Published Online: November 5, 2012. doi:10.1001/jama.2012.25790
Author Contributions: Drs Sullivan and Stein had full access to all 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: Sullivan, Olsson, Scott, Kim, Wasserman, Stein.
Acquisition of data: Sullivan, Olsson, Stein.
Analysis and interpretation of data: Sullivan, Olsson, Scott, Kim, Xue, Gebski, Wasserman, Stein.
Drafting of the manuscript: Sullivan, Olsson, Stein.
Critical revision of the manuscript for important intellectual content: Sullivan, Olsson, Scott, Kim, Xue, Wasserman, Stein.
Statistical analysis: Xue, Gebski.
Obtained funding: Scott, Wasserman.
Administrative, technical, or material support: Xue.
Study supervision: Scott, Kim, Wasserman.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Sullivan reported having received research funding from Amgen, Abbott Products, AstraZeneca, Merck Sharp and Dohme, and sanofi-aventis and also having received funding for educational programs from Abbott Products, AstraZeneca, Merck Sharp and Dohme, Pfizer Australia, and Roche and travel support from Merck Sharp and Dohme. Dr Sullivan reported having served on advisory boards for Abbott Products, Merck Sharp and Dohme, and Pfizer Australia. Dr Olsson reported having received research support from Amgen, AstraZeneca, Karobio, Merck Sharp and Dohme, Pfizer, Roche, and sanofi-aventis and consultation fees from AstraZeneca, Karobio, Merck, Pfizer, and Roche. Mr Gebski is employed by the NHMRC Clinical Trials Centre, University of Sydney, which received compensation from Amgen for statistical analysis. Dr Stein reported having received consulting fees from Amgen, Adnexus Therapeutics, and sanofi related to PCSK9 inhibitors, and his institution has received research funding related to PCSK9 clinical trials from Amgen, sanofi, and Regeneron. Drs Scott, Kim, Xue, and Wasserman are employees of Amgen and have received Amgen stock/stock options.
Funding/Support: This trial was funded by Amgen.
Role of Sponsor: The sponsor led, participated in, and funded the design and conduct of the study in collaboration with the academic authors. The sponsor funded and participated in the collection and management of data. The sponsor also funded the independent analysis of data and participated with the investigators in the interpretation of the data. All authors, including those employed by the sponsor, participated in the preparation and review of the manuscript, with editorial assistance provided by the sponsor. All authors, including those employed by the sponsor, provided approval of the manuscript.
Independent Statistical Analysis: The data were independently analyzed and validated using complete raw data sets by Val Gebski, MStat, of National Health and Medical Research Council Clinical Trials Centre, University of Sydney, who received remuneration from the sponsor for this work. The results of the independent statistical analysis are the results reported in this article.
Additional Contributions: Editorial support was provided by Meera Kodukulla, PhD, of Amgen and Sue Hudson, BA, PRO Unlimited, Bethpage, New York, who was compensated by Amgen. Statistical support and programming were provided by Thomas Liu, PhD; Wei Cui, MS; and Ying Xiang, MS, of Amgen. Beat Knusel, PhD, of Amgen, developed the study protocol. Clinical study management was provided by Moetaz Albizem, MD; Celeste Love, MPA; and Akbar Jaffer, MSc, of Amgen. Nathan Koon, BA, and Patrick McElligott, BSc, of Amgen provided data management support. The Amgen employees were not compensated for their contributions besides their salaries. A list of GAUSS study participating centers and principal investigators appears
in eAppendix 2.