Earley 2009.

Methods	Randomised, placebo‐controlled trial
Participants	18 adult men and women with RLS and PLMS > 15/hr, enrolled from a single medical centre (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: sodium chloride, given in the same infusion volume and with the same dosing schedule
Outcomes	IRLS (a secondary outcome), PLMS/hr by second night PSG, ferritin, global rating scale (7‐point scale of symptom severity completed by the participant), sleep diary, periodic limb movements during wake on the suggested immobilisation test, change in cerebrospinal fluid ferritin levels, 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	Randomised 2:1 but does not specify method of sequence generation
Allocation concealment (selection bias)	Low risk	Randomisation performed by pharmacy
Blinding (performance bias and detection bias) All outcomes	Low risk	Nurse and one investigator (CJE) knew treatment status at times but were not outcome assessors. IV solution and tubing wrapped with black opaque plastic to conceal solution
Incomplete outcome data (attrition bias) All outcomes	Low risk	All subjects who received interventions were analysed
Selective reporting (reporting bias)	Unclear risk	No study protocol available
Other bias	Low risk	No other risks identified; prior review rated high risk of bias for early stopping based on stopping rule, but this has been removed per current Cochrane guidance