Participant disposition
RLS
Opioid dose was iteratively reduced in three step-downs until the participant experienced an increase in RLS symptoms that was not addressable by TOMAC treatment. All 20 enrolled participants were included in the efficacy analysis population, including three participants who withdrew due to personal reasons and one who withdrew due to opioid withdrawal symptoms unrelated to RLS. It was determined retrospectively that one participant misreported their baseline opioid dose (actual dose was 64 MME); data from this participant were included in analyses with the corrected baseline dose. Step-down completion rate (Fig. Participant disposition. During TOMAC treatment, opioid dose was reduced iteratively in three consecutive step-downs – each lasting 2–3 weeks – until RLS symptoms increased (CGI-I > 5) or the participant was discontinued for other reasons. Abbreviations: CGI-I, clinical global impression of improvement; MME, morphine milligram equivalent; TOMAC, tonic motor activation