Author Contributions: Dr Chanoine had full
access to all of the data in the study and takes responsibility for the integrity
of the data and the accuracy of the data analysis.
Study concept and design: Boldrin, Hauptman.
Acquisition of data: Chanoine, Hampl, Jensen,
Analysis and interpretation of data: Chanoine,
Hampl, Jensen, Boldrin, Hauptman.
Drafting of the manuscript: Boldrin, Hauptman.
Critical revision of the manuscript for important
intellectual content: Chanoine, Hampl, Jensen, Hauptman.
Statistical analysis: Boldrin.
Administrative, technical, or material support:
Study supervision: Chanoine, Jensen, Hauptman.
Financial Disclosures: Dr Chanoine has received
honoraria from Hoffmann-La Roche for speakers presentations. No other authors
reported financial disclosures.
Funding/Support: This study was funded by F.
Hoffmann-La Roche Ltd.
Independent Statistical Review: All study data
were transferred from Hoffman-La Roche to the Department of Statistics at
the British Columbia Children’s Hospital for independent reanalysis.
Statistical reanalyses of the raw data were performed by Ruth Milner and Victor
M. Espinosa, MSc. There were only minor discrepancies between the reanalysis
and the original interpretation of the results and conclusions. When there
was a discrepancy Dr Chanoine included the results from the reanalyses performed
at the British Columbia Children’s Hospital.
Role of the Sponsor: Hoffmann-La Roche was
involved in the study design and conduct and in the analysis and interpretation
of the data. All data were independently reanalyzed by an academic statistician.
The sponsor was permitted to review the manuscript, but the final decision
on content was with the corresponding author in conjunction with the other
Participating Investigators: J. Anderson (University
of Kentucky, Lexington); T. Bravender (Duke Children’s Primary Care,
Durham, NC); L. Cheskin (John Hopkins Bayview Medical Center, Baltimore, Md);
E. Cummings (IWK Grace Health Centre for Children, Women and Families, Halifax,
Nova Scotia); W. Dahms (University Hospitals of Cleveland, Cleveland, Ohio);
H. Dean (Children’s Hospital, Winnipeg, Manitoba); M. A. Drehobl (Scripps
Clinic, San Diego, Calif); K. Ellis (Memorial Family Practice Center, Savannah,
Ga); F. Franklin (Children’s Hospital, Birmingham, Ala); K. Fujioka
(Scripps Clinic, San Diego, Calif); K. Hasan (Phoenix Children’s Hospital,
Phoenix, Ariz); R. Heptulla (Bay State Medical Center, Springfield, Mass);
T. Higgins (Boulder Medical Center, Boulder, Colo); A. G. Hudnut (Sutter Medical
Group Family Practice, Elk Grove, Calif); C. Huot (Hospital St Justine, Montreal,
Quebec); M. S. Jacobson (Schneider Children’s Hospital, New Hyde Park,
NY); G. Kletter (Children’s Hospital and Regional Medical Center, Seattle,
Wash); L. Legault (Montreal Children’s Hospital, Montreal, Quebec);
P. O’Neill (Medical University of South Carolina, Charleston); D. Pacaud
(Alberta Children’s Hospital, Calgary); T. Poling (Heartland Research
Associates, Wichita, Kan); R. Portman (University of Texas—Houston Health
Science Center, Houston); J. Sanchez (Riley Hospital for Children, Indianapolis,
Ind); L. Schnell (Aurora, Ill); D. Smith (CSRA Partners in Health, Augusta,
Ga); J. Spitzer (Kalamazoo, Mich); R. S. Strauss (UMDMJ-Robert Wood Johnson
Medical School, New Brunswick, NJ); S. Travers (Denver, Colo); I. Vargas (New
Acknowledgment: We are grateful to Victor M.
Espinosa, MSc, for his statistical expertise and assistance.