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Module 2.5 Clinical Overview

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CONFIDENTIALModule Clinical Overview1Module OverviewCopyright 2012ViiV Healthcare and the GlaxoSmithKline group of companies. All rights reserved. Unauthorizedcopying or use of this information is Clinical Overview2TABLE OF PRODUCT DEVELOPMENT Therapies and its Unmet Clinical Indication and Development with Good Clinical Practice (GCP)................................... ........132. Overview OF Overview OF , Distribution, Metabolism and Elimination of and in Healthy Subjects and Target Patient of Dolutegravir PK in Special with Hepatitis B or of Dolutegravir on thePharmacokinetics of Other of Other Agents on the Pharmacokinetics of Dolutegravir and Dose of DTG on Cardiac of DTG on Renal Pharmacodynamic Relationships and Definition of No Effect Boundaries.

CONFIDENTIAL Module 2.5 Clinical Overview 7 EVG elvitegravir FC Fold change FDA (US) Food and Drug Administration FDC Fixed dose combination FPV fosamprenavir

  Clinical, Overview, Module 2, Module, 5 clinical overview

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