Table 3.
Protocol activities and forms to be completed | Screening day –14 ± 2 |
Period 1 | Period 2 | ||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 | 23 | 24 | 25 | 26 | 27 | 28 | ||
Patient Information and Consent Form (to release medical information) | ✓ | ||||||||||||||||||||||||||||
Case Report Form (clinician) | ✓ | ||||||||||||||||||||||||||||
Demographic and Health Information Form | ✓ | ||||||||||||||||||||||||||||
IBS–D Daily Symptom Diary | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
IBS–D Symptom Event Log (if applicable) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
IBS–SSS | ✓ | ✓ | |||||||||||||||||||||||||||
IBS–QOL | ✓ | ✓ | |||||||||||||||||||||||||||
SF–12 | ✓ | ✓ | |||||||||||||||||||||||||||
PGI–C Week | ✓ | ||||||||||||||||||||||||||||
PGI–C Day | ✓ | ||||||||||||||||||||||||||||
PGI–S | ✓ | ✓ | ✓ | ✓ | ✓ |