14-6.01

Summary Statistics for Continuous Laboratory Values

Made 2026-10-17 from uploaded data.

CDISCPILOT01

Table 14-6.01

Summary Statistics for Continuous Laboratory Values

Safety Analysis Set

	Placebo			Xanomeline Low			Xanomeline High
	N	Mean (SD)	Change from Bsln Mean (SD)	N	Mean (SD)	Change from Bsln Mean (SD)	N	Mean (SD)	Change from Bsln Mean (SD)
Chemistry
Sodium (mmol/L)
Baseline	86	140.3 (2.74)	- (-)	82	140.0 (2.61)	- (-)	83	140.0 (3.11)	- (-)
Week 2	84	140.4 (2.62)	0.0 (3.35)	80	139.6 (2.47)	-0.3 (2.86)	77	139.1 (2.74)	-0.6 (2.87)
Week 4	82	139.9 (2.74)	-0.4 (3.58)	72	140.1 (2.40)	0.2 (3.16)	72	139.7 (2.75)	-0.3 (3.39)
Week 6	75	140.3 (2.58)	0.0 (3.08)	64	140.6 (2.69)	0.8 (3.25)	67	140.1 (2.61)	-0.2 (3.23)
Week 8	73	140.7 (2.48)	0.4 (3.33)	60	140.5 (2.58)	0.6 (3.33)	56	140.5 (3.15)	0.3 (3.79)
Week 12	67	140.4 (2.39)	0.2 (2.98)	52	141.1 (2.77)	1.1 (3.06)	49	140.2 (2.39)	-0.1 (2.79)
Week 16	68	141.1 (2.37)	0.9 (3.10)	42	141.0 (2.62)	1.2 (2.93)	37	141.6 (2.96)	1.4 (3.18)
Week 20	65	141.2 (2.53)	1.1 (3.01)	31	141.4 (2.53)	1.6 (3.42)	31	141.8 (3.87)	1.2 (3.61)
Week 24	57	141.7 (2.23)	1.6 (3.27)	27	141.5 (2.12)	1.2 (3.12)	30	141.6 (2.99)	1.0 (3.10)
Week 26	57	142.6 (2.25)	2.5 (2.90)	25	142.1 (2.08)	1.9 (3.13)	27	142.4 (3.07)	1.9 (3.43)
End of Treatment	84	141.5 (2.74)	1.1 (3.51)	82	141.1 (2.65)	1.3 (3.09)	80	140.5 (3.22)	0.5 (3.50)
Potassium (mmol/L)
Baseline	86	4.3 (0.43)	- (-)	81	4.3 (0.34)	- (-)	82	4.3 (0.41)	- (-)
Week 2	84	4.2 (0.41)	0.0 (0.37)	80	4.3 (0.41)	0.0 (0.38)	77	4.3 (0.40)	0.0 (0.46)
Week 4	82	4.2 (0.37)	-0.1 (0.38)	71	4.3 (0.40)	-0.1 (0.36)	72	4.2 (0.37)	-0.1 (0.46)
Week 6	75	4.3 (0.33)	0.0 (0.41)	64	4.3 (0.39)	-0.1 (0.41)	67	4.2 (0.32)	-0.1 (0.44)
Week 8	73	4.2 (0.37)	-0.1 (0.43)	60	4.3 (0.39)	0.0 (0.38)	56	4.2 (0.39)	0.0 (0.50)
Week 12	67	4.2 (0.41)	0.0 (0.46)	52	4.2 (0.42)	-0.2 (0.40)	49	4.2 (0.26)	-0.1 (0.39)
Week 16	68	4.2 (0.41)	0.0 (0.46)	42	4.3 (0.33)	-0.1 (0.35)	37	4.3 (0.27)	0.0 (0.35)
Week 20	64	4.3 (0.46)	0.0 (0.44)	31	4.3 (0.36)	0.0 (0.44)	31	4.3 (0.37)	0.0 (0.40)
Week 24	56	4.3 (0.44)	0.1 (0.44)	27	4.3 (0.41)	0.0 (0.35)	30	4.2 (0.42)	0.0 (0.50)
Week 26	57	4.2 (0.38)	0.0 (0.34)	25	4.3 (0.40)	0.0 (0.36)	27	4.3 (0.39)	0.0 (0.54)
End of Treatment	84	4.3 (0.43)	0.0 (0.41)	82	4.3 (0.43)	-0.1 (0.39)	80	4.2 (0.36)	-0.1 (0.47)
Chloride (mmol/L)
Baseline	86	105.7 (3.19)	- (-)	82	105.8 (3.25)	- (-)	83	105.4 (3.33)	- (-)
Week 2	84	106.0 (3.12)	0.3 (3.40)	80	105.6 (3.12)	0.0 (3.44)	77	104.4 (3.49)	-0.8 (3.88)
Week 4	82	105.6 (3.53)	-0.1 (4.24)	72	105.5 (2.88)	-0.3 (3.72)	72	105.0 (3.46)	-0.4 (3.94)
Week 6	75	105.5 (3.14)	-0.1 (3.61)	64	106.3 (3.07)	0.6 (3.78)	67	105.3 (3.09)	-0.3 (3.47)
Week 8	73	106.0 (3.34)	0.3 (3.52)	60	105.6 (3.01)	-0.2 (3.47)	56	105.2 (3.57)	-0.1 (3.71)
Week 12	67	105.3 (2.93)	-0.3 (3.75)	52	105.7 (3.21)	-0.4 (3.63)	49	105.2 (2.40)	-0.1 (2.64)
Week 16	68	105.5 (3.16)	0.0 (3.57)	42	106.2 (2.93)	0.2 (3.17)	37	105.9 (2.66)	0.6 (2.54)
Week 20	65	106.0 (3.68)	0.6 (4.13)	31	106.3 (2.75)	-0.1 (2.41)	31	105.4 (3.03)	-0.2 (3.69)
Week 24	57	105.5 (3.14)	-0.1 (3.82)	27	105.3 (2.52)	-1.2 (2.95)	30	105.3 (3.21)	-0.1 (3.06)
Week 26	57	106.2 (2.58)	0.8 (3.33)	25	105.7 (2.35)	-0.5 (2.72)	27	105.7 (3.44)	0.4 (2.92)
End of Treatment	84	105.6 (3.42)	-0.1 (3.86)	82	105.5 (3.37)	-0.1 (3.31)	80	105.0 (3.20)	-0.5 (3.17)
Bilirubin (umol/L)
Baseline	86	9.7 (3.96)	- (-)	82	9.4 (4.01)	- (-)	84	11.0 (5.35)	- (-)
Week 2	83	10.8 (12.26)	1.1 (10.29)	79	9.4 (4.16)	0.0 (3.08)	78	10.4 (3.94)	-0.6 (3.62)
Week 4	79	11.1 (13.57)	1.4 (11.65)	71	9.2 (3.84)	-0.3 (2.70)	72	10.9 (5.62)	-0.3 (3.07)
Week 6	73	9.6 (3.78)	0.1 (2.88)	62	9.5 (4.03)	0.0 (2.99)	66	10.9 (4.89)	-0.6 (3.18)
Week 8	72	9.4 (3.89)	-0.4 (3.43)	60	9.6 (4.72)	0.5 (3.11)	56	10.8 (5.21)	-0.7 (3.21)
Week 12	67	9.5 (3.56)	-0.1 (2.83)	51	8.8 (4.15)	0.1 (2.64)	50	11.5 (6.16)	-0.3 (4.78)
Week 16	68	10.0 (3.63)	0.2 (2.68)	42	8.8 (3.91)	0.4 (2.14)	37	11.6 (4.89)	-0.7 (4.28)
Week 20	65	10.1 (5.19)	0.3 (3.58)	30	8.8 (4.51)	0.3 (2.82)	31	11.8 (8.69)	-0.2 (6.41)
Week 24	55	9.4 (3.39)	0.1 (2.75)	25	10.1 (4.44)	1.1 (2.84)	30	12.3 (6.52)	-0.6 (2.89)
Week 26	57	10.0 (4.73)	0.4 (3.57)	25	10.2 (6.21)	1.4 (3.44)	27	12.2 (6.82)	-0.6 (5.31)
End of Treatment	82	11.2 (13.42)	1.4 (11.28)	80	9.8 (4.29)	0.5 (3.08)	80	11.1 (5.36)	0.0 (3.16)
Alkaline Phosphatase (U/L)
Baseline	86	77.7 (58.11)	- (-)	81	73.3 (20.72)	- (-)	83	71.0 (38.85)	- (-)
Week 2	84	77.7 (69.50)	0.1 (15.51)	80	73.0 (21.87)	0.3 (10.25)	78	72.2 (40.22)	-0.1 (8.09)
Week 4	82	78.0 (69.43)	0.4 (14.16)	72	73.2 (23.17)	-0.3 (11.12)	72	71.3 (40.65)	-0.7 (6.88)
Week 6	75	68.4 (21.53)	-0.4 (10.40)	64	72.7 (23.15)	-1.0 (10.83)	67	71.5 (43.40)	-0.2 (12.65)
Week 8	73	70.0 (27.15)	0.0 (10.67)	60	72.9 (23.84)	0.5 (14.09)	56	74.0 (45.60)	0.8 (13.54)
Week 12	67	72.1 (32.73)	1.8 (17.18)	52	69.5 (20.55)	-1.5 (9.41)	50	71.9 (46.65)	-1.7 (8.53)
Week 16	68	70.6 (29.49)	0.3 (16.98)	42	69.5 (19.43)	-1.7 (8.61)	37	74.7 (54.78)	-1.4 (8.29)
Week 20	65	72.6 (37.41)	1.9 (25.77)	31	70.6 (22.20)	-2.2 (9.90)	31	73.5 (55.23)	-2.7 (8.35)
Week 24	56	80.6 (68.06)	10.1 (58.71)	27	72.0 (21.80)	-0.4 (8.93)	30	64.4 (17.63)	-2.4 (7.44)
Week 26	57	81.0 (79.33)	10.1 (72.41)	25	68.6 (21.08)	-4.1 (10.74)	27	61.9 (16.60)	-3.9 (7.65)
End of Treatment	84	84.6 (84.86)	7.1 (49.37)	82	71.6 (23.80)	-1.1 (13.09)	80	70.3 (37.91)	-1.6 (12.00)
Gamma Glutamyl Transferase (U/L)
Baseline	86	24.9 (49.75)	- (-)	82	22.2 (15.57)	- (-)	84	22.8 (17.71)	- (-)
Week 2	84	24.2 (47.03)	-0.8 (5.52)	80	22.6 (15.52)	0.2 (9.48)	78	23.7 (18.17)	0.6 (8.96)
Week 4	82	24.5 (48.68)	-0.8 (5.69)	72	21.8 (13.82)	-1.1 (7.51)	72	23.3 (16.08)	0.1 (9.29)
Week 6	75	19.9 (15.55)	0.3 (6.11)	64	21.9 (13.72)	-0.6 (6.88)	67	21.6 (13.48)	-0.5 (6.74)
Week 8	73	20.6 (16.38)	0.1 (6.76)	60	23.6 (15.55)	1.1 (11.36)	56	26.8 (29.96)	4.0 (24.63)
Week 12	67	21.4 (15.04)	0.5 (5.70)	52	21.9 (13.97)	-0.7 (8.80)	50	24.7 (21.26)	1.2 (8.19)
Week 16	68	20.8 (13.00)	-0.1 (5.65)	42	22.8 (14.86)	-0.1 (6.38)	37	23.9 (17.79)	-1.3 (6.16)
Week 20	66	20.4 (13.90)	-0.5 (5.42)	31	24.1 (17.52)	-0.4 (5.90)	31	22.2 (11.28)	-0.5 (5.98)
Week 24	57	22.0 (16.68)	0.5 (10.90)	27	23.7 (14.75)	0.5 (7.28)	30	25.5 (22.64)	-0.9 (6.48)
Week 26	57	21.4 (13.91)	-0.4 (7.08)	25	22.0 (15.31)	-1.0 (8.44)	27	23.4 (18.73)	-3.4 (7.97)
End of Treatment	84	25.7 (48.78)	0.7 (9.60)	82	22.4 (14.03)	0.3 (10.36)	80	22.3 (15.66)	-0.6 (9.81)
Alanine Aminotransferase (U/L)
Baseline	86	17.6 (9.22)	- (-)	82	18.0 (8.72)	- (-)	84	19.2 (10.05)	- (-)
Week 2	83	18.0 (12.53)	0.2 (7.90)	80	20.9 (10.55)	2.8 (8.18)	78	21.0 (8.87)	1.6 (6.83)
Week 4	79	18.7 (12.91)	0.7 (8.66)	72	17.5 (7.66)	-0.7 (5.08)	72	21.3 (9.51)	2.1 (7.08)
Week 6	73	17.0 (9.92)	-0.3 (7.78)	62	17.0 (7.98)	-0.8 (4.87)	66	21.2 (9.49)	1.6 (6.11)
Week 8	72	16.7 (9.34)	-1.1 (5.05)	60	17.6 (7.86)	0.2 (5.45)	56	22.8 (17.49)	3.2 (17.24)
Week 12	67	18.0 (9.16)	0.0 (8.07)	51	18.5 (12.68)	0.1 (9.27)	50	21.0 (10.18)	0.7 (8.74)
Week 16	68	17.1 (7.39)	-0.8 (7.94)	42	17.3 (7.51)	0.7 (5.80)	37	19.6 (7.61)	-0.3 (7.58)
Week 20	65	16.1 (6.56)	-1.9 (7.49)	30	16.7 (6.33)	0.9 (4.77)	31	19.6 (6.82)	-0.3 (8.63)
Week 24	57	17.9 (15.61)	-0.3 (16.62)	26	18.2 (9.17)	1.6 (5.66)	30	21.0 (8.70)	0.2 (8.25)
Week 26	57	16.0 (5.98)	-2.1 (7.70)	25	17.8 (9.51)	1.5 (6.26)	27	18.9 (7.02)	-2.0 (7.01)
End of Treatment	84	18.1 (16.74)	0.4 (15.40)	82	18.3 (8.26)	0.3 (7.25)	80	19.5 (7.44)	0.1 (8.08)
Aspartate Aminotransferase (U/L)
Baseline	86	23.2 (7.50)	- (-)	82	23.4 (8.24)	- (-)	84	23.1 (6.61)	- (-)
Week 2	83	23.6 (12.35)	0.2 (8.96)	80	24.7 (8.06)	1.6 (6.53)	78	23.4 (5.20)	0.4 (5.63)
Week 4	79	23.9 (14.93)	0.5 (11.33)	72	22.3 (6.75)	-1.4 (6.40)	72	23.8 (5.85)	0.6 (5.75)
Week 6	73	22.0 (6.40)	-0.9 (6.38)	62	22.1 (6.11)	-0.4 (4.19)	66	24.1 (7.84)	0.4 (6.10)
Week 8	72	22.3 (7.05)	-1.1 (4.84)	60	22.7 (5.95)	0.3 (4.02)	56	25.7 (13.33)	1.6 (13.98)
Week 12	67	22.8 (7.64)	-0.6 (7.06)	51	24.2 (15.87)	1.5 (12.39)	50	23.3 (6.11)	-1.2 (6.26)
Week 16	68	22.8 (6.42)	-0.6 (6.43)	42	22.4 (10.34)	0.6 (7.62)	37	23.1 (5.78)	-0.7 (4.17)
Week 20	65	21.9 (5.90)	-1.6 (6.07)	30	20.7 (5.74)	0.4 (4.60)	31	24.0 (6.90)	-0.3 (6.18)
Week 24	57	25.2 (21.02)	1.2 (20.43)	26	22.4 (10.78)	2.1 (6.58)	30	24.4 (7.29)	-0.2 (5.48)
Week 26	57	21.5 (6.99)	-2.5 (7.29)	25	22.1 (11.85)	1.4 (7.69)	27	21.6 (5.71)	-3.1 (4.17)
End of Treatment	84	25.1 (21.33)	1.8 (19.03)	82	23.2 (8.21)	-0.3 (8.06)	80	22.7 (6.13)	-0.4 (6.36)
Blood Urea Nitrogen (mmol/L)
Baseline	86	5.5 (1.39)	- (-)	82	6.4 (1.97)	- (-)	84	5.8 (1.88)	- (-)
Week 2	84	5.8 (1.51)	0.3 (1.17)	80	6.6 (1.82)	0.3 (1.53)	78	6.0 (2.06)	0.3 (1.36)
Week 4	82	5.9 (1.47)	0.3 (1.11)	72	6.4 (1.63)	0.0 (1.37)	72	5.9 (1.87)	0.3 (1.30)
Week 6	75	6.1 (1.42)	0.5 (1.16)	64	6.4 (1.76)	-0.1 (1.32)	67	6.0 (2.06)	0.3 (1.43)
Week 8	73	5.6 (1.58)	0.0 (1.22)	60	6.3 (1.92)	0.0 (0.95)	56	5.9 (1.93)	0.1 (1.25)
Week 12	67	5.9 (1.61)	0.2 (1.24)	52	6.2 (1.49)	0.0 (1.45)	50	5.9 (1.76)	0.1 (1.50)
Week 16	68	5.8 (1.60)	0.2 (1.28)	42	6.0 (1.62)	-0.2 (1.25)	37	5.7 (1.92)	0.2 (1.29)
Week 20	66	5.8 (1.53)	0.1 (1.28)	31	5.6 (1.57)	-0.6 (1.39)	31	5.9 (2.25)	0.2 (1.50)
Week 24	57	5.9 (1.32)	0.3 (1.24)	27	6.0 (2.07)	0.0 (1.37)	30	5.3 (1.92)	-0.3 (1.37)
Week 26	57	6.1 (1.62)	0.4 (1.36)	25	5.7 (1.93)	-0.3 (1.14)	27	5.9 (2.47)	0.3 (1.40)
End of Treatment	84	5.9 (1.38)	0.3 (1.20)	82	6.6 (1.95)	0.2 (1.37)	80	5.7 (1.97)	0.0 (1.57)
Creatinine (umol/L)
Baseline	86	97.7 (17.78)	- (-)	82	103.5 (20.01)	- (-)	84	103.7 (19.37)	- (-)
Week 2	84	99.0 (17.51)	1.4 (8.06)	80	106.2 (21.26)	2.3 (10.51)	78	106.3 (21.18)	2.8 (9.50)
Week 4	82	98.6 (18.56)	1.1 (11.40)	72	105.1 (19.83)	2.0 (8.13)	72	105.8 (20.66)	2.6 (10.43)
Week 6	75	101.7 (18.46)	3.3 (12.14)	64	104.4 (19.85)	1.7 (9.31)	67	105.8 (20.87)	3.2 (9.94)
Week 8	73	99.1 (16.07)	0.0 (9.88)	60	104.3 (21.27)	1.8 (7.54)	56	106.1 (22.24)	3.2 (9.14)
Week 12	67	101.5 (16.53)	2.4 (9.68)	52	101.8 (17.72)	1.8 (7.99)	50	108.2 (20.48)	5.8 (10.95)
Week 16	68	100.4 (16.43)	1.2 (10.57)	42	98.5 (16.63)	-1.3 (9.29)	37	102.5 (17.86)	2.2 (9.18)
Week 20	66	100.3 (17.92)	1.3 (11.31)	31	97.2 (17.23)	-1.8 (8.17)	31	103.5 (19.66)	3.1 (11.76)
Week 24	57	99.3 (15.85)	0.8 (11.37)	27	99.2 (16.14)	1.7 (7.08)	30	100.2 (19.61)	-0.6 (10.36)
Week 26	57	100.0 (18.46)	2.0 (9.30)	25	99.7 (18.84)	2.9 (8.10)	27	101.8 (18.73)	0.3 (8.31)
End of Treatment	84	98.5 (16.13)	0.8 (10.77)	82	105.6 (19.79)	1.8 (8.60)	80	104.6 (20.50)	1.4 (10.38)
Urate (umol/L)
Baseline	86	285.0 (74.45)	- (-)	82	300.7 (77.78)	- (-)	84	302.2 (78.01)	- (-)
Week 2	84	284.0 (68.72)	-1.8 (50.16)	80	305.8 (74.25)	1.0 (40.56)	78	301.7 (81.96)	-2.7 (33.85)
Week 4	82	285.6 (69.22)	-0.6 (35.59)	72	299.5 (79.44)	-3.7 (38.80)	72	291.4 (79.28)	-9.5 (42.17)
Week 6	75	288.0 (68.73)	-1.1 (38.24)	64	298.1 (74.46)	-6.2 (30.89)	67	291.6 (74.82)	-9.8 (34.48)
Week 8	73	285.6 (65.63)	-5.1 (36.28)	60	290.9 (71.15)	-15.6 (30.49)	56	291.6 (76.76)	-11.2 (35.13)
Week 12	67	291.1 (70.07)	3.2 (40.20)	52	290.3 (63.20)	-11.5 (31.83)	50	294.2 (78.84)	-9.0 (36.29)
Week 16	68	285.8 (68.72)	-3.6 (41.33)	42	288.8 (58.78)	-12.9 (39.98)	37	284.1 (80.47)	-19.9 (36.13)
Week 20	66	301.9 (73.43)	12.1 (40.18)	31	279.7 (58.71)	-16.5 (44.34)	31	295.1 (85.89)	-9.6 (43.81)
Week 24	57	293.5 (73.47)	4.6 (42.98)	27	274.9 (57.72)	-19.2 (31.26)	30	288.5 (88.37)	-19.4 (50.03)
Week 26	57	291.9 (74.43)	5.1 (44.39)	25	279.3 (60.01)	-13.6 (39.12)	27	301.1 (86.31)	-12.6 (47.68)
End of Treatment	84	290.5 (73.86)	4.7 (46.43)	82	298.3 (80.54)	-3.1 (37.11)	80	292.4 (80.83)	-10.5 (42.35)
Phosphate (mmol/L)
Baseline	86	1.2 (0.15)	- (-)	81	1.2 (0.11)	- (-)	83	1.2 (0.15)	- (-)
Week 2	84	1.2 (0.15)	0.0 (0.16)	80	1.2 (0.15)	0.0 (0.16)	78	1.2 (0.18)	0.0 (0.19)
Week 4	82	1.1 (0.16)	0.0 (0.17)	71	1.1 (0.14)	0.0 (0.14)	72	1.2 (0.18)	0.0 (0.16)
Week 6	75	1.2 (0.15)	0.0 (0.17)	64	1.2 (0.17)	0.0 (0.17)	67	1.2 (0.15)	0.0 (0.16)
Week 8	73	1.1 (0.14)	0.0 (0.13)	60	1.1 (0.16)	0.0 (0.16)	56	1.2 (0.16)	0.0 (0.18)
Week 12	67	1.2 (0.16)	0.0 (0.18)	52	1.1 (0.14)	0.0 (0.18)	50	1.1 (0.15)	0.0 (0.17)
Week 16	68	1.1 (0.14)	0.0 (0.15)	42	1.1 (0.17)	0.0 (0.19)	37	1.2 (0.17)	0.0 (0.17)
Week 20	65	1.2 (0.17)	0.0 (0.15)	31	1.1 (0.13)	0.0 (0.14)	31	1.2 (0.15)	0.0 (0.16)
Week 24	56	1.2 (0.15)	0.0 (0.16)	27	1.2 (0.19)	0.1 (0.19)	30	1.1 (0.17)	0.0 (0.17)
Week 26	57	1.2 (0.15)	0.0 (0.18)	25	1.1 (0.17)	0.0 (0.17)	27	1.2 (0.19)	0.0 (0.20)
End of Treatment	84	1.2 (0.17)	0.0 (0.18)	82	1.2 (0.17)	0.0 (0.18)	80	1.2 (0.16)	0.0 (0.17)
Calcium (mmol/L)
Baseline	86	2.3 (0.09)	- (-)	82	2.3 (0.11)	- (-)	84	2.3 (0.10)	- (-)
Week 2	84	2.3 (0.09)	0.0 (0.10)	80	2.3 (0.12)	0.0 (0.10)	78	2.3 (0.11)	0.0 (0.11)
Week 4	82	2.3 (0.09)	0.0 (0.09)	72	2.3 (0.10)	0.0 (0.08)	72	2.3 (0.10)	0.0 (0.10)
Week 6	75	2.3 (0.09)	0.0 (0.10)	64	2.3 (0.10)	0.0 (0.08)	67	2.3 (0.09)	0.0 (0.10)
Week 8	73	2.3 (0.09)	0.0 (0.09)	60	2.3 (0.12)	0.0 (0.09)	56	2.3 (0.12)	0.0 (0.11)
Week 12	67	2.3 (0.09)	0.0 (0.08)	52	2.3 (0.10)	0.0 (0.07)	50	2.3 (0.09)	0.0 (0.09)
Week 16	68	2.3 (0.10)	0.0 (0.11)	42	2.3 (0.11)	0.0 (0.08)	37	2.3 (0.11)	0.0 (0.12)
Week 20	66	2.3 (0.09)	0.0 (0.09)	31	2.3 (0.10)	0.0 (0.09)	31	2.3 (0.08)	0.0 (0.09)
Week 24	57	2.3 (0.09)	-0.1 (0.10)	27	2.3 (0.11)	0.0 (0.12)	30	2.3 (0.10)	-0.1 (0.12)
Week 26	57	2.3 (0.10)	0.0 (0.10)	25	2.3 (0.10)	0.0 (0.08)	27	2.3 (0.09)	0.0 (0.10)
End of Treatment	84	2.3 (0.09)	0.0 (0.10)	82	2.3 (0.10)	0.0 (0.10)	80	2.3 (0.10)	0.0 (0.11)
Glucose (mmol/L)
Baseline	86	5.6 (2.14)	- (-)	82	5.4 (0.94)	- (-)	84	5.4 (1.34)	- (-)
Week 2	83	5.6 (1.87)	0.0 (1.37)	80	5.6 (1.75)	0.1 (1.50)	78	6.1 (2.92)	0.7 (2.06)
Week 4	79	5.6 (1.87)	0.0 (1.55)	70	5.4 (1.41)	-0.1 (1.09)	72	5.9 (1.84)	0.4 (1.25)
Week 6	73	5.7 (2.22)	0.1 (1.37)	62	5.3 (1.34)	-0.1 (1.12)	66	6.0 (2.80)	0.5 (2.20)
Week 8	72	5.5 (1.35)	-0.1 (2.09)	59	5.5 (1.76)	0.1 (1.34)	56	5.8 (2.15)	0.2 (1.68)
Week 12	67	6.1 (1.97)	0.4 (1.97)	51	5.9 (3.18)	0.4 (2.78)	49	6.0 (2.28)	0.4 (1.64)
Week 16	68	5.5 (1.42)	-0.2 (1.69)	42	5.3 (0.83)	-0.2 (0.89)	37	5.9 (2.30)	0.2 (1.74)
Week 20	65	5.8 (1.50)	0.1 (2.08)	30	5.7 (1.73)	0.1 (1.39)	31	5.8 (1.61)	0.2 (1.47)
Week 24	57	5.7 (1.83)	-0.1 (2.68)	26	5.7 (1.26)	0.2 (0.82)	30	6.0 (1.92)	0.5 (1.94)
Week 26	57	5.8 (1.85)	0.0 (1.60)	25	5.5 (1.72)	0.1 (1.35)	27	5.6 (1.01)	0.1 (1.66)
End of Treatment	84	5.6 (1.61)	0.0 (2.26)	82	5.4 (1.07)	-0.1 (1.03)	80	5.9 (2.15)	0.5 (1.62)
Protein (g/L)
Baseline	86	70.5 (4.72)	- (-)	82	70.4 (4.29)	- (-)	84	71.0 (4.24)	- (-)
Week 2	84	69.2 (4.93)	-1.3 (4.53)	80	69.5 (4.48)	-0.9 (3.63)	78	69.5 (4.31)	-1.6 (3.91)
Week 4	82	69.0 (4.18)	-1.6 (3.93)	72	68.8 (4.30)	-1.5 (3.97)	72	69.8 (4.54)	-1.4 (3.90)
Week 6	75	69.6 (3.95)	-1.2 (4.01)	64	68.8 (4.33)	-1.3 (4.17)	67	70.2 (4.28)	-1.1 (4.10)
Week 8	73	70.5 (5.20)	-0.4 (4.35)	60	69.2 (3.95)	-0.9 (3.71)	56	70.6 (3.78)	-1.0 (3.57)
Week 12	67	70.0 (4.28)	-0.6 (3.86)	52	69.3 (4.98)	-0.8 (3.62)	50	70.4 (3.83)	-1.0 (4.11)
Week 16	68	71.2 (4.57)	0.4 (4.39)	42	69.3 (4.79)	-0.5 (4.27)	37	70.5 (4.93)	-1.0 (4.57)
Week 20	66	70.0 (4.92)	-1.1 (4.53)	31	68.7 (4.82)	-1.3 (3.88)	31	69.5 (4.15)	-1.8 (4.13)
Week 24	57	70.1 (4.33)	-0.8 (4.81)	27	70.9 (6.11)	0.7 (4.03)	30	70.7 (3.47)	-0.7 (3.83)
Week 26	57	70.4 (4.48)	-0.5 (4.56)	25	69.4 (5.29)	-1.1 (4.26)	27	69.4 (4.89)	-2.5 (4.01)
End of Treatment	84	70.2 (4.26)	-0.3 (4.35)	82	70.1 (4.95)	-0.4 (3.97)	80	70.4 (3.91)	-0.7 (3.63)
Albumin (g/L)
Baseline	86	39.8 (2.81)	- (-)	82	39.8 (2.56)	- (-)	84	40.3 (2.84)	- (-)
Week 2	83	38.9 (3.11)	-1.0 (2.49)	80	38.7 (3.17)	-1.1 (2.71)	78	38.9 (2.76)	-1.4 (2.59)
Week 4	79	38.8 (3.29)	-1.0 (2.69)	72	38.6 (2.80)	-1.2 (2.66)	72	39.1 (3.05)	-1.3 (2.70)
Week 6	73	39.1 (2.56)	-1.0 (2.25)	62	38.4 (2.60)	-1.2 (2.49)	66	39.5 (2.76)	-1.0 (2.60)
Week 8	72	39.8 (3.51)	-0.4 (2.70)	60	39.1 (2.93)	-0.5 (2.73)	56	39.8 (2.33)	-0.9 (2.21)
Week 12	67	39.5 (3.49)	-0.5 (2.31)	51	38.9 (2.18)	-0.9 (2.19)	50	39.8 (2.45)	-0.6 (2.77)
Week 16	68	40.4 (3.02)	0.4 (2.45)	42	39.1 (2.98)	-0.4 (2.78)	37	39.9 (1.92)	-0.7 (2.76)
Week 20	65	39.6 (3.47)	-0.5 (2.86)	30	38.6 (2.66)	-1.2 (2.55)	31	39.6 (1.85)	-1.4 (2.86)
Week 24	57	39.7 (3.34)	-0.2 (2.88)	26	40.4 (2.52)	0.4 (2.40)	30	40.5 (2.10)	-0.5 (2.65)
Week 26	57	39.8 (3.02)	0.0 (2.26)	25	39.2 (2.39)	-1.0 (2.85)	27	40.0 (2.26)	-1.2 (2.78)
End of Treatment	84	39.6 (3.32)	-0.2 (2.69)	82	39.2 (2.97)	-0.5 (2.64)	80	39.8 (2.48)	-0.6 (2.64)
Cholesterol (mmol/L)
Baseline	86	5.8 (1.07)	- (-)	82	5.7 (1.00)	- (-)	84	5.8 (1.02)	- (-)
Week 2	84	5.6 (1.02)	-0.1 (0.54)	80	5.6 (0.92)	-0.1 (0.50)	78	5.6 (0.93)	-0.2 (0.53)
Week 4	82	5.5 (0.94)	-0.2 (0.57)	72	5.5 (0.97)	-0.2 (0.49)	72	5.5 (1.00)	-0.3 (0.51)
Week 6	75	5.6 (0.95)	-0.1 (0.67)	64	5.4 (0.95)	-0.2 (0.55)	67	5.5 (0.91)	-0.3 (0.64)
Week 8	73	5.5 (1.02)	-0.2 (0.71)	60	5.5 (0.96)	-0.2 (0.49)	56	5.5 (0.94)	-0.3 (0.54)
Week 12	67	5.5 (0.92)	-0.2 (0.57)	52	5.3 (0.90)	-0.3 (0.47)	50	5.4 (0.91)	-0.3 (0.63)
Week 16	68	5.6 (0.98)	-0.1 (0.58)	42	5.3 (1.00)	-0.3 (0.48)	37	5.4 (0.94)	-0.2 (0.55)
Week 20	66	5.5 (0.94)	-0.2 (0.68)	31	5.2 (0.86)	-0.4 (0.46)	31	5.3 (0.85)	-0.3 (0.49)
Week 24	57	5.5 (1.01)	-0.3 (0.68)	27	5.4 (0.94)	-0.2 (0.65)	30	5.3 (0.89)	-0.3 (0.50)
Week 26	57	5.5 (0.94)	-0.3 (0.62)	25	5.2 (0.76)	-0.4 (0.64)	27	5.4 (0.90)	-0.2 (0.81)
End of Treatment	84	5.5 (1.02)	-0.3 (0.76)	82	5.4 (0.96)	-0.3 (0.56)	80	5.4 (0.89)	-0.4 (0.60)
Creatine Kinase (U/L)
Baseline	86	86.9 (43.71)	- (-)	82	100.6 (68.87)	- (-)	84	104.0 (71.75)	- (-)
Week 2	83	90.3 (66.11)	2.4 (57.72)	80	106.1 (83.92)	6.0 (84.97)	78	93.8 (53.19)	-12.0 (52.92)
Week 4	79	96.9 (124.45)	8.3 (116.54)	72	93.2 (51.67)	-7.8 (55.54)	72	100.6 (58.39)	-4.8 (53.80)
Week 6	73	88.0 (42.36)	-0.3 (40.55)	62	89.0 (44.29)	-13.7 (59.25)	66	123.5 (227.36)	17.8 (187.17)
Week 8	72	93.8 (45.84)	1.2 (46.26)	60	90.0 (39.16)	-8.3 (61.09)	56	91.8 (52.25)	-9.3 (59.25)
Week 12	67	101.8 (78.66)	8.9 (67.77)	51	94.7 (53.59)	-7.2 (65.59)	50	96.6 (60.55)	-2.8 (66.47)
Week 16	68	104.9 (66.37)	12.7 (52.13)	42	97.5 (56.39)	-6.9 (72.02)	37	86.1 (47.70)	-1.6 (24.32)
Week 20	65	93.8 (46.56)	1.0 (42.07)	30	111.6 (137.04)	21.5 (136.75)	31	97.5 (68.57)	6.0 (28.57)
Week 24	57	127.4 (207.98)	32.6 (200.00)	26	83.6 (38.60)	0.8 (21.99)	30	90.9 (53.97)	-1.1 (23.40)
Week 26	57	94.1 (51.03)	2.0 (46.93)	25	69.9 (23.70)	-15.0 (17.45)	27	93.0 (59.94)	1.4 (43.90)
End of Treatment	84	112.6 (173.34)	24.6 (165.91)	82	98.2 (61.12)	-1.9 (67.09)	80	95.1 (56.32)	-9.9 (60.94)
Hematology
Hemoglobin (mmol/L)
Baseline	85	8.6 (0.83)	- (-)	82	8.6 (0.76)	- (-)	81	8.9 (0.78)	- (-)
Week 2	83	8.4 (0.76)	-0.2 (0.42)	80	8.4 (0.76)	-0.2 (0.46)	80	8.7 (0.83)	-0.2 (0.42)
Week 4	79	8.4 (0.82)	-0.2 (0.44)	71	8.4 (0.78)	-0.3 (0.50)	71	8.6 (0.78)	-0.2 (0.45)
Week 6	73	8.4 (0.77)	-0.2 (0.44)	62	8.3 (0.76)	-0.3 (0.46)	65	8.6 (0.75)	-0.3 (0.44)
Week 8	72	8.5 (0.76)	-0.2 (0.46)	59	8.3 (0.71)	-0.3 (0.39)	56	8.7 (0.73)	-0.3 (0.39)
Week 12	66	8.4 (0.83)	-0.2 (0.42)	50	8.3 (0.69)	-0.3 (0.34)	50	8.8 (0.79)	-0.3 (0.42)
Week 16	68	8.5 (0.73)	-0.1 (0.46)	42	8.3 (0.69)	-0.2 (0.42)	37	8.7 (0.70)	-0.3 (0.47)
Week 20	65	8.4 (0.80)	-0.2 (0.51)	30	8.2 (0.63)	-0.2 (0.46)	31	8.7 (0.79)	-0.4 (0.46)
Week 24	58	8.3 (0.82)	-0.2 (0.40)	25	8.4 (0.69)	-0.2 (0.36)	30	8.9 (0.85)	-0.3 (0.36)
Week 26	57	8.4 (0.80)	-0.2 (0.47)	25	8.3 (0.67)	-0.3 (0.39)	27	8.7 (0.74)	-0.5 (0.39)
End of Treatment	84	8.4 (0.78)	-0.2 (0.44)	82	8.4 (0.69)	-0.2 (0.44)	81	8.7 (0.79)	-0.2 (0.36)
Hematocrit
Baseline	85	0.4 (0.04)	- (-)	81	0.4 (0.04)	- (-)	80	0.4 (0.04)	- (-)
Week 2	83	0.4 (0.04)	0.0 (0.03)	80	0.4 (0.04)	0.0 (0.03)	80	0.4 (0.04)	0.0 (0.03)
Week 4	77	0.4 (0.04)	0.0 (0.03)	69	0.4 (0.04)	0.0 (0.03)	70	0.4 (0.04)	0.0 (0.03)
Week 6	72	0.4 (0.04)	0.0 (0.03)	60	0.4 (0.04)	0.0 (0.03)	65	0.4 (0.04)	0.0 (0.03)
Week 8	71	0.4 (0.04)	0.0 (0.03)	56	0.4 (0.03)	0.0 (0.02)	56	0.4 (0.03)	0.0 (0.03)
Week 12	65	0.4 (0.04)	0.0 (0.03)	49	0.4 (0.03)	0.0 (0.02)	50	0.4 (0.04)	0.0 (0.03)
Week 16	68	0.4 (0.04)	0.0 (0.03)	42	0.4 (0.03)	0.0 (0.03)	37	0.4 (0.03)	0.0 (0.04)
Week 20	64	0.4 (0.04)	0.0 (0.03)	30	0.4 (0.03)	0.0 (0.02)	31	0.4 (0.04)	0.0 (0.04)
Week 24	58	0.4 (0.04)	0.0 (0.03)	25	0.4 (0.04)	0.0 (0.02)	30	0.4 (0.04)	0.0 (0.04)
Week 26	56	0.4 (0.04)	0.0 (0.03)	25	0.4 (0.04)	0.0 (0.03)	27	0.4 (0.04)	0.0 (0.03)
End of Treatment	83	0.4 (0.04)	0.0 (0.03)	82	0.4 (0.04)	0.0 (0.03)	81	0.4 (0.04)	0.0 (0.03)
Ery. Mean Corpuscular Volume (fL)
Baseline	85	92.9 (5.69)	- (-)	81	94.6 (4.87)	- (-)	80	93.3 (5.91)	- (-)
Week 2	83	94.1 (5.31)	1.2 (3.93)	80	94.6 (4.12)	0.2 (3.57)	80	93.4 (5.93)	0.2 (3.91)
Week 4	77	94.6 (5.87)	1.7 (3.47)	69	95.1 (4.22)	0.6 (3.69)	70	93.0 (5.52)	0.0 (3.69)
Week 6	72	94.2 (6.21)	1.3 (3.79)	60	95.2 (4.51)	0.7 (3.68)	65	94.0 (6.61)	0.6 (3.99)
Week 8	71	94.3 (5.51)	1.5 (3.27)	56	94.9 (3.97)	0.6 (3.35)	56	94.4 (4.77)	0.4 (4.03)
Week 12	65	94.2 (5.66)	1.6 (3.81)	49	95.1 (4.17)	0.9 (3.91)	50	94.9 (4.90)	0.8 (4.20)
Week 16	68	94.1 (6.01)	1.7 (4.07)	42	95.8 (5.17)	1.2 (4.18)	37	94.7 (6.27)	0.6 (5.05)
Week 20	64	93.3 (5.58)	1.3 (4.14)	30	95.4 (5.43)	2.0 (3.29)	31	95.1 (5.91)	0.9 (5.12)
Week 24	58	93.9 (5.90)	1.6 (3.85)	25	94.3 (3.85)	0.8 (3.94)	30	95.0 (5.99)	0.7 (4.97)
Week 26	56	93.9 (6.40)	1.7 (4.48)	25	95.8 (4.33)	2.6 (3.70)	27	95.4 (6.19)	1.2 (3.93)
End of Treatment	83	94.4 (5.93)	1.4 (4.07)	82	95.0 (3.98)	0.6 (3.83)	81	93.8 (6.14)	0.7 (4.40)
Ery. Mean Corpuscular Hemoglobin (fmol(Fe))
Baseline	85	1.9 (0.12)	- (-)	82	1.9 (0.09)	- (-)	81	1.9 (0.13)	- (-)
Week 2	83	1.9 (0.11)	0.0 (0.07)	80	1.9 (0.09)	0.0 (0.07)	80	1.9 (0.13)	0.0 (0.07)
Week 4	79	1.9 (0.12)	0.0 (0.07)	71	1.9 (0.09)	0.0 (0.07)	71	1.9 (0.13)	0.0 (0.06)
Week 6	73	1.9 (0.13)	0.0 (0.08)	62	1.9 (0.08)	0.0 (0.05)	65	1.9 (0.13)	0.0 (0.08)
Week 8	72	1.9 (0.12)	0.0 (0.06)	59	1.9 (0.09)	0.0 (0.06)	56	1.9 (0.10)	0.0 (0.07)
Week 12	66	1.9 (0.12)	0.0 (0.06)	50	1.9 (0.09)	0.0 (0.05)	50	1.9 (0.09)	0.0 (0.07)
Week 16	68	1.9 (0.12)	0.0 (0.05)	42	1.9 (0.10)	0.0 (0.07)	37	1.9 (0.11)	0.0 (0.08)
Week 20	65	1.9 (0.11)	0.0 (0.06)	30	1.9 (0.08)	0.0 (0.06)	31	1.9 (0.12)	0.0 (0.08)
Week 24	58	1.9 (0.12)	0.0 (0.06)	25	1.9 (0.09)	0.0 (0.06)	30	1.9 (0.13)	0.0 (0.09)
Week 26	57	1.9 (0.12)	0.0 (0.07)	25	1.9 (0.08)	0.0 (0.08)	27	1.9 (0.12)	0.0 (0.08)
End of Treatment	84	1.9 (0.12)	0.0 (0.07)	82	1.9 (0.09)	0.0 (0.06)	81	1.9 (0.13)	0.0 (0.07)
Ery. Mean Corpuscular HGB Concentration (mmol/L)
Baseline	85	20.6 (0.87)	- (-)	81	20.2 (0.97)	- (-)	80	20.5 (0.87)	- (-)
Week 2	83	20.3 (0.77)	-0.3 (1.00)	80	20.3 (0.85)	0.0 (1.04)	80	20.4 (0.74)	0.0 (0.98)
Week 4	77	20.2 (0.78)	-0.4 (1.01)	69	20.2 (0.72)	0.0 (0.94)	70	20.5 (0.71)	-0.1 (0.90)
Week 6	72	20.5 (0.77)	-0.2 (0.98)	60	20.1 (0.84)	-0.2 (0.99)	65	20.4 (0.89)	-0.2 (1.00)
Week 8	71	20.3 (0.68)	-0.2 (0.85)	56	20.2 (0.83)	0.0 (0.92)	56	20.5 (0.76)	-0.1 (0.93)
Week 12	65	20.3 (0.74)	-0.3 (0.96)	49	20.3 (0.68)	0.0 (0.99)	50	20.5 (0.76)	-0.1 (1.03)
Week 16	68	20.2 (0.75)	-0.4 (1.02)	42	20.0 (0.82)	-0.2 (1.02)	37	20.4 (0.83)	-0.2 (1.11)
Week 20	64	20.3 (0.80)	-0.3 (0.94)	30	20.0 (0.85)	-0.4 (0.91)	31	20.3 (0.88)	-0.3 (1.22)
Week 24	58	20.1 (0.89)	-0.5 (1.01)	25	20.3 (0.91)	-0.3 (0.95)	30	20.4 (0.85)	-0.3 (1.29)
Week 26	56	20.3 (0.99)	-0.4 (1.16)	25	19.9 (0.94)	-0.6 (1.09)	27	20.2 (0.92)	-0.6 (1.12)
End of Treatment	83	20.2 (0.85)	-0.4 (0.99)	82	20.2 (0.81)	0.0 (0.98)	81	20.4 (0.78)	-0.1 (1.08)
Leukocytes (GI/L)
Baseline	85	6.9 (1.76)	- (-)	82	6.6 (1.96)	- (-)	81	6.5 (1.54)	- (-)
Week 2	83	6.5 (1.55)	-0.4 (1.40)	80	6.9 (1.99)	0.2 (1.37)	80	6.5 (1.59)	-0.1 (1.18)
Week 4	79	6.4 (1.63)	-0.4 (1.17)	71	6.8 (2.12)	0.1 (1.53)	71	6.6 (1.42)	0.1 (1.21)
Week 6	73	6.5 (1.57)	-0.4 (1.36)	62	6.9 (1.99)	0.1 (1.14)	65	7.0 (1.84)	0.4 (1.65)
Week 8	72	6.5 (1.70)	-0.3 (1.28)	59	7.1 (1.88)	0.3 (1.26)	56	6.9 (1.95)	0.4 (1.64)
Week 12	66	6.3 (1.28)	-0.5 (1.09)	50	6.8 (2.03)	0.2 (0.97)	50	6.6 (1.51)	0.0 (1.21)
Week 16	68	6.4 (1.50)	-0.5 (1.29)	42	6.6 (2.11)	0.2 (1.44)	37	6.8 (1.72)	-0.1 (1.37)
Week 20	65	6.5 (1.77)	-0.5 (1.40)	30	6.5 (1.94)	0.1 (1.24)	31	6.6 (1.67)	-0.2 (1.21)
Week 24	58	6.7 (1.77)	-0.2 (1.37)	25	6.3 (1.84)	0.0 (1.16)	30	6.7 (1.80)	-0.1 (1.16)
Week 26	57	6.4 (1.47)	-0.4 (1.24)	25	6.1 (1.93)	-0.3 (1.15)	27	6.7 (1.78)	-0.2 (1.42)
End of Treatment	84	6.6 (1.80)	-0.2 (1.32)	82	6.8 (2.17)	0.1 (1.35)	81	6.7 (1.76)	0.2 (1.37)
Lymphocytes (GI/L)
Baseline	85	1.8 (0.57)	- (-)	82	1.8 (0.57)	- (-)	81	1.7 (0.52)	- (-)
Week 2	83	1.7 (0.50)	-0.1 (0.37)	80	1.8 (0.66)	0.0 (0.45)	80	1.7 (0.50)	0.0 (0.38)
Week 4	79	1.7 (0.56)	0.0 (0.38)	71	1.8 (0.67)	0.0 (0.49)	71	1.7 (0.50)	0.0 (0.44)
Week 6	73	1.8 (0.58)	0.0 (0.41)	62	1.9 (0.64)	0.1 (0.47)	64	1.7 (0.48)	0.0 (0.44)
Week 8	72	1.8 (0.67)	0.0 (0.44)	59	1.9 (0.65)	0.1 (0.45)	56	1.7 (0.50)	0.0 (0.36)
Week 12	66	1.7 (0.58)	-0.1 (0.42)	50	1.8 (0.58)	-0.1 (0.45)	50	1.6 (0.47)	0.0 (0.37)
Week 16	68	1.7 (0.58)	-0.1 (0.42)	42	1.8 (0.63)	-0.1 (0.34)	37	1.7 (0.62)	0.0 (0.41)
Week 20	65	1.7 (0.50)	-0.1 (0.45)	30	1.7 (0.59)	-0.1 (0.50)	31	1.7 (0.59)	0.0 (0.36)
Week 24	58	1.8 (0.65)	0.0 (0.48)	25	1.8 (0.56)	-0.1 (0.37)	30	1.7 (0.56)	0.0 (0.37)
Week 26	57	1.8 (0.59)	0.0 (0.43)	25	1.7 (0.62)	-0.1 (0.39)	27	1.8 (0.61)	0.1 (0.50)
End of Treatment	84	1.8 (0.59)	0.0 (0.46)	82	1.8 (0.62)	0.0 (0.46)	81	1.6 (0.54)	0.0 (0.38)
Monocytes (GI/L)
Baseline	85	0.4 (0.15)	- (-)	82	0.5 (0.16)	- (-)	81	0.4 (0.12)	- (-)
Week 2	83	0.4 (0.15)	0.0 (0.14)	80	0.5 (0.16)	0.0 (0.13)	80	0.4 (0.15)	0.0 (0.12)
Week 4	79	0.4 (0.12)	0.0 (0.11)	71	0.5 (0.17)	0.0 (0.15)	71	0.4 (0.13)	0.0 (0.13)
Week 6	73	0.4 (0.15)	0.0 (0.13)	62	0.5 (0.19)	0.0 (0.16)	64	0.5 (0.15)	0.0 (0.13)
Week 8	72	0.4 (0.14)	0.0 (0.14)	59	0.5 (0.14)	0.0 (0.14)	56	0.5 (0.15)	0.0 (0.14)
Week 12	66	0.4 (0.13)	0.0 (0.13)	50	0.5 (0.15)	0.0 (0.12)	50	0.4 (0.15)	0.0 (0.11)
Week 16	68	0.5 (0.15)	0.0 (0.17)	42	0.5 (0.16)	0.0 (0.12)	37	0.5 (0.16)	0.0 (0.14)
Week 20	65	0.5 (0.16)	0.0 (0.15)	30	0.5 (0.13)	0.0 (0.13)	31	0.5 (0.17)	0.0 (0.18)
Week 24	58	0.5 (0.17)	0.0 (0.17)	25	0.5 (0.19)	0.0 (0.11)	30	0.5 (0.18)	0.0 (0.12)
Week 26	57	0.4 (0.14)	0.0 (0.14)	25	0.4 (0.17)	0.0 (0.12)	27	0.5 (0.14)	0.0 (0.13)
End of Treatment	84	0.5 (0.17)	0.0 (0.17)	82	0.5 (0.17)	0.0 (0.13)	81	0.5 (0.15)	0.0 (0.12)
Eosinophils (GI/L)
Baseline	85	0.1 (0.12)	- (-)	82	0.1 (0.12)	- (-)	81	0.1 (0.10)	- (-)
Week 2	83	0.1 (0.10)	0.0 (0.09)	80	0.2 (0.17)	0.0 (0.14)	80	0.1 (0.11)	0.0 (0.07)
Week 4	79	0.1 (0.13)	0.0 (0.09)	71	0.2 (0.14)	0.0 (0.11)	71	0.2 (0.15)	0.0 (0.13)
Week 6	73	0.1 (0.13)	0.0 (0.11)	62	0.2 (0.21)	0.1 (0.16)	64	0.2 (0.28)	0.1 (0.25)
Week 8	72	0.1 (0.10)	0.0 (0.10)	59	0.3 (0.26)	0.2 (0.23)	56	0.2 (0.25)	0.1 (0.19)
Week 12	66	0.1 (0.09)	0.0 (0.11)	50	0.3 (0.21)	0.1 (0.19)	50	0.2 (0.17)	0.1 (0.14)
Week 16	68	0.1 (0.08)	0.0 (0.10)	42	0.2 (0.16)	0.1 (0.13)	37	0.2 (0.21)	0.1 (0.17)
Week 20	65	0.1 (0.08)	0.0 (0.10)	30	0.2 (0.19)	0.1 (0.16)	31	0.1 (0.11)	0.0 (0.12)
Week 24	58	0.1 (0.08)	0.0 (0.09)	25	0.2 (0.14)	0.0 (0.12)	30	0.2 (0.15)	0.0 (0.13)
Week 26	57	0.1 (0.10)	0.0 (0.11)	25	0.2 (0.15)	0.0 (0.13)	27	0.1 (0.10)	0.0 (0.09)
End of Treatment	84	0.1 (0.08)	0.0 (0.10)	82	0.2 (0.17)	0.0 (0.14)	81	0.2 (0.20)	0.1 (0.18)
Basophils (GI/L)
Baseline	85	0.1 (0.04)	- (-)	82	0.1 (0.03)	- (-)	81	0.1 (0.02)	- (-)
Week 2	83	0.0 (0.02)	0.0 (0.03)	80	0.1 (0.03)	0.0 (0.03)	80	0.0 (0.03)	0.0 (0.02)
Week 4	79	0.0 (0.02)	0.0 (0.03)	71	0.0 (0.03)	0.0 (0.03)	71	0.0 (0.02)	0.0 (0.02)
Week 6	73	0.0 (0.03)	0.0 (0.03)	62	0.0 (0.03)	0.0 (0.03)	64	0.1 (0.03)	0.0 (0.03)
Week 8	72	0.0 (0.02)	0.0 (0.03)	59	0.1 (0.02)	0.0 (0.04)	56	0.1 (0.03)	0.0 (0.02)
Week 12	66	0.0 (0.02)	0.0 (0.04)	50	0.0 (0.02)	0.0 (0.03)	50	0.1 (0.03)	0.0 (0.02)
Week 16	68	0.0 (0.03)	0.0 (0.04)	42	0.0 (0.02)	0.0 (0.03)	37	0.1 (0.03)	0.0 (0.02)
Week 20	65	0.0 (0.03)	0.0 (0.03)	30	0.0 (0.02)	0.0 (0.03)	31	0.0 (0.02)	0.0 (0.03)
Week 24	58	0.0 (0.03)	0.0 (0.03)	25	0.0 (0.03)	0.0 (0.02)	30	0.1 (0.02)	0.0 (0.02)
Week 26	57	0.0 (0.02)	0.0 (0.03)	25	0.0 (0.03)	0.0 (0.02)	27	0.1 (0.03)	0.0 (0.03)
End of Treatment	84	0.0 (0.03)	0.0 (0.03)	82	0.0 (0.03)	0.0 (0.03)	81	0.1 (0.02)	0.0 (0.02)
Platelet (GI/L)
Baseline	84	250.3 (65.52)	- (-)	80	234.0 (58.25)	- (-)	81	227.7 (54.74)	- (-)
Week 2	83	246.2 (57.55)	-4.4 (36.21)	78	247.4 (59.37)	9.1 (46.36)	80	238.2 (59.77)	8.4 (31.55)
Week 4	78	243.8 (54.30)	-7.4 (40.04)	70	239.2 (57.80)	5.7 (39.75)	70	238.3 (49.60)	9.8 (29.21)
Week 6	73	250.8 (58.97)	-3.3 (36.82)	62	238.3 (55.74)	3.5 (43.39)	63	239.1 (56.79)	9.2 (37.82)
Week 8	72	246.0 (66.61)	-6.2 (42.35)	59	245.4 (60.21)	5.1 (46.18)	55	236.9 (70.88)	11.0 (48.13)
Week 12	65	241.9 (53.71)	-12.8 (42.62)	50	238.8 (49.49)	1.9 (24.69)	49	236.1 (53.03)	9.1 (34.47)
Week 16	68	241.8 (55.65)	-13.7 (43.45)	41	244.5 (57.60)	2.8 (32.93)	37	230.9 (58.00)	5.3 (25.87)
Week 20	65	248.4 (60.70)	-8.4 (30.42)	30	240.7 (64.07)	7.3 (42.65)	30	235.1 (65.46)	2.3 (22.80)
Week 24	57	238.8 (51.89)	-11.3 (35.06)	24	249.7 (63.44)	1.8 (33.48)	29	238.3 (67.53)	4.5 (26.74)
Week 26	56	247.6 (60.11)	-2.7 (41.73)	25	241.3 (57.16)	-1.9 (38.84)	27	237.4 (67.14)	0.3 (26.99)
End of Treatment	84	241.5 (59.49)	-8.5 (35.55)	82	236.7 (63.56)	1.1 (36.31)	81	233.8 (60.79)	4.1 (35.89)
Erythrocytes (TI/L)
Baseline	85	4.5 (0.45)	- (-)	82	4.5 (0.42)	- (-)	81	4.7 (0.47)	- (-)
Week 2	83	4.4 (0.40)	-0.1 (0.22)	80	4.4 (0.43)	-0.1 (0.27)	80	4.6 (0.47)	-0.1 (0.22)
Week 4	79	4.4 (0.45)	-0.1 (0.25)	71	4.4 (0.38)	-0.2 (0.30)	71	4.5 (0.49)	-0.1 (0.25)
Week 6	73	4.4 (0.37)	-0.1 (0.24)	62	4.3 (0.38)	-0.2 (0.27)	65	4.5 (0.50)	-0.1 (0.24)
Week 8	72	4.4 (0.41)	-0.1 (0.26)	59	4.4 (0.34)	-0.2 (0.24)	56	4.5 (0.45)	-0.1 (0.19)
Week 12	66	4.4 (0.44)	-0.1 (0.26)	50	4.3 (0.32)	-0.2 (0.20)	50	4.6 (0.47)	-0.1 (0.27)
Week 16	68	4.5 (0.41)	0.0 (0.27)	42	4.3 (0.36)	-0.1 (0.24)	37	4.6 (0.44)	-0.2 (0.26)
Week 20	65	4.5 (0.41)	-0.1 (0.30)	30	4.3 (0.32)	-0.1 (0.21)	31	4.5 (0.50)	-0.2 (0.30)
Week 24	58	4.4 (0.45)	-0.1 (0.23)	25	4.4 (0.38)	-0.1 (0.19)	30	4.6 (0.58)	-0.1 (0.24)
Week 26	57	4.4 (0.42)	0.0 (0.25)	25	4.4 (0.35)	-0.1 (0.20)	27	4.5 (0.47)	-0.2 (0.27)
End of Treatment	84	4.4 (0.43)	-0.1 (0.27)	82	4.4 (0.38)	-0.2 (0.25)	81	4.6 (0.49)	-0.1 (0.22)
Anisocytes
Baseline	7	1.0 (0.00)	- (-)	3	1.0 (0.00)	- (-)	7	1.0 (0.00)	- (-)
Week 2	6	1.0 (0.00)	0.0 (0.00)	9	1.0 (0.00)	0.0 (-)	5	1.0 (0.00)	0.0 (0.00)
Week 4	9	1.0 (0.00)	0.0 (0.00)	9	1.0 (0.00)	- (-)	4	1.0 (0.00)	0.0 (0.00)
Week 6	7	1.0 (0.00)	- (-)	5	1.0 (0.00)	- (-)	7	1.0 (0.00)	0.0 (0.00)
Week 8	7	1.0 (0.00)	0.0 (0.00)	2	1.0 (0.00)	- (-)	3	1.0 (0.00)	0.0 (0.00)
Week 12	9	1.0 (0.00)	0.0 (-)	3	1.0 (0.00)	- (-)	2	1.0 (0.00)	0.0 (-)
Week 16	4	1.0 (0.00)	0.0 (-)	9	1.0 (0.00)	- (-)	6	1.0 (0.00)	0.0 (0.00)
Week 20	5	1.0 (0.00)	0.0 (0.00)	2	1.0 (0.00)	- (-)	4	1.0 (0.00)	0.0 (-)
Week 24	3	1.0 (0.00)	- (-)	1	1.0 (-)	- (-)	3	1.0 (0.00)	0.0 (0.00)
Week 26	5	1.0 (0.00)	0.0 (0.00)	4	1.0 (0.00)	- (-)	4	1.0 (0.00)	0.0 (-)
End of Treatment	27	1.0 (0.00)	0.0 (0.00)	21	1.0 (0.00)	0.0 (-)	16	1.0 (0.00)	0.0 (0.00)
Macrocytes
Baseline	3	1.0 (0.00)	- (-)	4	1.0 (0.00)	- (-)	0	- (-)	- (-)
Week 2	5	1.0 (0.00)	- (-)	1	1.0 (-)	- (-)	2	1.0 (0.00)	- (-)
Week 4	5	1.0 (0.00)	- (-)	2	1.0 (0.00)	0.0 (0.00)	2	1.0 (0.00)	- (-)
Week 6	2	1.0 (0.00)	- (-)	4	1.0 (0.00)	0.0 (0.00)	3	1.0 (0.00)	- (-)
Week 8	3	1.0 (0.00)	- (-)	3	1.0 (0.00)	0.0 (-)	1	1.0 (-)	- (-)
Week 12	3	1.0 (0.00)	- (-)	1	1.0 (-)	0.0 (-)	4	1.0 (0.00)	- (-)
Week 16	6	1.0 (0.00)	0.0 (-)	2	1.0 (0.00)	0.0 (-)	5	1.0 (0.00)	- (-)
Week 20	3	1.0 (0.00)	- (-)	4	1.0 (0.00)	- (-)	6	1.0 (0.00)	- (-)
Week 24	6	1.0 (0.00)	- (-)	1	1.0 (-)	0.0 (-)	4	1.0 (0.00)	- (-)
Week 26	7	1.0 (0.00)	- (-)	3	1.0 (0.00)	0.0 (-)	4	1.0 (0.00)	- (-)
End of Treatment	21	1.0 (0.00)	0.0 (-)	13	1.0 (0.00)	0.0 (0.00)	14	1.0 (0.00)	- (-)
Microcytes
Week 2	0	- (-)	- (-)	0	- (-)	- (-)	1	1.0 (-)	- (-)
Week 6	0	- (-)	- (-)	0	- (-)	- (-)	1	1.0 (-)	- (-)
End of Treatment	0	- (-)	- (-)	0	- (-)	- (-)	1	1.0 (-)	- (-)
Poikilocytes
Week 2	1	1.0 (-)	- (-)	0	- (-)	- (-)	1	1.0 (-)	- (-)
End of Treatment	1	1.0 (-)	- (-)	0	- (-)	- (-)	1	1.0 (-)	- (-)
Polychromasia
Baseline	1	1.0 (-)	- (-)	1	1.0 (-)	- (-)	1	1.0 (-)	- (-)
Week 2	0	- (-)	- (-)	1	1.0 (-)	- (-)	2	1.0 (0.00)	0.0 (-)
Week 4	1	1.0 (-)	- (-)	2	1.0 (0.00)	- (-)	1	1.0 (-)	- (-)
Week 6	1	1.0 (-)	- (-)	1	1.0 (-)	- (-)	1	1.0 (-)	- (-)
Week 8	2	1.0 (0.00)	- (-)	0	- (-)	- (-)	1	1.0 (-)	- (-)
Week 12	2	1.0 (0.00)	- (-)	0	- (-)	- (-)	0	- (-)	- (-)
Week 16	0	- (-)	- (-)	2	1.0 (0.00)	- (-)	0	- (-)	- (-)
Week 20	1	1.0 (-)	0.0 (-)	1	1.0 (-)	- (-)	2	1.0 (0.00)	0.0 (-)
Week 24	1	1.0 (-)	0.0 (-)	0	- (-)	- (-)	1	1.0 (-)	- (-)
Week 26	2	1.0 (0.00)	0.0 (-)	0	- (-)	- (-)	0	- (-)	- (-)
End of Treatment	7	1.0 (0.00)	0.0 (-)	7	1.0 (0.00)	- (-)	5	1.0 (0.00)	0.0 (-)

[1] End of Treatment is the last on-treatment value.

Program: t-14-6-01.sas

Program `t-14-6-01.sas`

Version 1, written from Clinwright's patterns, 2026-10-17, checks passed.

/*==== 00-header ====*/
/*----------------------------------------------------------------------------
  Output  : Table 14-6.01 / Summary Statistics for Continuous Laboratory Values / Safety Analysis Set
  Program : t-14-6-01.sas   Reporting effort : CSR
  ADaM    : /work/adam (ADSL, ADADAS, ADCIBC, ADLBC, ADLBH, ADNPIX, ADTTE, ADVS, ADAE, ADCM, ADMH, ADEX)
  The header and the report step follow from the shell. The sections between
  them make WORK.FINAL, one record per row of the table, in order:
    _page     the page (1 unless the output is paged); _pagelbl its heading or empty
    _ord      the row's order; _indent the label's indentation (0 = flush left)
    _rowid    the uuid of the shell row it shows (WORK._SHELL); one shell row may
              have several (a category per value); a blank row's is blank-<n>
    _kind     label | stat | blank
    rowlabel  the row's label, as text
    col1      N
    col2      Mean (SD)
    col3      Change|from Bsln|Mean (SD)
    col4      N
    col5      Mean (SD)
    col6      Change|from Bsln|Mean (SD)
    col7      N
    col8      Mean (SD)
    col9      Change|from Bsln|Mean (SD)
  /work/_lib/clinwright.sas has %ls_bign, %ls_count, %ls_stats, %ls_npct, %ls_num.
----------------------------------------------------------------------------*/
libname adam "/work/adam" access=readonly;
%include "/work/_lib/clinwright.sas";
%ls_setup;

/* The shell's rows, in order, with each column's value pattern (_xx1-_xx9). */
data work._shell;
  length _page 8 _pagelbl $200 _ord 8 _indent 8 _rowid $36 _kind $5 _var $32 rowlabel $200 _xx1 $40 _xx2 $40 _xx3 $40 _xx4 $40 _xx5 $40 _xx6 $40 _xx7 $40 _xx8 $40 _xx9 $40;
  _page = 1; _pagelbl = '';
  _ord=1; _indent=0; _rowid='238924cd-1f8e-4827-ac53-7c9c9f6cdd82'; _kind='label'; _var=''; rowlabel='[Category]'; _xx1=''; _xx2=''; _xx3=''; _xx4=''; _xx5=''; _xx6=''; _xx7=''; _xx8=''; _xx9=''; output;
  _ord=2; _indent=1; _rowid='0369e377-e848-405f-a1b1-9b0824845896'; _kind='label'; _var=''; rowlabel='[Parameter]'; _xx1=''; _xx2=''; _xx3=''; _xx4=''; _xx5=''; _xx6=''; _xx7=''; _xx8=''; _xx9=''; output;
  _ord=3; _indent=2; _rowid='5b052799-944c-47c8-994e-0bba61adbc21'; _kind='stat'; _var=''; rowlabel='[Visit]'; _xx1='xx'; _xx2='xx.x (xx.xx)'; _xx3='xx.x (xx.xx)'; _xx4='xx'; _xx5='xx.x (xx.xx)'; _xx6='xx.x (xx.xx)'; _xx7='xx'; _xx8='xx.x (xx.xx)'; _xx9='xx.x (xx.xx)'; output;
run;

/*==== 10-data ====*/
/* Made from the output's analysis: the records of ADLBC with strip(AVISIT) ne '.' and index(PARAMCD, '_') = 0 of the subjects of ADSL with SAFFL = 'Y', by TRT01A. */
/* The population's subjects, in each column they count in. */
data work._popc;
  set adam.adsl(where=(saffl = 'Y'));
  if trt01a in ('Placebo') then do; _col = 1; output; end;
  if trt01a in ('Placebo') then do; _col = 2; output; end;
  if trt01a in ('Placebo') then do; _col = 3; output; end;
  if trt01a in ('Xanomeline Low Dose') then do; _col = 4; output; end;
  if trt01a in ('Xanomeline Low Dose') then do; _col = 5; output; end;
  if trt01a in ('Xanomeline Low Dose') then do; _col = 6; output; end;
  if trt01a in ('Xanomeline High Dose') then do; _col = 7; output; end;
  if trt01a in ('Xanomeline High Dose') then do; _col = 8; output; end;
  if trt01a in ('Xanomeline High Dose') then do; _col = 9; output; end;
  keep usubjid _col;
run;
data work._pop1; set adam.adsl(where=(saffl = 'Y')); keep usubjid trt01a; run;
proc sort data=work._pop1; by usubjid; run;
/* The records of ADLBC with strip(AVISIT) ne '.' and index(PARAMCD, '_') = 0, of the population's subjects, in each column. */
data work._stk; length usubjid $11 saffl $1 avisit $16 visit $17 param $48 paramcd $7 parcat1 $4; set adam.adlbc(keep=usubjid saffl avisit avisitn visit param paramcd paramn parcat1 aval chg) adam.adlbh(keep=usubjid saffl avisit avisitn visit param paramcd paramn parcat1 aval chg); run;
proc sort data=work._stk(where=(strip(AVISIT) ne '.' and index(PARAMCD, '_') = 0)) out=work._rec; by usubjid; run;
data work._an;
  merge work._rec(in=_r) work._pop1(in=_p);
  by usubjid;
  if _r and _p;
  if trt01a in ('Placebo') then do; _col = 1; output; end;
  if trt01a in ('Placebo') then do; _col = 2; output; end;
  if trt01a in ('Placebo') then do; _col = 3; output; end;
  if trt01a in ('Xanomeline Low Dose') then do; _col = 4; output; end;
  if trt01a in ('Xanomeline Low Dose') then do; _col = 5; output; end;
  if trt01a in ('Xanomeline Low Dose') then do; _col = 6; output; end;
  if trt01a in ('Xanomeline High Dose') then do; _col = 7; output; end;
  if trt01a in ('Xanomeline High Dose') then do; _col = 8; output; end;
  if trt01a in ('Xanomeline High Dose') then do; _col = 9; output; end;
run;
data work._cols; do _col = 1 to 9; output; end; run;
%ls_bign(data=work._popc, trt=_col, values=1|2|3|4|5|6|7|8|9, names=_lsn1 _lsn2 _lsn3 _lsn4 _lsn5 _lsn6 _lsn7 _lsn8 _lsn9);

/* Subjects and records per column. */
proc sort data=work._an(keep=usubjid _col) out=work._u; by _col usubjid; run;
data work._c;
  set work._u;
  by _col usubjid;
  retain _n _e;
  if first._col then do; _n = 0; _e = 0; end;
  _e = _e + 1;
  if first.usubjid then _n = _n + 1;
  if last._col then output;
  keep _col _n _e;
run;
proc transpose data=work._c out=work._tn(drop=_name_) prefix=_n; id _col; var _n; run;
proc transpose data=work._c out=work._te(drop=_name_) prefix=_e; id _col; var _e; run;
data work._z; _z = 1; run;
data work._g1;
  merge work._z work._tn work._te;
  array _nn{9} _n1-_n9;
  array _ee{9} _e1-_e9;
  do _i = 1 to 9; _nn{_i} = sum(_nn{_i}, 0); _ee{_i} = sum(_ee{_i}, 0); end;
  _tot = sum(of _n1-_n9);
  drop _i _z;
run;
/* Per value of parcat1: subjects and records per column. */
proc sort data=work._an(keep=usubjid _col parcat1 where=(not missing(parcat1))) out=work._u; by parcat1 _col usubjid; run;
data work._c;
  set work._u;
  by parcat1 _col usubjid;
  retain _n _e;
  if first._col then do; _n = 0; _e = 0; end;
  _e = _e + 1;
  if first.usubjid then _n = _n + 1;
  if last._col then output;
  keep parcat1 _col _n _e;
run;
proc transpose data=work._c out=work._tn(drop=_name_) prefix=_n; by parcat1; id _col; var _n; run;
proc transpose data=work._c out=work._te(drop=_name_) prefix=_e; by parcat1; id _col; var _e; run;
data work._g0;
  merge work._tn work._te; by parcat1;
  array _nn{9} _n1-_n9;
  array _ee{9} _e1-_e9;
  do _i = 1 to 9; _nn{_i} = sum(_nn{_i}, 0); _ee{_i} = sum(_ee{_i}, 0); end;
  _tot = sum(of _n1-_n9);
  drop _i;
run;
proc sort data=work._g0; by  parcat1; run;
data work._g0;
  set work._g0;
  _o1 = _n_;
run;
/* [Category] of PARCAT1. */
data work._f; set work._g0; do _col = 1 to 9; output; end; run;
proc sort data=work._f; by parcat1 _col; run;
data work._k1;
  length _rowid $36 _label _pagelbl $200 _v $200;
  set work._f;
  array _nn{9} _n1-_n9;
  array _ee{9} _e1-_e9;
  _rowid = '238924cd-1f8e-4827-ac53-7c9c9f6cdd82';
  _page = 1;
  _pagelbl = '';
  _k0 = 1;
  _k1 = _o1; _k2 = 0;
  _k3 = 0; _k4 = 0;
  _k5 = 0; _k6 = 0;
  _label = strip(parcat1);
  if parcat1 = 'CHEM' then _label = 'Chemistry';
  if parcat1 = 'HEM' then _label = 'Hematology';
  if parcat1 = 'HYLAW' then _label = 'Hy''s Law';
  _v = '';
  keep _rowid _label _page _pagelbl _k0 _k1 _k2 _k3 _k4 _k5 _k6 _col _v;
run;
/* Per value of parcat1 and param: subjects and records per column. */
proc sort data=work._an(keep=usubjid _col parcat1 param paramn where=(not missing(parcat1) and not missing(param))) out=work._u; by parcat1 param _col usubjid; run;
data work._c;
  set work._u;
  by parcat1 param _col usubjid;
  retain _n _e;
  if first._col then do; _n = 0; _e = 0; end;
  _e = _e + 1;
  if first.usubjid then _n = _n + 1;
  if last._col then output;
  keep parcat1 param paramn _col _n _e;
run;
proc transpose data=work._c out=work._tn(drop=_name_) prefix=_n; by parcat1 param paramn; id _col; var _n; run;
proc transpose data=work._c out=work._te(drop=_name_) prefix=_e; by parcat1 param paramn; id _col; var _e; run;
data work._g2;
  merge work._tn work._te; by parcat1 param paramn;
  array _nn{9} _n1-_n9;
  array _ee{9} _e1-_e9;
  do _i = 1 to 9; _nn{_i} = sum(_nn{_i}, 0); _ee{_i} = sum(_ee{_i}, 0); end;
  _tot = sum(of _n1-_n9);
  drop _i;
run;
proc sort data=work._g2; by parcat1 paramn param; run;
data work._g2;
  set work._g2;
  by parcat1;
  retain _r;
  if first.parcat1 then _r = 0;
  _r = _r + 1;
  _o2 = _r;
  drop _r;
run;
proc sort data=work._g2; by parcat1; run;
proc sort data=work._g0(keep=parcat1 _o1) out=work._gp; by parcat1; run;
data work._g2; merge work._g2(in=_in) work._gp; by parcat1; if _in; run;
/* [Parameter] of PARAM. */
data work._f; set work._g2; do _col = 1 to 9; output; end; run;
proc sort data=work._f; by parcat1 param _col; run;
data work._k2;
  length _rowid $36 _label _pagelbl $200 _v $200;
  set work._f;
  array _nn{9} _n1-_n9;
  array _ee{9} _e1-_e9;
  _rowid = '0369e377-e848-405f-a1b1-9b0824845896';
  _page = 1;
  _pagelbl = '';
  _k0 = 1;
  _k1 = _o1; _k2 = 2;
  _k3 = _o2; _k4 = 0;
  _k5 = 0; _k6 = 0;
  _label = strip(param);
  _v = '';
  keep _rowid _label _page _pagelbl _k0 _k1 _k2 _k3 _k4 _k5 _k6 _col _v;
run;
/* Per value of parcat1 and param and avisit: subjects and records per column. */
proc sort data=work._an(keep=usubjid _col parcat1 param avisit avisitn where=(not missing(parcat1) and not missing(param) and not missing(avisit))) out=work._u; by parcat1 param avisit _col usubjid; run;
data work._c;
  set work._u;
  by parcat1 param avisit _col usubjid;
  retain _n _e;
  if first._col then do; _n = 0; _e = 0; end;
  _e = _e + 1;
  if first.usubjid then _n = _n + 1;
  if last._col then output;
  keep parcat1 param avisit avisitn _col _n _e;
run;
proc transpose data=work._c out=work._tn(drop=_name_) prefix=_n; by parcat1 param avisit avisitn; id _col; var _n; run;
proc transpose data=work._c out=work._te(drop=_name_) prefix=_e; by parcat1 param avisit avisitn; id _col; var _e; run;
data work._g3;
  merge work._tn work._te; by parcat1 param avisit avisitn;
  array _nn{9} _n1-_n9;
  array _ee{9} _e1-_e9;
  do _i = 1 to 9; _nn{_i} = sum(_nn{_i}, 0); _ee{_i} = sum(_ee{_i}, 0); end;
  _tot = sum(of _n1-_n9);
  drop _i;
run;
proc sort data=work._g3; by parcat1 param avisitn avisit; run;
data work._g3;
  set work._g3;
  by parcat1 param;
  retain _r;
  if first.param then _r = 0;
  _r = _r + 1;
  _o3 = _r;
  drop _r;
run;
proc sort data=work._g3; by parcat1 param; run;
proc sort data=work._g2(keep=parcat1 param _o1 _o2) out=work._gp; by parcat1 param; run;
data work._g3; merge work._g3(in=_in) work._gp; by parcat1 param; if _in; run;
/* [Visit]: count of AVISIT. */
data work._f; set work._g3; do _col = 1 to 9; output; end; run;
proc sort data=work._f; by parcat1 param avisit _col; run;
%ls_stats(data=work._an, out=work._cs0, var=aval, trt=_col, by=parcat1 param avisit, keepraw=Y);
data work._cs0;
  set work._cs0(rename=(_vn=_c0n _vmean=_c0mean _vsd=_c0sd _vmedian=_c0median _vq1=_c0q1 _vq3=_c0q3 _vmin=_c0min _vmax=_c0max _vcv=_c0cv _vgmean=_c0gmean _vgcv=_c0gcv _vglo=_c0glo _vghi=_c0ghi));
  keep parcat1 param avisit _col _c0n _c0mean _c0sd _c0median _c0q1 _c0q3 _c0min _c0max _c0cv _c0gmean _c0gcv _c0glo _c0ghi;
run;
%ls_stats(data=work._an, out=work._cs1, var=chg, trt=_col, by=parcat1 param avisit, keepraw=Y);
data work._cs1;
  set work._cs1(rename=(_vn=_c1n _vmean=_c1mean _vsd=_c1sd _vmedian=_c1median _vq1=_c1q1 _vq3=_c1q3 _vmin=_c1min _vmax=_c1max _vcv=_c1cv _vgmean=_c1gmean _vgcv=_c1gcv _vglo=_c1glo _vghi=_c1ghi));
  keep parcat1 param avisit _col _c1n _c1mean _c1sd _c1median _c1q1 _c1q3 _c1min _c1max _c1cv _c1gmean _c1gcv _c1glo _c1ghi;
run;
data work._k3;
  length _rowid $36 _label _pagelbl $200 _v $200;
  merge work._f(in=_in) work._cs0 work._cs1;
  by parcat1 param avisit _col;
  if _in;
  array _nn{9} _n1-_n9;
  array _ee{9} _e1-_e9;
  _rowid = '5b052799-944c-47c8-994e-0bba61adbc21';
  _page = 1;
  _pagelbl = '';
  _k0 = 1;
  _k1 = _o1; _k2 = 2;
  _k3 = _o2; _k4 = 3;
  _k5 = _o3; _k6 = 0;
  _label = strip(avisit);
  if _col = 1 then _v = strip(ifc(missing(sum(_c0n, 0)), '-', %ls_num(sum(_c0n, 0), 0)));
  else if _col = 2 then _v = strip(ifc(missing(_c0mean), '-', %ls_num(_c0mean, 1))) || ' (' || strip(ifc(missing(_c0sd), '-', %ls_num(_c0sd, 2))) || ')';
  else if _col = 3 then _v = strip(ifc(missing(_c1mean), '-', %ls_num(_c1mean, 1))) || ' (' || strip(ifc(missing(_c1sd), '-', %ls_num(_c1sd, 2))) || ')';
  else if _col = 4 then _v = strip(ifc(missing(sum(_c0n, 0)), '-', %ls_num(sum(_c0n, 0), 0)));
  else if _col = 5 then _v = strip(ifc(missing(_c0mean), '-', %ls_num(_c0mean, 1))) || ' (' || strip(ifc(missing(_c0sd), '-', %ls_num(_c0sd, 2))) || ')';
  else if _col = 6 then _v = strip(ifc(missing(_c1mean), '-', %ls_num(_c1mean, 1))) || ' (' || strip(ifc(missing(_c1sd), '-', %ls_num(_c1sd, 2))) || ')';
  else if _col = 7 then _v = strip(ifc(missing(sum(_c0n, 0)), '-', %ls_num(sum(_c0n, 0), 0)));
  else if _col = 8 then _v = strip(ifc(missing(_c0mean), '-', %ls_num(_c0mean, 1))) || ' (' || strip(ifc(missing(_c0sd), '-', %ls_num(_c0sd, 2))) || ')';
  else if _col = 9 then _v = strip(ifc(missing(_c1mean), '-', %ls_num(_c1mean, 1))) || ' (' || strip(ifc(missing(_c1sd), '-', %ls_num(_c1sd, 2))) || ')';
  keep _rowid _label _page _pagelbl _k0 _k1 _k2 _k3 _k4 _k5 _k6 _col _v;
run;

data work._cells; set work._k1 work._k2 work._k3; run;
proc sort data=work._cells; by _page _pagelbl _k0 _k1 _k2 _k3 _k4 _k5 _k6 _rowid _label _col; run;
proc transpose data=work._cells out=work._wide(drop=_name_) prefix=col;
  by _page _pagelbl _k0 _k1 _k2 _k3 _k4 _k5 _k6 _rowid _label;
  id _col;
  var _v;
run;
proc sort data=work._wide; by _rowid; run;
proc sort data=work._shell(drop=_page _pagelbl) out=work._rows; by _rowid; run;
data work._inst;
  merge work._wide(in=_w) work._rows(in=_s);
  by _rowid;
  if _w and _s;
  if _label ne '' then rowlabel = _label;
run;
data work._fixed;
  set work._shell;
  if _rowid not in ('238924cd-1f8e-4827-ac53-7c9c9f6cdd82' '0369e377-e848-405f-a1b1-9b0824845896' '5b052799-944c-47c8-994e-0bba61adbc21');
  _k0 = _ord; _k1 = 0; _k2 = 0; _k3 = 0; _k4 = 0; _k5 = 0; _k6 = 0;
run;
data work.final;
  length col1 col2 col3 col4 col5 col6 col7 col8 col9 $200 _pagelbl $200;
  set work._inst work._fixed;
run;
proc sort data=work.final; by _page _k0 _k1 _k2 _k3 _k4 _k5 _k6; run;
data work.final;
  set work.final;
  _ord = _n_;
  keep _page _pagelbl _ord _indent _rowid _kind rowlabel col1 col2 col3 col4 col5 col6 col7 col8 col9;
run;

/*==== 90-report ====*/
/* 90-report: from the shell; the titles, columns, headers and footnotes are not changed here. */
%ls_final_check(columns=_page _pagelbl _ord _indent _rowid _kind rowlabel col1 col2 col3 col4 col5 col6 col7 col8 col9);
proc sort data=work.final out=work._report; by _page _ord; run;
data work._report;
  set work._report;
  /* Two spaces per step of indentation: the label column keeps leading spaces (asis=on). */
  if _indent > 0 then rowlabel = repeat(' ', 2 * _indent - 1) || rowlabel;
run;
%let _lspaged = 0;
proc sql noprint; select count(*) into :_lspaged trimmed from work._report where _pagelbl ne ''; quit;

options orientation=landscape;
ods listing close;
ods rtf file="/work/out/t-14-6-01.rtf" style=journal;
title1 j=l "CDISCPILOT01" j=r "Page ~{thispage} of ~{lastpage}";
title2 j=c "Table 14-6.01";
title3 j=c "Summary Statistics for Continuous Laboratory Values";
title4 j=c "Safety Analysis Set";
footnote1 j=l "[1] End of Treatment is the last on-treatment value.";
footnote2 j=l "Program: t-14-6-01.sas";
%macro _ls_report;
proc report data=work._report nowd split='|' missing style(report)={width=100%};
  column _page _pagelbl _ord _indent _kind rowlabel ("Placebo" col1 col2 col3) ("Xanomeline Low" col4 col5 col6) ("Xanomeline High" col7 col8 col9);
  define _page / order order=internal noprint;
  define _pagelbl / order noprint;
  define _ord / order order=internal noprint;
  define _indent / display noprint;
  define _kind / display noprint;
  define rowlabel / display "" style(column)={cellwidth=40% asis=on} style(header)={just=l};
  define col1 / display "N" style(column)={cellwidth=6.7% just=c} style(header)={just=c};
  define col2 / display "Mean (SD)" style(column)={cellwidth=6.7% just=c} style(header)={just=c};
  define col3 / display "Change|from Bsln|Mean (SD)" style(column)={cellwidth=6.7% just=c} style(header)={just=c};
  define col4 / display "N" style(column)={cellwidth=6.7% just=c} style(header)={just=c};
  define col5 / display "Mean (SD)" style(column)={cellwidth=6.7% just=c} style(header)={just=c};
  define col6 / display "Change|from Bsln|Mean (SD)" style(column)={cellwidth=6.7% just=c} style(header)={just=c};
  define col7 / display "N" style(column)={cellwidth=6.7% just=c} style(header)={just=c};
  define col8 / display "Mean (SD)" style(column)={cellwidth=6.7% just=c} style(header)={just=c};
  define col9 / display "Change|from Bsln|Mean (SD)" style(column)={cellwidth=6.7% just=c} style(header)={just=c};
  %if &_lspaged > 0 %then %do;
  compute before _pagelbl / style={just=l};
    line _pagelbl $200.;
  endcomp;
  %end;
  break after _page / page;
run;
%mend _ls_report;
%_ls_report;
ods rtf close;
ods listing;
%ls_final_export;

14-6.01

Program t-14-6-01.sas

Program `t-14-6-01.sas`