Table 4 Change in safety parameters from baseline to 6-month end point ^a

SAS total score, mean (SD)

(n = 46)

(n = 180)

(n = 48)

(n = 274)

Baseline

0.03 (0.12)

0.11 (0.24)

0.17 (0.28)

0.11 (0.23)

Change

-0.01 (0.19)

-0.01 (0.28)

-0.05 (0.26)

-0.02 (0.27)

BARS global rating score, n (%)

Baseline

(n = 47)

(n = 180)

(n = 48)

(n = 275)

Absent or questionable

46 (98)

173 (96)

48 (100)

267 (97)

Mild to moderate akathisia

1 (2)

6 (3)

0

7 (3)

Marked to severe akathisia

0

1 (1)

0

1 (<1)

Month 6 end point

(n = 47)

(n = 181)

(n = 50)

(n = 278)

Absent or questionable

47 (100)

176 (97)

50 (100)

267 (98)

Mild to moderate akathisia

0

5 (3)

0

5 (2)

Marked to severe akathisia

0

0

0

0

AIMS, mean (SD)

(n = 46)

(n = 180)

(n = 50)

(n = 276)

Baseline

0.4 (1.3)

0.6 (1.8)

0.9 (2.2)

0.6 (1.8)

Change

-0.4 (1.3)

-0.2 (1.4)

-0.3 (2.2)

-0.3 (1.5)

Prolactin, male subjects, mean (SD), ng/mL

(n = 28)

(n = 159)

(n = 28)

(n = 215)

Baseline

18.6 (24.7)

40.4 (26.3)

55.8 (25.3)

39.6 (27.6)

Change

29.1 (32.6)

3.7 (28.5)

-6.2 (22.2)

5.7 (29.8)

Prolactin, female subjects, mean (SD), ng/mL

(n = 13)

(n = 104)

(n = 18)

(n = 135)

Baseline

14.3 (6.7)

73.6 (43.0)

100.3 (62.3)

71.5 (48.5)

Change

83.4 (44.7)

11.5 (43.3)

-14.0 (49.3)

15.0 (50.1)

Glucose, mean (SD), mmol/L

(n = 46)

(n = 267)

(n = 46)

(n = 359)

Baseline

5.1 (0.5)

5.1 (0.7)

5.3 (0.5)

5.2 (0.6)

Change

0.2 (0.8)

0.1 (1.5)

0.0 (0.9)

0.1 (1.4)

HDL, mean (SD), mmol/L

(n = 22)

(n = 215)

(n = 46)

(n = 283)

Baseline

1.0 (0.2)

1.3 (0.3)

1.4 (0.4)

1.3 (0.4)

Change

-0.04 (0.2)

-0.05 (0.2)

-0.03 (0.2)

-0.04 (0.2)

LDL, mean (SD), mmol/L

(n = 22)

(n = 214)

(n = 46)

(n = 282)

Baseline

2.2 (0.7)

2.4 (0.7)

2.3 (0.5)

2.4 (0.7)

Change

-0.04 (0.4)

0.01 (0.6)

0.04 (0.5)

0.01 (0.5)

Total cholesterol, mean, (SD), mmol/L

(n = 46)

(n = 271)

(n = 47)

(n = 364)

Baseline

4.09 (1.07)

4.19 (0.77)

4.20 (0.71)

4.18 (0.81)

Change

0.02 (0.59)

-0.04 (0.73)

-0.03 (0.61)

-0.04 (0.69)

Triglycerides, mean (SD), mmol/L

(n = 46)

(n = 271)

(n = 47)

(n = 364)

Baseline

1.19 (0.71)

1.13 (0.58)

1.21 (0.65)

1.15 (0.61)

Change

0.07 (0.58)

-0.00 (0.64)

-0.09 (0.72)

-0.01 (0.64)

Leptin, mean (SD), μg/L

(n = 21)

(n = 217)

(n = 47)

(n = 285)

Baseline

11.4 (11.1)

13.1 (14.2)

12.3 (14.3)

12.9 (14.0)

Change

6.5 (12.8)

2.0 (9.3)

2.6 (7.2)

2.4 (9.3)

Height, mean (SD), cm

(n = 44)

(n = 278)

(n = 49)

(n = 371)

Baseline

163.9 (10.2)

167.3 (11.4)

173.0 (9.8)

167.6 (11.3)

Change

0.9 (1.3)

1.0 (1.6)

1.1 (1.5)

1.0 (1.6)

Weight, mean (SD), kg

(n = 44)

(n = 278)

(n = 49)

(n = 371)

Baseline

60.2 (21.3)

62.6 (13.7)

67.6 (14.3)

63.0 (14.9)

Change

4.3 (5.5)

3.9 (5.3)

4.5 (5.8)

4.0 (5.4)

BMI, mean (SD), kg/m²

(n = 44)

(n = 278)

(n = 49)

(n = 371)

Baseline

22.0 (5.9)

22.2 (3.7)

22.5 (3.9)

22.2 (4.0)

Change

1.4 (1.9)

1.1 (1.9)

1.2 (1.7)

1.2 (1.8)