Table 2 Summary of blinding status
| Â | Blinding status | Comments |
|---|---|---|
Participants | Not blinded | Not possible to blind participants, efforts will be made to minimise expectation bias |
Research nurses and PI | Blinded | Participants will be reminded in their clinic appointment letters not to wear the clothing when they attend the clinic, or to mention the clothing in any way when talking to the research nurses |
Trial staff at Nottingham CTU | Not blinded | Will be the main point of contact for participants wishing to contact the research team, will package and post the clothing to the participants according to the randomisation schedule, and will provide general advice |
Statistician | Blinded | Statistician will finalise the analysis plan prior to revealing the treatment codes |