Table 1.
The assessment schedule
| Visit 1 Screening |
Visit 2 Week 0 |
Week 2 | Visit 3 Week 4 |
Visit 4 Week 8 |
|
| Informed consent | X | ||||
| Inclusion/exclusion criteria | X | ||||
| Wash-out instructions | X | ||||
| Demographics | X | ||||
| Randomisation | X | ||||
| Study interventions (acetaminophen/loxoprofen/cerecoxib) |
|
||||
| Study medication history | X | X | |||
| Concomitant medication | X | X | X | X | |
| Physical examination | X | X | X | X | |
| Medical interview | X | X | X | X | |
| Vital signs | X | X | X | X | |
| Blood/urine examination | X | X | X | X | |
| PRO(BPI) | X | X | X | X | |
| PRO(GSRS) | X | X | X | X | |
| PRO(SF-8) | X | X | X | ||
| Adverse events | X | X | |||
BPI, Brief Pain Inventory; GSRS, Gastrointestinal Symptom Rating Scale; SF-8, Short Form-8.