Published Online: November 15, 2014. doi:10.1001/jama.2014.14721.
Study concept and design: Knoll, Humar, Fergusson, Johnston, Ramsay, Zaltzman, Cockfield, Cantarovich, Karpinski, Gill.
Acquisition, analysis, or interpretation of data: Knoll, Humar, Fergusson, Johnston, House, Kim, Ramsay, Chassé, Pang, Lebel, Gill.
Drafting of the manuscript: Knoll, Humar, Fergusson, Chassé, Lebel, Gill.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Knoll, Fergusson, Ramsay, Chassé, Gill.
Obtained funding: Knoll, Humar, Fergusson, Kim, Gill.
Administrative, technical, or material support: Knoll, Humar, Johnston, Kim, Chassé, Pang, Zaltzman, Cantarovich, Lebel.
Study supervision: Knoll, Humar, Fergusson, Johnston, House, Cockfield, Lebel, Gill.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Knoll reported receiving investigator-initiated research grants from Astellas Canada and Pfizer Canada. Dr Kim reported receiving investigator-initiated research grants from Astellas Canada, Novartis Canada, and Genzyme Canada. Dr Humar reported receiving research grant support from Astellas Canada, Novartis Canada, and Roche Canada. Dr Cantarovich reported receiving grant support from Astellas Canada and Novartis Canada. Dr Gill reported receiving an investigator-initiated research grant from Astellas Canada and serving as a consultant for Astellas Canada. No other disclosures were reported.
Funding/Support: This project was funded by the Canadian Institutes of Health Research (CIHR) protocol 222493.
Role of the Funder/Sponsor: The CIHR had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.
Additional Contributions: We acknowledge the work of the members of the data and safety monitoring board: Brendan Barrett, MD (chair), Memorial University; Coleman Rotstein, MD, University of Toronto; and Lehana Thabane, PhD, McMaster University; research coordinators and participating centers: Erin McCarrell, St Paul’s Hospital, Vancouver; Jennie Chan, Vancouver General Hospital; Valerie Cronin, The Ottawa Hospital; Pinky Mathew and Jessica Pinder, Capital Health, Edmonton; Segun Famure and Nicholas Phan, University Health Network, Toronto; Michelle Nash, St Michael’s Hospital, Toronto; and Mary Jeanne Edgar, London Health Sciences Center; University of Alberta central laboratory: Yupin Tong, Edmonton; and Ottawa Hospital Research Institute data entry: Erin Murphy, Ottawa.