van Rij 1994.

Study characteristics
Methods	Study design: randomised, double‐blind trial. Intention‐to‐treat: yes Country: New Zealand Setting: outpatient clinic
Participants	Number randomised: N = 32 (EDTA n = 15; placebo n = 17) Exclusions post‐randomisation: none up to 3‐month assessment Losses to follow up: none up to 3‐month assessment Age (mean years ± SD): EDTA 67.7 ± 7.0; placebo 66.9 ± 6.7 Gender (M n (%)): EDTA 13 (87%); placebo 15 (88%) Inclusion criteria: intermittent claudication < 20% variation in measured walking distance over 3 consecutive assessments performed on different days, older than 45 years Exclusion criteria: other debilitating disease that affected walking, significant renal disease, diabetes mellitus
Interventions	Treatment: EDTA 3 g + MgCl 0.76 g + NaHCO3 0.84 g in 500 mL normal saline x 20 infusions Control: 500 mL normal saline x 20 infusions Both groups' infusions contained Parentrovite (thiamine hydrochloride 250 mg, riboflavine phosphate 5; 5 mg, pyridoxine hydrochloride 50 mg, ascorbic acid 500 mg, nicotinamide 160 mg, sodium pantothenate 5 mg, glucose anhydrous 1000 mg, sodium metabisulphite 4 mg); Both groups also received oral daily vitamin supplements. Duration of treatment: 10 weeks Follow up: after 10 infusions, 3, 6 and 12 months
Outcomes	Measured walking distance as total distance the participant was able to walk at 4 km/hr on a treadmill at 10% gradient to onset of pain or before stopping because of claudication Subjective walking distance as distance the participants considered able to walk before stopping because of claudication Ankle/brachial indices at rest and immediately after TET (12 weeks duration of observation)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were randomised in blocks of 10.
Allocation concealment (selection bias)	Low risk	Preparation of assigned infusions were conducted independently by the hospital pharmacist.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	As this was a double‐blind study with the infusions indistinguishable by container, labelling or colour, participant and personnel blinding was assured.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Assessments of participants and data were done by different staff groups who worked independently and were blind to treatment assignments.
Incomplete outcome data (attrition bias) All outcomes	Low risk	There were no complications or withdrawals from the study in either group up to the 3‐month assessment, but no indication of outcomes reported after 3 months of follow‐up.
Selective reporting (reporting bias)	Unclear risk	All initially stated outcomes were reported with between‐group analysis, but there was no evidence of outcomes reported at 6 and 12 months.
Other bias	Low risk	No other sources of bias were identified.

ABPI: ankle‐brachial pressure index (also known as ankle brachial index)
ECG: electrocardiogram
EDTA: ethylene diamine tetra‐acetic acid
eGFR: estimated glomerular filtration rate
MgCl: magnesium chloride
mmHg: millimetres of mercury
NaCl: sodium chloride
NaHCO3: sodium hydrogen carbonate
SD: standard deviation
TET: treadmill exercise test
VO₂: maximal oxygen uptake