0.9206	0.2535
N = number of subjects randomized; Xanomeline Low Dose = 54 mg; Xanomeline High Dose = 81 mg. ^aSummary statistics are based on observed data. ^bLS mean is from a repeated measures model which includes effects: treatment group, scheduled visit, and the interaction of treatment with scheduled visit.

Table x.y: Change from Baseline LDL-C by Scheduled Visit

Study CDISCPILOT01


	Placebo (N = 86)	Xanomeline Low Dose (N = 84)	Xanomeline High Dose (N = 84)
Week 4
Summary Statistics^a
n	82	70	72
Mean	-0.241	-0.206	-0.260
SE	0.063	0.059	0.060
Median	-0.233	-0.142	-0.284
Q1, Q3	-0.672, 0.052	-0.465, 0.103	-0.556, 0.078
Min, Max	-1.42, 2.25	-1.66, 0.91	-1.47, 1.11

LS Mean^b
Estimate (SE)	-0.239 (0.058)	-0.216 (0.062)	-0.269 (0.061)
95% CI	(-0.354, -0.124)	(-0.338, -0.094)	(-0.390, -0.148)

Treatment Difference (Active-Placebo)
Estimate (SE)	- (-)	0.023 (0.085)	-0.029 (0.085)
95% CI	(-, -)	(-0.145, 0.191)	(-0.196, 0.138)
Nominal p-value	-	0.7873	0.7298
N = number of subjects randomized; Xanomeline Low Dose = 54 mg; Xanomeline High Dose = 81 mg. ^aSummary statistics are based on observed data. ^bLS mean is from a repeated measures model which includes effects: treatment group, scheduled visit, and the interaction of treatment with scheduled visit.

Table x.y: Change from Baseline LDL-C by Scheduled Visit

Study CDISCPILOT01


	Placebo (N = 86)	Xanomeline Low Dose (N = 84)	Xanomeline High Dose (N = 84)
Week 6
Summary Statistics^a
n	75	62	67
Mean	-0.127	-0.205	-0.269
SE	0.078	0.070	0.078
Median	-0.129	-0.168	-0.362
Q1, Q3	-0.595, 0.259	-0.491, 0.078	-0.621, 0.259
Min, Max	-1.29, 3.10	-1.91, 1.22	-1.94, 1.06

LS Mean^b
Estimate (SE)	-0.139 (0.071)	-0.230 (0.076)	-0.292 (0.074)
95% CI	(-0.279, 0.000)	(-0.379, -0.081)	(-0.438, -0.147)

Treatment Difference (Active-Placebo)
Estimate (SE)	- (-)	-0.091 (0.104)	-0.153 (0.102)
95% CI	(-, -)	(-0.295, 0.113)	(-0.355, 0.049)
Nominal p-value	-	0.3807	0.1360
N = number of subjects randomized; Xanomeline Low Dose = 54 mg; Xanomeline High Dose = 81 mg. ^aSummary statistics are based on observed data. ^bLS mean is from a repeated measures model which includes effects: treatment group, scheduled visit, and the interaction of treatment with scheduled visit.

Table x.y: Change from Baseline LDL-C by Scheduled Visit

Study CDISCPILOT01


	Placebo (N = 86)	Xanomeline Low Dose (N = 84)	Xanomeline High Dose (N = 84)
Week 8
Summary Statistics^a
n	73	58	56
Mean	-0.238	-0.218	-0.271
SE	0.083	0.064	0.072
Median	-0.259	-0.246	-0.336
Q1, Q3	-0.621, 0.181	-0.543, 0.052	-0.556, 0.142
Min, Max	-2.87, 1.66	-1.58, 0.80	-2.61, 0.78

LS Mean^b
Estimate (SE)	-0.209 (0.072)	-0.245 (0.079)	-0.294 (0.079)
95% CI	(-0.350, -0.067)	(-0.400, -0.090)	(-0.450, -0.139)

Treatment Difference (Active-Placebo)
Estimate (SE)	- (-)	-0.037 (0.106)	-0.086 (0.107)
95% CI	(-, -)	(-0.247, 0.173)	(-0.296, 0.125)
Nominal p-value	-	0.7300	0.4227
N = number of subjects randomized; Xanomeline Low Dose = 54 mg; Xanomeline High Dose = 81 mg. ^aSummary statistics are based on observed data. ^bLS mean is from a repeated measures model which includes effects: treatment group, scheduled visit, and the interaction of treatment with scheduled visit.

Table x.y: Change from Baseline LDL-C by Scheduled Visit

Study CDISCPILOT01


	Placebo (N = 86)	Xanomeline Low Dose (N = 84)	Xanomeline High Dose (N = 84)
Week 12
Summary Statistics^a
n	67	50	50
Mean	-0.221	-0.315	-0.324
SE	0.070	0.067	0.090
Median	-0.155	-0.297	-0.349
Q1, Q3	-0.621, 0.207	-0.647, 0.000	-0.621, 0.155
Min, Max	-1.94, 1.03	-1.45, 0.88	-2.97, 0.65

LS Mean^b
Estimate (SE)	-0.212 (0.068)	-0.366 (0.076)	-0.344 (0.076)
95% CI	(-0.347, -0.077)	(-0.515, -0.216)	(-0.493, -0.195)

Treatment Difference (Active-Placebo)
Estimate (SE)	- (-)	-0.154 (0.102)	-0.132 (0.102)
95% CI	(-, -)	(-0.355, 0.048)	(-0.333, 0.069)
Nominal p-value	-	0.1338	0.1974
N = number of subjects randomized; Xanomeline Low Dose = 54 mg; Xanomeline High Dose = 81 mg. ^aSummary statistics are based on observed data. ^bLS mean is from a repeated measures model which includes effects: treatment group, scheduled visit, and the interaction of treatment with scheduled visit.

Table x.y: Change from Baseline LDL-C by Scheduled Visit

Study CDISCPILOT01


	Placebo (N = 86)	Xanomeline Low Dose (N = 84)	Xanomeline High Dose (N = 84)
Week 16
Summary Statistics^a
n	68	40	37
Mean	-0.114	-0.267	-0.238
SE	0.071	0.076	0.090
Median	-0.181	-0.233	-0.284
Q1, Q3	-0.465, 0.259	-0.608, 0.013	-0.543, 0.000
Min, Max	-1.50, 1.11	-1.27, 1.14	-1.34, 0.98

LS Mean^b
Estimate (SE)	-0.095 (0.067)	-0.306 (0.081)	-0.322 (0.083)
95% CI	(-0.227, 0.037)	(-0.467, -0.146)	(-0.486, -0.158)

Treatment Difference (Active-Placebo)
Estimate (SE)	- (-)	-0.211 (0.105)	-0.227 (0.107)
95% CI	(-, -)	(-0.419, -0.003)	(-0.438, -0.017)
Nominal p-value	-	0.0463	0.0347
N = number of subjects randomized; Xanomeline Low Dose = 54 mg; Xanomeline High Dose = 81 mg. ^aSummary statistics are based on observed data. ^bLS mean is from a repeated measures model which includes effects: treatment group, scheduled visit, and the interaction of treatment with scheduled visit.

Table x.y: Change from Baseline LDL-C by Scheduled Visit

Study CDISCPILOT01


	Placebo (N = 86)	Xanomeline Low Dose (N = 84)	Xanomeline High Dose (N = 84)
Week 20
Summary Statistics^a
n	66	30	31
Mean	-0.248	-0.412	-0.279
SE	0.083	0.083	0.087
Median	-0.310	-0.323	-0.336
Q1, Q3	-0.672, 0.207	-0.802, -0.078	-0.621, 0.129
Min, Max	-1.81, 1.40	-1.27, 0.31	-1.60, 0.80

LS Mean^b
Estimate (SE)	-0.219 (0.073)	-0.455 (0.095)	-0.401 (0.094)
95% CI	(-0.363, -0.075)	(-0.642, -0.268)	(-0.586, -0.217)

Treatment Difference (Active-Placebo)
Estimate (SE)	- (-)	-0.235 (0.119)	-0.182 (0.118)
95% CI	(-, -)	(-0.471, 0.001)	(-0.416, 0.052)
Nominal p-value	-	0.0506	0.1264
N = number of subjects randomized; Xanomeline Low Dose = 54 mg; Xanomeline High Dose = 81 mg. ^aSummary statistics are based on observed data. ^bLS mean is from a repeated measures model which includes effects: treatment group, scheduled visit, and the interaction of treatment with scheduled visit.

Table x.y: Change from Baseline LDL-C by Scheduled Visit

Study CDISCPILOT01


	Placebo (N = 86)	Xanomeline Low Dose (N = 84)	Xanomeline High Dose (N = 84)
Week 24
Summary Statistics^a
n	57	26	30
Mean	-0.343	-0.215	-0.259
SE	0.090	0.127	0.092
Median	-0.233	-0.103	-0.310
Q1, Q3	-0.750, 0.181	-0.569, 0.155	-0.569, 0.181
Min, Max	-2.30, 1.16	-1.81, 1.50	-1.60, 0.75

LS Mean^b
Estimate (SE)	-0.323 (0.080)	-0.224 (0.110)	-0.362 (0.104)
95% CI	(-0.482, -0.163)	(-0.440, -0.007)	(-0.568, -0.156)

Treatment Difference (Active-Placebo)
Estimate (SE)	- (-)	0.099 (0.136)	-0.039 (0.132)
95% CI	(-, -)	(-0.170, 0.368)	(-0.300, 0.221)
Nominal p-value	-	0.4679	0.7656
N = number of subjects randomized; Xanomeline Low Dose = 54 mg; Xanomeline High Dose = 81 mg. ^aSummary statistics are based on observed data. ^bLS mean is from a repeated measures model which includes effects: treatment group, scheduled visit, and the interaction of treatment with scheduled visit.

Table x.y: Change from Baseline LDL-C by Scheduled Visit

Study CDISCPILOT01


	Placebo (N = 86)	Xanomeline Low Dose (N = 84)	Xanomeline High Dose (N = 84)
Week 26
Summary Statistics^a
n	57	24	27
Mean	-0.275	-0.394	-0.180
SE	0.082	0.131	0.155
Median	-0.233	-0.349	-0.233
Q1, Q3	-0.776, 0.181	-0.905, -0.091	-0.672, 0.155
Min, Max	-1.63, 0.98	-1.34, 1.01	-2.33, 1.45

LS Mean^b
Estimate (SE)	-0.257 (0.084)	-0.359 (0.116)	-0.286 (0.111)
95% CI	(-0.424, -0.090)	(-0.589, -0.130)	(-0.505, -0.067)

Treatment Difference (Active-Placebo)
Estimate (SE)	- (-)	-0.102 (0.144)	-0.029 (0.139)
95% CI	(-, -)	(-0.386, 0.181)	(-0.304, 0.247)
Nominal p-value	-	0.4768	0.8368
N = number of subjects randomized; Xanomeline Low Dose = 54 mg; Xanomeline High Dose = 81 mg. ^aSummary statistics are based on observed data. ^bLS mean is from a repeated measures model which includes effects: treatment group, scheduled visit, and the interaction of treatment with scheduled visit.