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| TJ-14 | Placebo | P value | |
| Rate of OM (%) | 75.0 | 87.5 | 0.600 |
| Rate of OM ≥ G2 (%) (G2/G3/G4) |
37.5 (37.5/0/0) |
50.0 (25.0/25.0/0) |
0.580 |
| On set (day) | 9.7 | 6.7 | 0.258 |
| Duration of OM (day) | 4.7 | 6.7 | 0.522 |
| Duration of OM ≥ G2 (day) | 1.7 | 3.7 | 0.039 |
G2, grade 2; G3, grade 3; G4, grade 4.
