title: Response.
authors.affiliation: Department of Biostatistics, University of Washington, Seattle, WA, USA tfleming@u.washington.edu.
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Fleming
mesh_terms: D026661:Clinical Trials Data Monitoring Committees / Q000458:organization & administration*; D002986:Clinical Trials as Topic / Q000379:methods*; D000068240:Data Anonymization / Q000592:standards*; D005260:Female; D006801:Humans; D008297:Male