Table of Contents
Efficacy of Acamprosate: Clinical Issues
Questions
Overview
What is the Problem with CAD In These Studies?
Pelc-II
Paille
PRAMA
Calculation of CAD: PRAMA
What CAN we make out of the European studies?
Results: Continuous Abstinence
Results: Non-Continuous Abstinence Pelc-II
Results: Non-Continuous Abstinence Paille
Results: Non-Continuous Abstinence PRAMA
Evidence of Efficacy from European Studies
Study US 96.1
Corrected Cumulative Abstinence Duration (% Days Abstinent) Calculation
Results: Intent-to-Treat Population
Potential Explanations
Sponsor-Defined Population “Motivated Efficacy Evaluable”
Reviewer-Defined Populations: Based on pre-randomized variables
Results: % Days Abstinent No Explanation Based on Pre-Randomization Variables
Results: No Explanation in Motivated/Abstinent Subsets
Other Measures
Abstinence From Sustained Heavy Drinking
Other Explorations
Summary
Questions
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