Study procedures | Screeninga | Inclusiona | 1 month Call + or – 14 days |
---|---|---|---|
Written Informed Consent | X | Â | Â |
Review of Inclusion / non inclusion Criteria | X | X | Â |
Digestive Status | X | X | Â |
Medical History & Demographics | X | Â | Â |
Physical Exam | X | X | Â |
Vital Signs | X | X | Â |
Blood (safety ANSM) | Â | X | Â |
Stool samples, donation stool (safety ANSM) | Â | X | Â |
Fecalotheque | Â | X | Â |
Concomitant treatment | X | X | Â |
Screening survey | X | Â | Â |
Lightened survey | Â | X | Â |
Safety survey | Â | Â | X |