CTR 945‐1008

Methods	Multicentre, randomised, double‐blind, placebo‐controlled, parallel‐group, no obvious enrichment, LOCF Titration from 300 mg/day to maximum tolerated dose or 3600 mg daily over 3 weeks, then stable dose for 12 weeks (15 weeks total)
Participants	Painful diabetic neuropathy. N =389, mean age 58 years, "more men than women". Pain duration > 3 months, PI at randomisation ≥ 40/100
Interventions	Gabapentin 3600 mg daily (max), n = 200 Placebo, n = 189
Outcomes	≥ 30% reduction in pain ≥ 50% reduction in pain Adverse events Withdrawals
Notes	Oxford Quality Score: R = 1, DB = 2, W = 1, Total = 4 Pfizer sponsored
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	Low risk	Matching placebo
Incomplete outcome data (attrition bias) Efficacy	Unclear risk	LOCF
Size Efficacy	Low risk	389 randomised
Study duration Efficacy	Unclear risk	14 weeks
Outcomes reported	Low risk	At least 50% reduction in pain