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

Cho 2016.

Methods Randomised, placebo‐controlled trial
Participants 64 adult men and women with at least moderately severe RLS (IRLS >= 15) and symptoms at least 5 nights/week, enrolled from a single centre (Republic of Korea)
Interventions Intervention: 1000 mg of ferric carboxymaltose, given intravenously in 100 mL normal saline over 15 minutes, as a single dose
Placebo: 100 mL normal saline over 15 minutes, as a single dose
Outcomes IRLS, VAS of symptom severity, PSQI, RLS‐QoL, SF‐36, ferritin
Notes Funded by pharmaceutical company
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer random number generator
Allocation concealment (selection bias) Unclear risk May have used an open random allocation scheduled, i.e. "random number sequence"
Blinding (performance bias and detection bias) 
 All outcomes Low risk Nurse who administered intervention was unblinded but did not assess outcomes. IV bottles and lines were covered with foil to prevent identification of FCM versus placebo
Incomplete outcome data (attrition bias) 
 All outcomes Low risk One participant dropped out prior to receiving medications (not analysed). Two participants dropped out after receiving only one dose (included in safety set but not efficacy analyses). Three dropouts from ferric carboxymaltose and one from placebo group, all because of RLS severity. Included in analyses using last observation carried forward
Selective reporting (reporting bias) Unclear risk No mention of protocol registration
Other bias Low risk No other risks identified