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

Trenkwalder 2017.

Methods Randomised, placebo‐controlled trial
Participants 110 participants with at least moderately severe RLS (IRLS >= 15) and serum ferritin less than 75 ng/mL (or serum ferritin 75‐300 ng/mL and transferrin saturation < 20%)
Interventions Intervention: intravenous ferric carboxymaltose, 1000 mg infusion over 15 minutes
Control: placebo with matched infusion rate
Outcomes IRLS, CGI‐severity, PGI‐C, RLS‐6 quality of life scale, MOS sleep
Notes Funded by pharmaceutical company
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised by statistician
Allocation concealment (selection bias) Low risk Central allocation
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Nurse administering treatment was not blinded but did not assess outcomes. Unclear how treatment was concealed during IV administration
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Relatively high dropout rate (21%), but for similar reasons and used last observation carried forward
Selective reporting (reporting bias) Low risk Protocol registered on EudraCT prior to start of enrolment; protocol consistent with reported outcomes
Other bias Low risk No other risks identified