Table 2.
Visit schedule
| Protocol Activity | V1 (Screening) | V1.5 (Screening) | Washout period | V2 (Arm 1) | V3 (Arm 1) | V4 (Arm 1) | Washout period | V5 (Arm 2) | V6 (Arm 2) | V7 (Arm 2) |
|---|---|---|---|---|---|---|---|---|---|---|
| Week (−2) | Week 0 | Week 2 | Week 4 | Week 0 | Week 2 | Week 4 | ||||
| Informed consent process | x | |||||||||
| Inclusion/Exclusion | x | |||||||||
| Medical history & physical exam | x | |||||||||
| Vital signs | x | x | x | x | x | x | x | x | ||
| Urine pregnancy test | x | |||||||||
| Standardized meals | x | x | x | x | x | x | x | |||
| Administer & review scales and questionnaires | x | x | x | x | x | x | ||||
| Review concomitant therapies | x | x | x | x | x | x | x | |||
| Intercurrent medical issues review | x | x | x | x | x | x | x | |||
| Randomization/study product preparation & dispensing | x | x | x | x | ||||||
| Hydrogen breath test | x | x | x | x | x | x | x | |||
| Fecal collection | x | x | x | x | x | x |