NCT01272934.

Methods	R, DB, PC, parallel group study Gel applied 4 x daily
Participants	Acute lateral ankle sprain, Grade I to II, ≤ 12 hours N = 205 M 101, F 104 Mean (± SD) age 32 years (± 11) Baseline PI not reported
Interventions	Diclofenac sodium gel 1%, x 4 daily, n = 102 Placebo gel, x 4 daily, n = 103
Outcomes	Mean PI on movement Adverse events
Notes	Oxford Quality Score: R1, DB1, W1. Total = 3/5
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Method of blinding not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants accounted for
Size	Unclear risk	50 to 200 participants per treatment arm