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Data of safety monitoring in and placebo groups during the study.
| Variables | Placebo group (n = 24) | IP group (n = 120) | P value | ||
|---|---|---|---|---|---|
| n | % | n | % | ||
| Stool culture received (n) | 24 | 100 | 120 | 100 | 1.0 |
| Positive stool cultures (n) | 0 | 0 | 0 | 0 | 1.0 |
| Initiated antibiotics treatment (n) | 2 | 8.3 | 5 | 4.1 | 0.044 |
