Earley 2009.

Methods	Randomized, controlled trial
Participants	18 adult men and women with RLS and PLMS >= 15/hr, enrolled from a single medical center (USA)
Interventions	Intervention: Iron sucrose, given as a 500 mL infusion (containing 500 mg iron sucrose) over 10 hours, then another 500 mL over 12 hours the following day. Placebo: NaCl, given in the same infusion volume & with the same dosing schedule
Outcomes	IRLS (a secondary outcome), PLMS/hr by 2nd night PSG, ferritin, global rating scale (7 pt scale of symptom severity completed by the patient), sleep diary, PLMW on SIT, change in CSF ferritin, change in MRI iron index in substantia nigra
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	randomized 2:1 but doesn't specify method of sequence generation
Allocation concealment (selection bias)	Low risk
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Nurse & MD knew treatment status; they were not the outcome assessors but did interact with some subjects
Incomplete outcome data (attrition bias) All outcomes	Low risk
Selective reporting (reporting bias)	Unclear risk	no study protocol available
Other bias	High risk	Stopped early due to data-dependent process (i.e., a stopping rule)