Table 4 Timeline of treatment assessments and interventions
Procedure | Screening (week 0) | Baseline (week 4) | Phone call (week 6) | Midpoint (week 10) | End of treatment (week 16) | Post-treatment follow-up (week 20) |
|---|---|---|---|---|---|---|
Informed consent | X | |||||
Inclusion and exclusion | X | |||||
Medical history | X | |||||
Screening blood test: LFT and U&E | X | |||||
Randomisation | X | |||||
Treatment/placebo dispensed | X | |||||
End of treatment blood test: LFT and U&E | X | |||||
Concomitant medication collection | X | X | X | X | X | |
Participants electronically fill out Endometriosis Pain Daily Diary v3 Scores | X | X | X | X | X | X |
Quality of life forms (SF-12, EQ-5D, EHP-30) | X | X | ||||
Fatigue severity scale (FSS) | X | X | ||||
Participant expectation and satisfaction questionnaire | X | X | ||||
Adverse events | X | X | X | X | ||
Dispense/return study drug | X | X | X |