BI 2006.

Methods	Randomised controlled crossover trial of levodopa dual release versus pramipexole Dropouts/withdrawals: PP of 39 with 28 premature discontinuations
Participants	Included/analysed: 67/39 Demographics: 41% male, age 56.9 years Diagnosis: RLS according to IRLSSG, symptom presence almost every day, PLMI > 5 Setting: 6 Swiss centres including Basel, Bern, Lugano, Luzern, Zürich, Zurzach Baseline: IRLS score of 21.1 (levodopa) and 20.8 (ppx), PLMI (actigraphy) of 21.1 (levodopa) and 21.5 (ppx)
Interventions	Intervention 1: flexible uptitration of single dose pramipexole from 0.25 to 0.75 mg in 2 weeks, maintenance for 2 weeks Intervention 2: flexible uptitration of single dose levodopa‐dual‐release from 100/25 mg to 300/75 mg for 2 weeks, maintenance for 2 weeks 2 weeks washout between treatment periods
Outcomes	Change of symptoms: IRLS, CGI responders Objective quality of sleep: PLMI (using actigraphy) Safety: number of dropouts due to adverse events, number of patients with adverse events
funding source	The study was supported by Boehringer Ingelheim GmbH.
Notes	IRLS: International RLS Severity Rating Scale; ppx: pramipexole
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	Randomisation schedule was provided by BI Pharma GmbH & Co KG.
Allocation concealment?	Low risk	Medication package with the lowest available number was allocated to the patient.
Blinding? All outcomes	Unclear risk	Tablets were packaged in identical hard gelatine capsules, the code was restricted to authorised personnel, such as staff involved in packaging of study medication. Blinding of data analysts not reported.
Incomplete outcome data addressed? All outcomes	Low risk	Dropouts and reasons reported by BI on request.
Free of selective reporting?	Low risk	Results reported as prespecified.
Free of other bias?	Low risk	Low indication of other bias.