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Summary of Respiratory Adverse Events
| Year 1 | Year 2 | Year 3 | Year 4 | Year 5 | ||
|---|---|---|---|---|---|---|
| Number of subjects | BT | 45 a | 45 | 43 | 43 | 42 |
| Control | 24a | 24 | 21 | -- b | -- b | |
| Number of subjects reporting (Percent of subjects) | BT | 38 (84%) | 24 (53%) | 24 (56%) | 23 (53%) | 22 (52%) |
| Control | 18 (75%) | 13 (54%) | 12 (57%) | -- | -- | |
| Events per subject | BT | 4.5 | 1.2 | 1.3 | 1.2 | 1.1 |
| Control | 3.1 | 1.2 | 1.3 | -- | -- | |
a: Year 1 data only for subjects who enrolled for longer-term follow-up.
b: Control group subjects exited from Study after Year 3 evaluations.
