Study periods | Admission | 1st contact | 2nd contact | Eligibility | Assessment | Treatment | Follow-up |
---|---|---|---|---|---|---|---|
Visit Duration | Week 1 | Week 1 | Week 1 | Week 1 | Week 1 | Week 2–5 | Week 6 |
10 min | 10 min | 1 hour | 3 hours | (4 × 5 × 30 min) | 3 hours | ||
Time | −7d | −6d | −5d | −4d | −4-0d | −2d | 27d |
Admission | x | Â | Â | Â | Â | Â | Â |
Medical examination | x | Â | Â | Â | Â | Â | Â |
Patient information | Â | x | Â | Â | x | Â | Â |
Consultation | Â | Â | x | Â | Â | Â | Â |
Informed consent | Â | Â | Â | x | Â | Â | Â |
Demographics | Â | Â | Â | x | Â | Â | Â |
Medical history | Â | Â | Â | x | Â | Â | Â |
In-/exclusion Criteria | Â | Â | Â | x | Â | Â | Â |
Randomisation | Â | Â | Â | Â | Â | x | Â |
Administer study | Â | Â | Â | Â | Â | x | Â |
Primary variables | Â | Â | Â | Â | x | Â | x |
Secondary variables | Â | Â | Â | Â | x | Â | x |
Concomitant therapy | Â | Â | Â | Â | Â | x | Â |
Adverse events | Â | Â | Â | Â | Â | x | x |