Table 2 Patient-reported outcomes at baseline and week 4

HIT-6 total score, n^a

226

232

 Baseline, mean (SD)

65.1 (4.97)

64.8 (5.01)

 Week 4, mean (SD)

57.0 (9.74)

61.1 (7.83)

 Change from baseline, LS mean (95% CI)

−8.7 (− 10.1, − 7.3)

−4.5 (− 5.9, − 3.1)

  Difference from placebo, LS mean (95% CI)^b

− 4.2 (− 5.7, − 2.6)

  P-value vs placebo

< .0001

mTOQ-6 total score, n^a

226

231

 Baseline, mean (SD)

18.1 (4.05)

18.6 (4.20)

 Week 4, mean (SD)

20.1 (4.21)

19.6 (4.22)

 Change from baseline, LS mean (95% CI)

2.1 (1.5, 2.6)

1.2 (0.7, 1.7)

  Difference from placebo, LS mean (95% CI)^b

0.9 (0.3, 1.5)

  P-value vs placebo

.0053

PGIC rating at week 4, n^a

226

232

 Very much improved, n (%)

56 (24.8)

29 (12.5)

 Much improved, n (%)

78 (34.5)

31 (13.4)

 Minimally improved, n (%)

54 (23.9)

58 (25.0)

 No change, n (%)

35 (15.5)

109 (47.0)

 Worse, n (%)^c

3 (1.3)

5 (2.1)