Table 1

Schedule of events

Time of assessment
Screening
(pre-enrolment)		Baseline
(prior to intervention)		Days 1–6Day 7Days 8–13Day 14Days 15–20Day 21Week
4		Week
8		Week 12
Eligibility✓          
Informed consent✓          
Randomisation ✓         
Medical history and current medications ✓         
Demographics ✓         
Study intervention  ✓✓✓✓✓✓   
EQ-VAS  ✓✓✓✓✓✓   
Symptom questionnaire  ✓✓✓✓✓✓   
EQ-5D-5L ✓ ✓ ✓ ✓✓✓✓
Phone call follow-up

  • Concomitant Medications

  • Adverse events

  • Hospitalisations

  • Delayed return to usual health

   ✓ ✓ ✓✓✓✓

  • EQ-VAS and symptom questionnaires must be filled in on the appropriate days. A 3-day window will be allowed for EQ-5D-5L completion and phone call follow-up for the first 4 weeks. The window will increase to 5 days for weeks 8 and 12. Compliance to the intervention will be participant-reported and take place on day 21 or week 4.

  • EQ-5D-5L, EuroQol 5-Dimension 5-Level; EQ-VAS, EuroQol Visual Assessment Scale.