Participant timeline and schedule of study procedures
| Timepoint | Screening and baseline | Week 1 | Weeks 4–5 | Week 6 | Week 12 | Week 16 |
| ENROLMENT: | ||||||
| Eligibility screening by research staff and study physician | X | |||||
| Informed consent | X | |||||
| Allocation | X | |||||
| INTERVENTIONS: | ||||||
| Study drug (LDN or placebo) | X | X | X | X | X | X |
| Study drug diary (daily for first 4 weeks and for 7 days after any change in dose) | X | X | X | |||
| VISITS: | ||||||
| Adverse effects check | X | X | X* | X* | X | |
| Monitor study drug use | X | X | X* | X* | X | |
| ASSESSMENTS: | ||||||
| Questionnaires† | X | X | X | X | ||
| Laboratory investigations | X | X | ||||
| Pedometer (number of steps per day) | X | X | ||||
| Hand grip (muscle strength)‡ | X | X | ||||
| Blood pressure and heart rate‡ | X | X | ||||
| Sit and stand test‡ | X | X |
This table outlines the schedule of study procedures. See figure 1 for timeline of recruitment, eligibility screening and baseline assessments.
*Occurs as part of questionnaires if optional visit does not occur.
†Short answer questionnaire for demographic and clinical information is done at baseline only.
‡Only for those agreeing to have in-person visits.
LDN, low dose naltrexone.