Table III. —Treatment outcomes based on the PP and ITT analyses.
Analysis | Total population |
Primary outcome | Secondary outcome | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Success | Failure | Improved | Unchanged | Progressed | ||||||||
N. | % | N. | % | N. | % | N. | % | N. | % | N. | % | |
ITT analysis | 82 | 100 | 64 | 78.0 | 18 | 22.0 | 50 | 61.0 | 23 | 28.0 | 9 | 11.0 |
PP analysis | 77 | 100 | 64 | 83.1 | 13 | 16.9 | 50 | 64.9 | 23 | 29.9 | 4 | 5.2 |
The primary outcome was defined as “success” when main curve was below 50° upon reaching skeletal maturity, and “failure” otherwise. The secondary outcome was classified as follow: 1) improved – reduction of main curve >5°; 2) unchanged – change of main curve ≤5°; 3) progressed – increase of main curve >5°. PP: per protocol; ITT: intention to treat.