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Safety Stopping Rules
| Adverse Event | Stopping Rule |
|---|---|
| Major hemoptysis | > 3 of first 100 subjects then |
| > 3% subjects or | |
| > 2 subjects/study site | |
| Respiratory failure | > 15 of first 100 subjects then |
| > 15% subjects or | |
| > 2 subjects/study site | |
| Pneumothorax | > 4 of first 20 subjects then |
| > 20% subjects or | |
| > 2 subjects/study site | |
| Death | ≥2 of first 66 subjects within 30 days post procedure or >3% thereafter |
