Day 1
|
Day 1
|
Mean (SD) before strip application
|
NA
|
NA
|
NA
|
Mean (SD) before strip application
|
34.58 (15.80)
|
27.85 (20.58)
|
34.00 (14.82)
|
Mean (SD) after strip application
|
1.20 (1.47)
|
2.45 (1.40)
|
1.42 (2.12)
|
Mean (SD) after strip application
|
43.11 (24.07)
|
61.55 (26.72)
|
55.00 (24.87)
|
LS mean after strip application
|
1.07
|
2.29
|
1.24
|
LS mean change after vs before strip application (95% CI); P value
|
7.37 (− 3.73 to 18.46); P = 0.1886
|
30.24 (19.38 to 41.10); P < 0.0001
|
19.21 (7.89 to 30.54); P = 0.0013
|
P value for comparison with placebo
|
–
|
P = 0.0254c
|
P = 0.7624
|
P value for comparison with placebo
|
–
|
P = 0.0032c
|
P = 0.1157
|
P value for comparison with BRNS
|
–
|
–
|
P = 0.0546
|
P value for comparison with BRNS
|
–
|
–
|
P = 0.1420
|
Day 3
|
Day 3
|
Mean (SD) before strip application
|
NA
|
NA
|
NA
|
Mean (SD) before strip application
|
37.95 (19.84)
|
29.35 (20.30)
|
45.11 (23.87)
|
Mean (SD) after strip application
|
1.20 (1.36)
|
2.40 (1.67)
|
1.74 (1.73)
|
Mean (SD) after strip application
|
48.53 (20.67)
|
58.90 (26.64)
|
61.42 (24.74)
|
LS mean after strip application
|
0.96
|
2.10
|
1.39
|
LS mean change after vs before strip application (95% CI); P value
|
8.67 (− 1.65 to 18.99); P = 0.0978
|
23.70 (13.42 to 33.97); P < 0.0001
|
17.10 (6.26 to 27.95); P = 0.0026
|
P value for comparison with placebo
|
–
|
P = 0.0208c
|
P = 0.3799
|
P value for comparison with placebo
|
–
|
P = 0.0348c
|
P = 0.2341
|
P value for comparison with BRNS
|
–
|
–
|
P = 0.1494
|
P value for comparison with BRNS
|
–
|
–
|
P = 0.3625
|
Day 7
|
Day 7
|
Mean (SD) before strip application
|
NA
|
NA
|
NA
|
Mean (SD) before strip application
|
36.37 (21.95)
|
32.10 (22.39)
|
40.53 (18.23)
|
Mean (SD) after strip application
|
1.20 (1.47)
|
2.80 (1.40)
|
1.79 (1.48)
|
Mean (SD) after strip application
|
47.42 (26.74)
|
58.95 (28.54)
|
61.11 (21.79)
|
LS mean after strip application
|
1.09
|
2.66
|
1.62
|
LS mean change after vs before strip application (95% CI); P value
|
8.75 (− 1.43 to 18.92); P = 0.0905
|
23.25 (13.21 to 33.29); P < 0.0001
|
18.89 (8.40 to 29.38); P = 0.0007
|
P value for comparison with placebo
|
–
|
P = 0.0011c
|
P = 0.2497
|
P value for comparison with placebo
|
–
|
P = 0.0370c
|
P = 0.1458
|
P value for comparison with BRNS
|
–
|
–
|
P = 0.0292c
|
P value for comparison with BRNS
|
–
|
–
|
P = 0.5278
|
Day 14
|
Day 14
|
Mean (SD) before strip application
|
NA
|
NA
|
NA
|
Mean (SD) before strip application
|
43.21 (24.00)
|
39.90 (24.07)
|
45.89 (22.29)
|
Mean (SD) after strip application
|
0.89 (1.41)
|
2.70 (1.66)
|
2.00 (1.72)
|
Mean (SD) after strip application
|
51.05 (25.39)
|
68.70 (26.64)
|
67.56 (23.61)
|
LS mean after strip application
|
0.74
|
2.54
|
1.82
|
LS mean change after vs before strip application (95% CI); P value
|
4.15 (− 5.70 to 14.01); P = 0.4017
|
23.52 (13.82 to 33.23); P < 0.0001
|
18.43 (8.14 to 28.72); P = 0.0007
|
P value for comparison with placebo
|
–
|
P = 0.0009c
|
P = 0.0438c
|
P value for comparison with placebo
|
–
|
P = 0.0046c
|
P = 0.0385c
|
P value for comparison with BRNS
|
–
|
–
|
P = 0.1693
|
P value for comparison with BRNS
|
–
|
–
|
P = 0.4483
|