Table 6 Subject diary ratings of breathing before and after strip application at bedtime (ITT population)

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 = 0.0254^c

P = 0.7624

P value for comparison with placebo

–

P = 0.0032^c

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 = 0.0208^c

P = 0.3799

P value for comparison with placebo

–

P = 0.0348^c

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 = 0.0011^c

P = 0.2497

P value for comparison with placebo

–

P = 0.0370^c

P = 0.1458

P value for comparison with BRNS

–

–

P = 0.0292^c

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 = 0.0009^c

P = 0.0438^c

P value for comparison with placebo

–

P = 0.0046^c

P = 0.0385^c

P value for comparison with BRNS

–

–

P = 0.1693

P value for comparison with BRNS

–

–

P = 0.4483