Assessment of the Oxygen Use and Future Outcomes Associated With Oxygen Use in Patient With Fibrotic ILD
Conditions: Lung Diseases, Interstitial
Sponsor: Boehringer Ingelheim

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Observational and Non-Interventional Study (ONIS) using 
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Document Number:
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BI Investigational
Product(s):
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Title:
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identifier:
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 2 of 40
Study number: <1199-0541>
Document number: <insert>
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 3 of 40
Study number: <1199-0541>
Document number: <insert>

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Date:
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Page 1 of 40
Proprietary confidential information
© 2024 Boehringer Ingelheim Group of companies. All rights reserved.
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 4 of 40
Study number: <1199-0541>
Document number: <insert>
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TABLE OF CONTENTS
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 5 of 40
Study number: <1199-0541>
Document number: <insert>
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 6 of 40
Study number: <1199-0541>
Document number: <insert>
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1.
LIST OF ABBREVIATIONS
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 7 of 40
Study number: <1199-0541>
Document number: <insert>
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%,94'BB$'
2.
RESPONSIBLE PARTIES

BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 8 of 40
Study number: <1199-0541>
Document number: <insert>

%,94'BB$'
2.1.1
ABSTRACT
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 9 of 40
Study number: <1199-0541>
Document number: <insert>

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Protocol date:
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 12 of 40
Study number: <1199-0541>
Document number: <insert>
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 13 of 40
Study number: <1199-0541>
Document number: <insert>
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 16 of 40
Study number: <1199-0541>
Document number: <insert>
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 17 of 40
Study number: <1199-0541>
Document number: <insert>
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 18 of 40
Study number: <1199-0541>
Document number: <insert>
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 19 of 40
Study number: <1199-0541>
Document number: <insert>
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 21 of 40
Study number: <1199-0541>
Document number: <insert>
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Figure 2. Observation and Identification Periods: Aim 2

BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 22 of 40
Study number: <1199-0541>
Document number: <insert>
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 23 of 40
Study number: <1199-0541>
Document number: <insert>
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 25 of 40
Study number: <1199-0541>
Document number: <insert>
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Aim 1 Outcomes
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 26 of 40
Study number: <1199-0541>
Document number: <insert>
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 27 of 40
Study number: <1199-0541>
Document number: <insert>
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%,94'BB$'
7.3.5
Baseline Covariates (Aim 1, Aim 2, and Further Aim)
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 29 of 40
Study number: <1199-0541>
Document number: <insert>
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 30 of 40
Study number: <1199-0541>
Document number: <insert>
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%,94'BB$'
7.4
DATA SOURCES
Figure 3. Optum Data Ecosystem
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 32 of 40
Study number: <1199-0541>
Document number: <insert>
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%,94'BB$'
7.6.1
Aim 1 Analysis
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 33 of 40
Study number: <1199-0541>
Document number: <insert>
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 34 of 40
Study number: <1199-0541>
Document number: <insert>
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 35 of 40
Study number: <1199-0541>
Document number: <insert>
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 36 of 40
Study number: <1199-0541>
Document number: <insert>
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 37 of 40
Study number: <1199-0541>
Document number: <insert>
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PROTECTION OF HUMAN SUBJECTS
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PLANS FOR DISSEMINATING AND COMMUNICATING 
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BOEHRINGER INGELHEIM Group of Companies
ONIS using Existing Data Protocol
Page 38 of 40
Study number: <1199-0541>
Document number: <insert>
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BOEHRINGER INGELHEIM Group of Companies
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Page 40 of 40
Study number: <1199-0541>
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