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. 2019 Sep 4;2019(9):CD005049. doi: 10.1002/14651858.CD005049.pub5

DAFNE 2003.

Methods RCT
Double‐blind
Loss to follow‐up reported: no
Participants Persistent AF (mean duration: 3 months). n = 199
Men: 70%
Age (mean): 63 years
Structural heart disease: NS. LAD: 45 mm. LVEF: 55%
Interventions Dronedarone various doses (800 mg/day, 1200 mg/day, 1600 mg/day) vs placebo
Method of AF cardioversion: pharmacological 15%, electrical 85%
Warfarin discretionary
Outcomes At 6 months:
Mortality
Proarrhythmia
Adverse effects
AF recurrence
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method used for randomisation not described.
Allocation concealment (selection bias) Unclear risk Method of concealment not detailed.
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Reported as a double‐blind trial, but no details provided.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Withdrawals because adverse events were reported, but other dropouts or lost to follow‐up were not well detailed.
Selective reporting (reporting bias) Low risk All prespecified outcomes and main outcomes of interest were adequately reported.
Other bias Low risk No other bias apparent.