Author Contributions: Dr Kaplan 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: Kaplan, Roehrborn, Rovner, Carlsson, Bavendam, Guan.
Acquisition of data: Rovner, Bavendam, Guan.
Analysis and interpretation of data: Kaplan, Roehrborn, Rovner, Carlsson, Bavendam, Guan.
Drafting of the manuscript: Kaplan, Roehrborn, Carlsson, Bavendam, Guan.
Critical revision of the manuscript for important intellectual content: Kaplan, Roehrborn, Rovner, Bavendam, Guan.
Statistical analysis: Roehrborn, Carlsson.
Obtained funding: Bavendam.
Administrative, technical, or material support: Kaplan, Bavendam, Guan.
Study supervision: Kaplan, Roehrborn, Guan.
Financial Disclosures: Mr Carlsson and Drs Bavendam and Guan are employed by Pfizer Inc. Dr Kaplan is a paid consultant, speaker, and meeting participant for Pfizer and is a consultant for Astellas, GlaxoSmithKline, Allergan, and Sanofi. Dr Kaplan is also a speaker for Sanofi Aventis and a principal investigator for the National Institute of Diabetes and Digestive and Kidney Diseases. Dr Roehrborn is a paid consultant, speaker, and meeting participant for Pfizer. Dr Roehrborn is also a consultant for GlaxoSmithKline, Sanofi Aventis, and Lilly ICOS, a consultant for Allergan and Esprit, a speaker for Astellas and Esprit, and a study investigator for Allergan and Q-Med.
Funding/Support: This study was funded by Pfizer Inc.
Role of the Sponsor: Mr Carlsson and Drs Bavendam and Guan were involved in all elements of this study, including, but not limited to, study design and monitoring. In addition, the database containing the findings at all 95 investigator sites was maintained by Pfizer Inc, and statistical analyses were performed at Pfizer Inc by Mr Carlsson. All authors, including those employed by Pfizer Inc, reviewed and edited the manuscript.
Independent Statistical Analysis: All study data were transferred from Pfizer Inc to the Department of Obstetrics and Gynecology at the University of Texas Southwestern Medical Center for independent reanalysis by Donald D. McIntyre, PhD. The independent statistical analysis involved the primary and secondary outcomes, participant demographics, and safety as described in this article. There were no discrepancies between the results of the reanalysis and those presented in the article. Compensation for Dr McIntyre was provided through an unrestricted grant from Weill Medical College. Pfizer did not provide funds to support the independent statistical analysis.
Acknowledgment: We would like to acknowledge the editorial assistance of Melinda Ramsey, PhD, from Complete Healthcare Communications Inc for the preparation of this article. Dr Ramsey provided writing assistance to the authors, and this compensation was provided by Pfizer Inc.