Pivotal European Efficacy StudiesDefinitions of Common Outcome Parameters

• Time to first drink

  • The number of days from the start of double-blind study medication to the estimated day of first consumption of any alcohol.

• Rate of complete abstinence

  • Percent of patients completing the study without consuming any alcohol (relative to number of patients treated).

• Cumulative Abstinence Duration, %

  • Estimated percent of abstinent time on study

Source: ISE Section 8.7.1.2.5

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