Relationship of Advanced Holding Education and ADherence on Antithrombotic in Younger SPAF Patients
Conditions: Atrial Fibrillation
Sponsor: Boehringer Ingelheim

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Non-Interventional Study
NIS) Protocol
Document Number:
c32188789-01
BI Study Number:

BI Investigational
Product(s):
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Title:
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Brief lay title:
5H$+($'
Protocol version 
identifier:
9HUVLRQ
Date of last version of 
protocol:
1$
PASS:
1R
EU PAS register 
number:
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Active substance:
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Medicinal product:
'DELJDWUDQ
Product reference:
7)'$QXPEHUPJPJPJ
Procedure number:
(0$DJHQF\SURGXFWQXPEHU(0($+&
Marketing authorisation 
holder(s):
7KLVVWXG\LVLQLWLDWHGPDQDJHGDQGILQDQFHGE\
Joint PASS:
1R
Research question and 
objectives:
7KHSULPDU\REMHFWLYHRIWKLVVWXG\LVWRH[SORUHZKHWKHUWKHDGYDQFHG
HGXFDWLRQDOLQWHUYHQWLRQZRXOGLPSURYHWKHDGKHUHQFHWRGDELJDWUDQLQ
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9$6FVFRUHDWEDVHOLQHDQGDWWKHHQGRIWKHVWXG\DQGWRGHVFULEH
VWURNHWKURPERHPEROLFHYHQWVDQGEOHHGLQJHYHQWVLQGDELJDWUDQ

ġBOEHRINGER INGELHEIM Group of Companies
NIS Protocol
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1.
TABLE OF CONTENTS
7,7/(3$*( 
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NIS Protocol
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2.
LIST OF ABBREVIATIONS
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Protocol date:
Study number:
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Version/Revision date:
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Protocol date:
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Protocol date:
Study number:
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Study design:
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Protocol date:
Study number:
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Data sources:
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Study size:
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Data analysis:
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NIS Protocol
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Name 
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Name 
of 
active 
ingredient:
'DELJDWUDQHWH[LODWHPHV\ODWH$7&
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Protocol date:
Study number:
Version/Revision:
Version/Revision date:
2FW
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Milestones:
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5.
AMENDMENTS AND UPDATES
1RQH

ġBOEHRINGER INGELHEIM Group of Companies
NIS Protocol
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6.
MILESTONES
Milestone
Planned Date
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7.
RATIONALE AND BACKGROUND
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ġBOEHRINGER INGELHEIM Group of Companies
NIS Protocol
3DJHRI
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ġBOEHRINGER INGELHEIM Group of Companies
NIS Protocol
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8.
RESEARCH QUESTION AND OBJECTIVES
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9.
RESEARCH METHODS
9.1
STUDY DESIGN
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9.7
DATA ANALYSIS
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9.7.1
Main analysis
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9.7.3
Handling of missing data
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9.8
QUALITY CONTROL
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9.9
LIMITATIONS OF THE RESEARCH METHODS
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9.10
OTHER ASPECTS
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9.10.1
Data quality assurance
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9.10.2
Study records
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STUDY APPROVAL, PATIENT INFORMATION, AND INFORMED 
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MANAGEMENT AND REPORTING OF ADVERSE 
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PUBLISHED REFERENCES
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13.2
UNPUBLISHED REFERENCES
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ANNEX 3. ADDITIONAL INFORMATION
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