Table 1.
Adjusted mean change from baseline in DHEQ Section 1, Q7, Q8, Q9 scores at each time point compared to baseline (mITT population)
| Week comparison vs baseline | Adjusted mean differencea (95% CI) p-value | ||
|---|---|---|---|
| Q7: How intense were the sensations? | Q8: How bothered are you by the sensations? | Q9: How well can you tolerate the sensations? | |
| Week 4 | 0.88 (0.474, 1.295) < 0.0001 | 1.18 (0.703, 1.660) < 0.0001 | 0.43 (− 0.050, 0.919) 0.0786 |
| Week 8 | 1.28 (0.875, 1.690) < 0.0001 | 1.45 (0.977, 1.926) < 0.0001 | 0.69 (0.210, 1.717) 0.0050 |
| Week 12 | 1.74 (1.333, 2.145) < 0.0001 | 1.95 (1.473, 2.418) < 0.0001 | 1.40 (0.918, 1.875) < 0.0001 |
| Week 16 | 1.96 (1.545, 2.371) < 0.0001 | 2.33 (1.848, 2.810) < 0.0001 | 1.44 (0.951, 1.926) < 0.0001 |
| Week 20 | 2.06 (1.643, 2.469) < 0.0001 | 2.21 (1.732, 2.694) < 0.0001 | 1.17 (0.678, 1.653) < 0.0001 |
| Week 24 | 2.21 (1.794, 2.620) < 0.0001 | 2.50 (2.020, 2.982) < 0.0001 | 1.56 (1.072, 2.047) < 0.0001 |
aDifference is the baseline score minus respective Week score such that a positive difference shows an improvement in score; p-values in bold are significant