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. 2016 Sep 29;2016(9):CD011790. doi: 10.1002/14651858.CD011790.pub2

Arnold 2014.

Methods 13‐week multicentre, controlled‐release, double‐blind, placebo‐controlled, EERW trial
Participants Fibromyalgia according to ACR classification and pain diary score ≥ 4 on 11‐point numerical rating scale
N = 441 entered titration phase, 121 randomised to double‐blind phase
Mean age 50 years, 91% female, 90% white
Baseline mean pain score: 6.8/10
Interventions 4 phases: 1) baseline (1 week), 2) single‐blind (participants were blinded) treatment (6 weeks), 3) double‐blind treatment (13 weeks), and 4) a double‐blind taper period (1 week)
Pregabalin controlled release 330 to 495 mg daily, n = 63
Placebo, n = 58
Outcomes PI on an 11‐point numerical rating scale, using daily pain diary
Adverse events
Withdrawals
Notes Pfizer sponsored
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 Not described, "randomly assigned"
Allocation concealment (selection bias) Low risk "telephone using the Interactive Voice Recognition System (IVRS)"
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Stated to be double blind. Used a matching placebo
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Stated to be double blind. Used a matching placebo
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All participants included in analysis
Selective reporting (reporting bias) Low risk All relevant outcomes reported
Size Unclear risk 50 to 199 participants per treatment arm (58, 63)