Methods	Randomised, double blind, parallel group, no obvious enriched enrolment. Initial dose titration before fixed dose (13 weeks in total)
Participants	Painful diabetic neuropathy for at least 3 months, with average daily pain score of at least 40 mm/100 mm. Mean age 59 years, 57% male, majority white
Interventions	Pregabalin 300 mg daily, n = 153 Pregabalin 600 mg daily, n = 152 Placebo daily, n = 151
Outcomes	Proportion of patients with ≥ 30% or ≥ 50% decrease in mean pain score between endpoint and baseline, and other outcomes
Notes	Oxford quality score: R1, D2, W1 = 4/5 Pfizer sponsored
Risk of bias
Item	Authors’ judgement	Description
Adequate sequence generation?	Unclear	Stated to be randomised
Allocation concealment?	Unclear	Not described
Blinding? All outcomes	Yes	“matching placebo”