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. 2019 Jan 4;2019(1):CD007834. doi: 10.1002/14651858.CD007834.pub3

Lee 2014.

Methods Randomised, active‐comparator controlled trial
Participants 30 participants with RLS, ages 20‐80, with serum ferritin 15‐50 ng/mL, enrolled at a single site (Korea)
Interventions Intervention: oral ferrous sulfate, 325 mg bid, for 12 weeks
Control: oral pramipexole at bedtime, starting dose 0.25 mg with dose increase as needed and tolerated
Outcomes IRLS measured at baseline, weeks 2, 4, 8, and 12, ferritin, ESS score, Beck Depression Inventory, PSQI
Notes The authors calculated that > 20 subjects would be needed per group for 80% power to detect an effect size of 0.8
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Block randomisation used
Allocation concealment (selection bias) Unclear risk No mention of allocation concealment; study unblinded
Blinding (performance bias and detection bias) 
 All outcomes High risk Study was unblinded to participants and study personnel
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Although last observation carried forward was used, there was a high dropout rate for treatment‐related reasons that differed between conditions (4/15 dropped out of pramipexole group because of side effects versus 1/15 from iron group for lack of efficacy; an additional 2/15 left the iron group for study inconvenience)
Selective reporting (reporting bias) Unclear risk No mention of protocol registration
Other bias Low risk No other risks identified