Mease 2008.

Methods	12‐week multicentre, randomised, double‐blind, placebo‐controlled, parallel‐group trial
Participants	Fibromyalgia according to ACR classification and pain of at least 40/100 mm in week before randomisation N = 748 Mean age 49 years, 94% female, 90% white Baseline mean pain: 7.1/10
Interventions	1‐week dose escalation (all participants started at 150 mg), 12 weeks with fixed dose Pregabalin 300 mg daily, n = 185 Pregabalin 450 mg daily, n = 183 Pregabalin 600 mg daily, n = 190 Placebo daily, n = 190
Outcomes	Proportion of participants with ≥ 50% decrease in mean pain score PGIC (7‐point scale from very much improved to very much worse) between endpoint and baseline Adverse events Withdrawals
Notes	Pfizer sponsored. LOCF used to account for missing data and participant withdrawn Oxford Quality Score: R2, DB2, W1. Total = 5/5
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Stated to be randomised. Method of sequence generation not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Stated to be double blind, method not described
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Stated to be double blind, method not described
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	LOCF imputation
Selective reporting (reporting bias)	Low risk	All relevant outcomes reported
Size	Unclear risk	50 to 199 participants per treatment arm (183 to 190)