| Telephone assessment (≥ week − 1) | Baseline assessment (week 0) | Treatment period | Week 8 | Week 12 |
---|---|---|---|---|---|
Eligibility | x | x | Â | Â | Â |
Randomization | x | Â | Â | Â | Â |
Informed consent | Â | x | Â | Â | Â |
Demographics | Â | x | Â | Â | Â |
Medical history | x | x | x | x | x |
Medications | x | x | x | x | x |
Device issue and familiarization | Â | x | Â | Â | Â |
Device usage | Â | x | x | x | Â |
COPM | Â | x | Â | x | x |
Symptom (heaviness, aching, tiredness, and cramps) scores | Â | x | Â | x | x |
Leg pain | Â | x | Â | x | x |
Doppler ultrasound | Â | x | Â | xa | Â |
Adverse events | Â | x | x | x | x |