Table of Contents
Analysis of U.S.A. Multicenter Trial Results
PPT Slide
Objectives of the U.S.A. Multicenter Trial
Objectives of the U.S.A. Multicenter Trial (continued)
Approach to Understanding Efficacy in the U.S.A. Trial
Pivotal European and U.S.A. Study Methods
Drinking Data Collection Methods in Pivotal European and U.S.A. Trials
One Standard Drink Equals 12 Grams of Pure Alcohol
Drinking Data Collection Methods in Pivotal European and U.S.A. Trials (continued)
Drinking Data Obtained in Pivotal European and U.S.A. Trials
Timeline Follow Back Method
U.S.A. Multicenter Study Schema
Manual-Guided Brief Intervention and Medication Compliance Procedures
Acamprosate U.S.A. Multicenter Trial 21 Investigational Sites
Acamprosate U.S.A. Multicenter Trial Patient Characteristics
Acamprosate U.S.A. Multicenter Trial Baseline Clinical Characteristics
Acamprosate U.S.A. Multicenter Trial Baseline Abstinence Parameters
Acamprosate U.S.A. Multicenter Trial Lifetime Baseline Substance Use
Acamprosate U.S.A. Multicenter Trial Baseline Consumption of Cigarettes and Marijuana
Acamprosate U.S.A. Multicenter Trial Patient Disposition and Treatment Participation - Safety Population
U.S.A. Primary Efficacy Results (ITT Population) for Originally Planned Analyses
Baseline Factors Reliably Associated with Alcoholism Treatment Outcome
Baseline Factors Reliably Associated with Alcoholism Treatment Outcome (continued)
Acamprosate U.S.A. Multicenter Trial Covariates Applied Uniformly Across Outcome Measures
Acamprosate U.S.A. Multicenter Trial Case Report Form Question for Treatment Goal
U.S.A. Trial Patient Subgroups
Cumulative Abstinence Duration (%) with Covariates
Cumulative Abstinence Duration (%) with Covariates Treatment + Follow-up Phase
Odds Ratios with Covariates of Good Response (CAD ? 90%) and Poor Response (CAD ? 10%)
Odds Ratios with Covariates of Complete Abstinence During the Last Visit (Treatment Phase) Interval [LOCF]
Percent Reduction (Relative to Baseline) in Drinks per Week on Study with Covariates
Change from Baseline GGT at Treatment Phase Endpoint
Acamprosate U.S.A. Multicenter Trial Overall Summary
Acamprosate U.S.A. Multicenter Trial Overall Summary
Conclusions from Acamprosate U.S.A. and European Pivotal Trials
Conclusions from Acamprosate U.S.A. and European Pivotal Trials
Conclusions from Acamprosate U.S.A. and European Pivotal Trials
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