Table 5.
Time and events of work package IV
| Screening | Work package IV | ||||
| Day −5 | Day 0 | Day 7 | |||
| Enrolment | Informed consent | X | |||
| In/exclusion criteria | X | ||||
| Objective examination | X | ||||
| Safety outcomes | Standard blood samples | X | |||
| Primary outcome | GI symptom questionnaires | X | X | ||
| Secondary outcomes | MRI scan of brain and GI tract | X | |||
| Continuous glucose monitoring |
|
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| Holter monitoring |
|
||||
| Sudomotor function | X | ||||
| Cardiovascular reflexes | X | ||||
| Inflammation markers | X | ||||
| Cardiac vagal tone | X | ||||
| Resting EEG | X | ||||
| QST | X | ||||
| GI transit |
|
||||
| Autonomic function questionnaire | X | ||||
EEG, electroencephalography; GI, gastrointestinal; QST, quantitative sensory testing.