Author Contributions: Dr Thadhani, Ms Wenger, and Dr Chang 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: Thadhani, Applebaum, Pritchett, Chang, Tamez, Manning, Solomon.
Acquisition of data: Thadhani, Applebaum, Chang, Wenger, Manning, Solomon.
Analysis and interpretation of data: Thadhani, Applebaum, Pritchett, Chang, Wenger, Tamez, Bhan, Agarwal, Zoccali, Wanner, Lloyd-Jones, Cannata, Thompson, Andress, Zhang, Packham, Singh, Zehnder, Shah, Pachika, Manning, Solomon.
Drafting of the manuscript: Thadhani, Chang, Wenger, Tamez, Solomon.
Critical revision of the manuscript for important intellectual content: Thadhani, Applebaum, Pritchett, Chang, Wenger, Tamez, Bhan, Agarwal, Zoccali, Wanner, Lloyd-Jones, Cannata, Thompson, Andress, Zhang, Packham, Singh, Zehnder, Shah, Pachika, Manning, Solomon.
Statistical analysis: Thadhani, Pritchett, Chang, Wenger, Zhang.
Obtained funding: Thadhani.
Administrative, technical, or material support: Thadhani, Chang, Wenger.
Study supervision: Thadhani, Applebaum, Pritchett, Chang, Tamez, Bhan, Agarwal, Zoccali, Wanner, Lloyd-Jones, Cannata, Thompson, Andress, Zhang, Packham, Singh, Zehnder, Shah, Pachika, Manning, Solomon.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Thadhani reported receiving a coordinating grant from Abbott Laboratories to the Massachusetts General Hospital and speaker's fees and travel support from Abbott Laboratories. Drs Pritchett, Andress, and Zhang are employees of Abbott Laboratories and may own Abbott stock or options. Dr Agarwal reported receiving honoraria for serving on the speaker's bureau and steering committees of Abbott Laboratories. Dr Zoccali reported receiving consulting/honorarium fees and travel support from Abbott Laboratories, honoraria for lectures from Genzyme, Roche, Amgen, Abbott Laboratories, and Malesci and research grants from Pfizer, Roche, and Abbott Laboratories. Drs Wanner and Packham serve on an advisory board and have received travel support from Abbott Laboratories. Dr Wanner has received research support and speakers fees from Abbott Laboratories. Dr Zehnder reported receiving honoraria for serving on a steering committee and for lectures from Abbott Laboratories and receiving grants from Abbott Laboratories. Dr Manning received travel support for a CMR meeting from Abbott Laboratories. Dr Solomon is supported by a research grant from Abbott Laboratories to the Brigham and Women's Hospital. No other disclosures were reported.
PRIMO Investigators: Australia: Stephen McDonald, Grahame Elder, Michael Suranyi, Rosemary Masterson, Ian Fraser, David Packham; Czech Republic: Vladimir Tesar, Ondrej Viklicky; Germany: Frank Dellanna, Stefan Degenhardt, Kai Hahn, Martin Nitschke, Christoph Wanner; Italy: Francesco Pugliese and Vincenzo Panichi; Poland: Michal Nowicki; Puerto Rico: Rafael Burgos-Calderon, Jose Cangiano, Angel Comulada-Rivera, Maria Rios, Jose Vazquez-Tanus; Romania: Mihai Voiculescu; Russia: Valentin Ermolenko, Natalia Tamilina, Galina Volgina; Spain: Angel Luis Martin de Francisco, Luis Miguel Ruilope, Maria Jose Soler; Taiwan: Yung-Ming Chen, Hung-Hsiang Liou, Shin-Hung Tsai, Chun-Chen Yu; United Kingdom: Daniel Zehnder; United States: Lionel Abbott, Hanna Abboud, Ali Assefi, Mario Belledonne, Marializa Bernardo, Geoffrey Block, David Burstein, Gabriel Contreras, George Fadda, Seth Goldberg, Mandeep Grewal, Terry Hammond, Nelson Kopyt, Richard Lund, Peter McCullough, William Moore, Joseph Muhlestein, Kaldun Nossuli, Anita Patel, German Ramirez, Amit Sharma, Bhupinder Singh, Nicole Stankus, Samir Tuma, Thomas Wiegmann.
Funding/Support: This study was funded by an investigator-initiated grant from Abbott Laboratories.
Role of the Sponsor: This was an investigator-initiated study that was funded by industry (Abbott Laboratories) and led by a steering committee composed of academic members, 2 sponsor members (nonvoting), and statisticians. The steering committee oversaw the design, conduct, and all analyses. Data were collected by the sponsor and shared with the principal investigator at the study mid point and termination. Final assignment code was sent to the principal investigator after the database lock. The principal investigator, with statisticians at Massachusetts General Hospital, independently performed all prespecified and exploratory analyses and resolved any discrepancies with industry statisticians. The sponsor provided the active medication and matching placebo. The principal investigator wrote the first draft of the manuscript and the steering committee was responsible for data interpretation and manuscript completion. The sponsor reviewed the manuscript, but decisions about the final manuscript were made by the principal investigator and academic members of the steering committee. All authors vouch for the integrity of the data.
Independent Statistical Analysis: The principal investigator, Dr Thadhani, with Ms Wenger and Dr Chang, statisticians at Massachusetts General Hospital, independently performed all prespecified and exploratory analyses and resolved any discrepancies with industry statisticians. The results of the independent analyses are the results that are reported in the article.
Additional Contributions: We thank Anne Kavanaugh, Stacey Orzel, MBA, MT(ASCP), and Keith Boardway, Abbott Laboratories, for their organizational support of the PRIMO trial, and we thank all participants. We also thank members of the data and safety monitoring committee: Theodore Steinman, MD (chair), Beth Israel Deaconess Medical Center; Mark Sarnak, MD, MS, Tufts Medical Center; and Sheryl F. Kelsey, PhD, University of Pittsburgh. All members of the data and safety monitoring committee received compensation for their role in the study. Finally, we thank Dalane Kitzman, MD, Wake Forest Baptist Medical Center, for his critical review of the manuscript.