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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 ........................................ .................................... Relationship for Combination Relationship for Safety.

CONFIDENTIAL Module 2.5 Clinical Overview 6 ABBREVIATIONS 3TC lamivudine ABC abacavir AE Adverse event AIDS Acquired immunodeficiency syndrome ALT Alanine aminotransferase

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

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