Author Contributions: Drs Mitchell and Exner and Ms Connolly had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Mitchell, Exner, Wyse, Maitland.
Acquisition of data: Mitchell, Exner, Connolly, Prystai, Bayes, Kidd, Kieser, Burgess, Ferland, MacAdams, Maitland.
Analysis and interpretation of data: Mitchell, Exner, Wyse, Connolly.
Drafting of the manuscript: Mitchell, Exner, Connolly.
Critical revision of the manuscript for important intellectual content: Mitchell, Exner, Wyse, Connolly, Prystai, Bayes, Kidd, Kieser, Burgess, Ferland, MacAdams, Maitland.
Statistical analysis: Mitchell, Exner, Connolly.
Obtained funding: Mitchell, Exner, Connolly.
Administrative, technical, or material support: Mitchell, Wyse, Connolly, Prystai, Bayes, Kidd, Kieser, Burgess, Ferland, MacAdams, Maitland.
Study supervision: Mitchell, Exner, Wyse, Connolly.
Financial Disclosures: Dr Wyse has been a consultant to Sanofi-Aventis and Biovail Pharma; served on the scientific advisory board for Medtronic and Boehringer Ingelheim; served as a speaker for Cardiome/Astellas, Medtronic, Sanofi-Aventis, Chugai Pharma, Biovail Pharma, Daiichi Pharma; and owns stock in Cardiome. None of the other authors reported disclosures.
Funding/Support: The PAPABEAR pilot study was funded by the Heart and Stroke Foundation of Alberta, NWT, and Nunavut. The main PAPABEAR trial was funded by grant MCT-14764 from the Canadian Institutes for Health Research. Amiodarone and it matching placebo were supplied by Wyeth-Ayerst Canada Inc. Dr Exner is a clinician-scientist for the Canadian Institutes of Health Research and a clinical investigator for the Alberta Heritage Foundation for Medical Research.
Role of the Sponsor: The funding agencies had no role in the design or conduct of the study, in the collection, analysis, and interpretation of the data, or in the preparation, review, or approval of the manuscript.
Acknowledgment: We are indebted to the staff of the cardiac surgery preoperative clinic, cardiac surgery operating rooms, cardiac surgery intensive care unit, and cardiac surgery ward for their major contributions to the PAPABEAR trial.