| Pre-screening | Screening | Inclusion | Week | ||||
---|---|---|---|---|---|---|---|---|
 | 0 | 4 | 8 | 12 | 26 | |||
Patient attends the health clinic | Â | X | Â | X | Â | X | X | X |
Telephone review | Â | Â | Â | Â | X | Â | Â | Â |
Identification of eligible subjects | X | Â | Â | Â | Â | Â | Â | Â |
Check eligibility | Â | X | Â | Â | Â | Â | Â | Â |
Obtain informed consent | Â | Â | X | Â | Â | Â | Â | Â |
Blood sampling | Â | Â | Â | X | Â | X | Â | X |
Stool sampling | Â | Â | Â | X | Â | X | Â | X |
Provision of test product | Â | Â | Â | X | Â | X | X | Â |
Return of previously provided test product | Â | Â | Â | Â | Â | X | X | X |
Assessment of compliance and adverse events | Â | Â | Â | Â | X | X | X | X |