Table 1.
Summary of demographic data—ITT population at the screening visit
| Demographic data | ITT population | ||||
|---|---|---|---|---|---|
| HA | 16 M | 32 M | 64 M | Total | |
| N (Missing) | 8 (0) | 17 (0) | 17 (0) | 15 (0) | 57 (0) |
| Age (year) | |||||
| Mean (SD) | 70.5 (8.37) | 67.7 (6.84) | 68.6 (6.45) | 64.9 (4.91) | 67.6 (6.60) |
| Median (IQR) | 73.5 (13.0) | 66.0 (5.0) | 68.0 (9.0) | 65.0 (8.0) | 67.0 (10.0) |
| Q1 ~ Q3 | 64.0 ~ 77.0 | 65.0 ~ 70.0 | 65.0 ~ 74.0 | 60.0 ~ 68.0 | 63.0 ~ 73.0 |
| Min ~ Max | 56.0 ~ 79.0 | 51.0 ~ 78.0 | 55.0 ~ 78.0 | 59.0 ~ 75.0 | 51.0 ~ 79.0 |
| p-value (T test) | – | 0.3835 | 0.5356 | 0.0531 | – |
| Gender | |||||
| Male | 3 (37.5%) | 3 (17.6%) | 2 (11.8%) | 3 (20.0%) | 11 (19.3%) |
| Female | 5 (62.5%) | 14 (82.4%) | 15 (88.2%) | 12 (80.0%) | 46 (80.7%) |
| p-value (FISHER) | – | 0.3442 | 0.2833 | 0.6214 | – |
| Body height (cm) | |||||
| Mean (SD) | 154.0 (12.42) | 154.7 (7.51) | 155.0 (6.75) | 156.5 (7.36) | 155.2 (7.92) |
| Median (IQR) | 148.8 (23.9) | 155.0 (7.5) | 153.5 (6.9) | 155.4 (8.5) | 154.2 (9.1) |
| Q1 ~ Q3 | 143.8 ~ 167.7 | 149.5 ~ 157.0 | 151.0 ~ 157.9 | 152.0 ~ 160.5 | 149.5 ~ 158.6 |
| Min ~ Max | 141.0 ~ 170.3 | 142.0 ~ 177.2 | 147.7 ~ 176.0 | 145.3 ~ 168.3 | 141.0 ~ 177.2 |
| p-value (Wilcox_t) | – | 0.5275 | 0.3907 | 0.4656 | – |
| Body weight (Kg) | |||||
| Mean (SD) | 60.5 (10.80) | 66.0 (6.80) | 64.2 (10.97) | 62.9 (10.47) | 63.9 (9.64) |
| Median (IQR) | 64.3 (18.5) | 65.0 (6.9) | 63.2 (13.1) | 63.8 (16.6) | 63.8 (12.9) |
| Q1 ~ Q3 | 49.4 ~ 67.8 | 62.0 ~ 68.9 | 56.4 ~ 69.5 | 55.7 ~ 72.3 | 56.6 ~ 69.5 |
| Min ~ Max | 46.2 ~ 74.6 | 55.6 ~ 77.4 | 48.0 ~ 87.2 | 42.3 ~ 80.2 | 42.3 ~ 87.2 |
| p-value (T test) | – | 0.1321 | 0.4293 | 0.6015 | – |
| BMI (Kg/m2) | |||||
| Mean (SD) | 25.47 (3.494) | 27.65 (3.026) | 26.72 (4.192) | 25.66 (3.782) | 26.54 (3.673) |
| Median (IQR) | 24.64 (3.89) | 28.28 (4.68) | 25.98 (3.68) | 25.67 (5.78) | 25.98 (5.22) |
| Q1 ~ Q3 | 23.33 ~ 27.21 | 25.03 ~ 29.70 | 24.56 ~ 28.24 | 22.90 ~ 28.68 | 23.83 ~ 29.05 |
| Min ~ Max | 21.09 ~ 32.29 | 23.14 ~ 32.26 | 20.37 ~ 34.59 | 19.39 ~ 31.33 | 19.39 ~ 34.59 |
| p-value (T test) | – | 0.1232 | 0.4724 | 0.9088 | – |
| Kellgren–Lawrence grade on target knee | |||||
| Grade II | 5 (62.5%) | 10 (58.8%) | 10 (58.8%) | 12 (80.0%) | 37 (64.9%) |
| Grade III | 3 (37.5%) | 7 (41.2%) | 7 (41.2%) | 3 (20.0%) | 20 (35.1%) |
| p-value (FISHER) | – | 1.0000 | 1.0000 | 0.6214 | – |
| Disease duration (years) | |||||
| Mean (SD) | 2.44 (2.367) | 2.97 (1.755) | 3.68 (7.198) | 2.39 (1.634) | 2.96 (4.164) |
| Median (IQR) | 2.05 (2.24) | 2.97 (2.13) | 2.04 (2.48) | 2.08 (2.48) | 2.26 (2.24) |
| Q1 ~ Q3 | 0.81 ~ 3.05 | 2.06 ~ 4.20 | 0.20 ~ 2.68 | 1.12 ~ 3.59 | 1.12 ~ 3.36 |
| Min ~ Max | 0.10 ~ 7.58 | 0.00 ~ 5.87 | 0.00 ~ 29.68 | 0.16 ~ 5.86 | 0.00 ~ 29.68 |
| p-value (Wilcox_t) | – | 0.3755 | 0.7514 | 0.8733 | – |
For CI and p-value (between groups), FISHER denotes Fisher's exact test, T denotes two-sample t-test, Wilcox_t denotes Wilcoxon rank-sum test (Mann–Whitney U Test) in t approximation