Table 1.
Study schedule
| 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 | |||
aAge, sex, weight, height, and blood pressure
bThe questionnaire includes questions on family history of CRC and lifestyle factors such as smoking and alcohol consumption
cEight kits are handed over
dIf stool collection on these days is not possible because of constipation or other reasons, stool collection may be postponed to the subsequent days; participants are also allowed to collect only two stool samples, which should be at baseline (without medication) and on day 2, if possible
eBlood sampling for biomarker analysis: 2 EDTA tubes; 2 serum tubes
fInterview of participants before colonoscopy