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

SAFE‐T 2005.

Methods RCT
Double‐blind
Loss to follow‐up reported: yes
Participants Persistent AF lasting 3 days to 1 year (mean duration: NS). n = 655
Men: 99%
Age (mean): 67 (SD 9) years
Structural heart disease: 33%. LAD: 48 mm. LVEF: 51%
Type of AF: persistent, mean duration: NS
Interventions Amiodarone 300 mg/day vs sotalol 320 mg/day vs placebo
Method of AF cardioversion: pharmacological 20%, electrical 80%
Outcomes At 12 months:
Mortality
Stroke
Proarrhythmia
AF recurrence
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated, permuted‐block randomisation, with stratification.
Allocation concealment (selection bias) Low risk Both the investigators and participants were unaware of the study‐group assignments.
Blinding (performance bias and detection bias) 
 All outcomes Low risk Double‐blind study, matching placebo.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Withdrawals and lost to follow‐up were well balanced and described.
Selective reporting (reporting bias) Low risk All prespecified and expected outcomes were adequately reported.
Other bias Low risk No other bias apparent.