Table 1 Schedule of assessments and procedures
Procedure | Study Day | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Â | Screening baseline Day 1* | Telephone contact 1 Day 2 | Telephone contact 2 Day 3 | Visit Day 4 | Visit Day 7* | Visit Day 14* | Visit Day 21* | Visit Day 28* | Final Visit Week 12 * |
Informed consent | x | - | - | - | - | - | - | - | - |
Eligibility criteria | x | - | - | - | - | - | - | - | - |
Study registration | x | - | - | - | - | - | - | - | - |
Medical history | x | - | - | - | - | - | - | - | x |
Physical examination | x | - | - | x | x | x | x | x | x |
Analgesic consumption | x | - | - | - | x | x | x | x | x |
Pain assessment (BPI) | x | x | x | x | x | x | x | x | x |
Symptoms and Side effects assessment | x | x | x | x | x | x | x | x | x |
Patient global assessment | x | - | - | - | x | x | x | x | x |
Physician global assessment | x | - | - | Â | x | x | x | x | x |
HRQOL | x | - | - | - | x | x | x | x | x |