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