Published Online: May 18, 2014. doi:10.1001/jama.2014.5217.
Study concept and design: McEvoy, Gonzales, Durand, Frei, Peters, Morris, Spindel.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: McEvoy, Peters, Spindel.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: McEvoy, Peters, Spindel.
Obtained funding: McEvoy, Peters, Morris, Spindel.
Administrative, technical, or material support: McEvoy, Spindel.
Study supervision: McEvoy, Spindel.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Gonzales reported receiving research contracts from Pfizer and owning 5 shares of Pfizer stock. No other authors reported disclosures.
Funding/Support: This work was supported by National Heart, Lung, and Blood Institute (NHLBI) grant K23 HL080231 with co-funding from ODS; NHLBI grant HL087710; NHLBI grant HL105447; UL1 RR024140 01; P51 OD011092; Medical Research Foundation of Oregon.
Role of the Sponsors: The funding organizations had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; the preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication.
Additional Contributions: We are indebted to the members for their unpaid roles on our data and safety monitoring board: Linda Wallen, MD (University of Washington); Kirk Lalawani, MD (Oregon Health & Science University); and Thuan Nguyen, PhD (Oregon Health & Science University). None of these persons received any compensation for their contributions. We also thank all of the women and children who participated in this study.