Krayenbuehl 2011.

Methods	RCT; parallel‐group (phase III). Undertaken in 4 centres in a single country
Participants	Premenopausal, menstruating women 18 years of age who presented with fatigue were evaluated for inclusion in the study. Inclusion criteria were serum ferritin concentration < 50 ng/mL, Hb concentration > 120 g/L, and adequate contraception for the study period.
Interventions	4 infusions containing study drug (200 mg iron sucrose) or an equivalent volume of placebo (0.9% sodium chloride) over 2 weeks
Outcomes	Primary outcome was change in BFI score between baseline and end of follow‐up (week 12). Additional data on Hb, ferritin, TSAT and adverse events were collected.
Study funding arrangements	"This study was funded by Vifor Pharma (Villars‐sur‐Glane, Switzerland). The sponsor of the study was involved in the study design and was responsible for data collection and storage. The study authors had full access to all data and were responsible for the analysis and interpretation of the data presented in this publication."
Author conflicts of interest	1 study author is a consulting expert for Vifor Pharma in the field of obstetrics and gynaecology.
Sample size	90 participants were randomised to receive the intervention (n = 43) or the control (n = 47) treatment.
Notes	Study was registered with a public trials register (ISRCTN 78430425)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "The randomisation schedule was generated by Cardinal Health Germany GmbH (Schorndorf, Germany). In total, 172 randomisation numbers were generated." Comment: no comment made on precise nature of randomisation schedule
Allocation concealment (selection bias)	Unclear risk	Comment: no comment made on nature of allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "The study medication was prepared and administered by a staff member other than the investigator. Both the infusion bag and the injection site were covered and nontransparent tubing was used, ensuring that the patient could not see the infusion solution at any time. The investigator was not present during the infusion."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The study medication was prepared and administered by a staff member other than the investigator. Both the infusion bag and the injection site were covered and nontransparent tubing was used, ensuring that the patient could not see the infusion solution at any time. The investigator was not present during the infusion."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: all exclusions between enrolment and end of study accounted for and ITT/per protocol analyses performed
Selective reporting (reporting bias)	High risk	Comment: all outcomes reported. BFI baseline data not reported as median (IQR), but in fatigue form only. Data suggest that iron group may have had lower levels of fatigue at outset of study. P value for this difference not reported.
Other bias	High risk	Comment: extensive drug company funding for study. Drug company was sponsor and custodian of data.