Real World Evidence (RWE) of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Poland (HCV RWE PMOS)
Conditions: Chronic Hepatitis C
Sponsor: AbbVie

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1.0......................................................................................... Table of Contents 2 
2.0 
Abbreviations ................................................................................................. 4 
3.0 
Responsible Parties ........................................................................................ 7 
4.0 
Abstract .......................................................................................................... 8 
5.0 
Amendments and Updates ........................................................................... 12 
6.0 
Milestones ..................................................................................................... 13 
7.0 
Rationale and Background .......................................................................... 13 
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Research Question and Objectives .............................................................. 20 
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Research Methods ........................................................................................ 21 
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10.0 
Protection of Human Subjects ..................................................................... 39 
11.0 
Management and Reporting of Complaints 
11.1                      Medical Complaints ..................................................................................... 40 
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12.0 
Plans for Disseminating and Communicating Study Results ...................... 44 
13.0 
References .................................................................................................... 45 
Annex 1. 
EQ5D-5L ...................................................................................................... 50 
Annex 2. 
WPAI ............................................................................................................ 51 
 
Annex 3. 
Child-Pugh Classification of Severity of Cirrhosis...................................... 54 
14.0 
Protocol Signature Page............................................................................... 59 

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