Sleep problems
b
|
Mean (SD) at baseline
|
15.10 (6.66)
|
14.30 (4.57)
|
13.63 (5.96)
|
Day 7
|
LS mean change from baseline (95% CI)
|
− 4.19 (− 6.18 to − 2.21)
|
− 7.40 (− 9.44 to − 5.36)
|
− 6.56 (− 8.71 to − 4.42)
|
P value for comparison with placebo
|
–
|
P = 0.0221c
|
P = 0.0942
|
P value for comparison with BRNS
|
–
|
–
|
P = 0.5462
|
Day 14
|
LS mean change from baseline (95% CI)
|
− 5.74 (− 7.74 to − 3.74)
|
− 7.62 (− 9.68 to − 5.57)
|
− 7.05 (− 9.21 to − 4.89)
|
P value for comparison with placebo
| |
P = 0.1739
|
P = 0.3524
|
P value for comparison with BRNS
| | |
P = 0.6804
|
Sleep time problems
d
|
Mean (SD) at baseline
|
15.75 (6.99)
|
15.45 (5.99)
|
15.84 (7.95)
|
Day 7
|
LS mean change from baseline (95% CI)
|
− 5.64 (− 8.09 to − 3.19)
|
− 7.49 (− 9.99 to − 5.00)
|
− 8.21 (− 10.81 to − 5.61)
|
P value for comparison with placebo
|
–
|
P = 0.2722
|
P = 0.1354
|
P value for comparison with BRNS
|
–
|
–
|
P = 0.6731
|
Day 14
|
LS mean change from baseline (95% CI)
|
− 7.05 (− 9.49 to − 4.61)
|
− 8.75 (− 11.24 to − 6.26)
|
− 6.77 (− 9.36 to − 4.18)
|
P value for comparison with placebo
|
–
|
P = 0.3136
|
P = 0.8677
|
P value for comparison with BRNS
|
–
|
–
|
P = 0.2463
|
Symptoms on waking in the morning
e
|
Mean (SD) at baseline
|
16.55 (6.25)
|
15.80 (4.42)
|
14.74 (4.94)
|
Day 7
|
LS mean change from baseline (95% CI)
|
− 4.07 (− 6.13 to − 2.02)
|
− 7.20 (− 9.28 to − 5.11)
|
− 7.91 (− 10.09 to − 5.72)
|
P value for comparison with placebo
|
–
|
P = 0.0298c
|
P = 0.0099c
|
P value for comparison with BRNS
|
–
|
–
|
P = 0.6195
|
Day 14
|
LS mean change from baseline (95% CI)
|
− 5.32 (− 7.33 to − 3.30)
|
− 7.86 (− 9.90 to − 5.81)
|
− 8.00 (− 10.14 to − 5.86)
|
P value for comparison with placebo
|
–
|
P = 0.0695
|
P = 0.0614
|
P value for comparison with BRNS
|
–
|
–
|
P = 0.9183
|
Practical problems
f
|
Mean (SD) at baseline
|
7.25 (4.99)
|
6.05 (4.36)
|
6.53 (5.21)
|
Day 7
|
LS mean change from baseline (95% CI)
|
− 2.28 (− 3.51 to − 1.04)
|
− 2.77 (− 4.02 to − 1.52)
|
− 3.08 (− 4.38 to − 1.78)
|
P value for comparison with placebo
|
–
|
P = 0.5564
|
P = 0.3500
|
P value for comparison with BRNS
|
–
|
–
|
P = 0.7211
|
Day 14
|
LS mean change from baseline (95% CI)
|
− 3.21 (− 4.34 to − 2.07)
|
− 3.59 (− 4.74 to − 2.44)
|
− 3.05 (− 4.25 to − 1.86)
|
P value for comparison with placebo
|
–
|
P = 0.6223
|
P = 0.8454
|
P value for comparison with BRNS
|
–
|
–
|
P = 0.4947
|