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| VSL#3 number of patients (%) | Placebo number of patients (%) | |
|---|---|---|
| Lack of efficacy | 0 (0.0) | 5 (6.8) |
| Clinical episode | 0 (0.0) | 0 (0.0) |
| Abnormal laboratory result | 0 (0.0) | 0 (0.0) |
| Death | 0 (0.0) | 0 (0.0) |
| Protocol violation | 2 (1.4) | 0 (0.0) |
| Lost to follow-up | 3 (4.2) | 1 (1.4) |
| Protocol interim criteria not met | 0 (0.0) | 0 (0.0) |
| Patient's consent withdrawn | 2 (2.8) | 1 (1.4) |
