Trial-specific procedures | Screening | Baseline | Treat-ment | Observation | Post-study | ||
---|---|---|---|---|---|---|---|
Timeline | Day 0 | Day 2 | Day 3 | Day 4 | Colonoscopy from day 5 onwards | ||
Informed consent | X | ||||||
Inclusion/ exclusion criteria | X | ||||||
Randomization | X | ||||||
Physical examination | X | ||||||
Patient parametersa | X | ||||||
Blood sampling for biomarker analyses (optional)e | X | ||||||
Questionnaireb | X | ||||||
Handing over stool collection material and subject diaryc | X | ||||||
Drug administration (Acetylsalicylic acid or placebo) | X | ||||||
Stool sampled (FOBGold®Tube Screen) | X | X | X | X | |||
Stool sampled (FD Hb/Hp Complex) | X | X | X | X | |||
Concomitant therapy recording | X | X | X | X | |||
(S)AE recordingf | X | X | X | X |