Effect of Intensive Treatment of Diabetes on the Development and Progression ofLong-Term Complications in Insulin-Dependent Diabetes Mellitus

摘要

The public document presents the detailed statistical analyses employed in thepreparation of the initial main results article to emanate from the Diabetes Control and Complications Trial published in The New England Journal of Medicine in 1993. The document is organized in three parts. Part I includes a reporting of the manuscript which has been annotated with analysis reference numbers. This also includes an errata section in which a few minor errors are corrected. Part II then presents the detailed analysis plan which specifies the nature of the detailed analyses performed to address each study question. The initial analysis plan was generated by the writing team and the Coordinating Center prior to preparation of the manuscript. Part III then presents the detailed results of statistical analyses used as the basis for the manuscript. Statistical notes which elaborate on the statistical methodology employed are presented at the beginning of this section to clarify the analytic strategies adopted.