A Prospective Observational Program Using Digital Technology Tools to Enhance Patient Adherence to Omacor Therapy
Conditions: History of Myocardial Infarction, Hypertriglyceridemia
Sponsor: Abbott

 
 
Protocol  ID PUFA5004 
 
 
 
MEAF.10.01.T01                    This information is confidential to Abbott  
 
 
Page 1 of 16 
1.0 
Title Page 
Post Marketing Observational Study 
PROTOCOL  
Amendment 1 
(Protocol ID PUFA5004) 
 
A PROSPECTIVE OBSERVATIONAL PROGRAM USING DIGITAL 
TECHNOLOGY TOOLS TO ENHANCE PATIENT ADHERENCE TO 
OMACOR THERAPY (DIAPAsOn) 
 
Product Name: 
Omacor (Omega-3 triglycerides [EPA/DHA=1.2/1 - 90%]) 
Type of Study: 
Observational 
Date of the Protocol: 
August 21, 2017 
Date of the Amendment 1: 12th February 2018 
Sponsor 
Abbott Laboratories 
125171, Moscow 
Russian Federation, 
Leningradskoe shosse, 16А, 
bld. 1, 
Metropolis Business Center 
Tel.: + 7 495 258 4280 
Fax: +7 495 258 4281 
 
 
 
 
 
 
This study will be conducted in compliance with this protocol. 
Confidential Information 
No use or disclosure outside Abbott is permitted without prior written authorization from Abbott. 

 
 
Protocol  ID PUFA5004 
 
 
 
 
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                               Page 2 of 16 
2.0 
Table of Contents 
1.0 
TITLE PAGE .................................................................................. 1 
2.0 
TABLE OF CONTENTS ................................................................... 2 
3.0 
REASON FOR AMENDMENT .......................................................... 2 
4.0 
CHANGES ...................................................................................... 2 
 
 
3.0 
Reason for amendment 
 
Discrepancy between Protocol inclusion criteria and routine clinical practice.  
 
The Investigators informed that it’s impossible to match inclusion criteria that patient 
should have been taking Omacor for at least 3 days at the time of enrollment into the program 
(inclusion criteria #3) because patients usually return to the physician not earlier than 1 month 
after treatment administration.    
 
4.0 
Changes 
 The changes were made in the inclusion criteria #3 and corrected throughout the Protocol. 
The changes were summarized in the table below:  
Section, 
page 
Previous version 
New version 
6.1.1 
Inclusion 
Criteria, page 
8 
3. Patients having been prescribed 
Omacor 
(Omega-3 
triglycerides 
[EPA/DHA = 1.2/1 - 90%]) for at least 
6 months 
AND 
who have been taking Omacor for 10±7 
days at the time of enrollment into the 
program. 
3. Patients having been prescribed Omacor 
(Omega-3 triglycerides [EPA/DHA = 1.2/1 
- 90%]) for at least 6 months 
AND 
who have been taking Omacor no more 
than 14 days at the time of enrollment into 
the program. 
6.5 
Study 
Conduct, 
Figure 1. The 
program 
flow-chart, 
page 12 
Patients who have been receiving 
Omacor for 10 ± 7 days 
Patients who have been receiving 
Omacor no more than 14 days 

 
 
Protocol  ID PUFA5004 
 
 
 
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Page 3 of 16 
1.0 
Title Page 
Post Marketing Observational Study 
PROTOCOL  
(Protocol ID PUFA5004) 
 
A PROSPECTIVE OBSERVATIONAL PROGRAM USING DIGITAL 
TECHNOLOGY TOOLS TO ENHANCE PATIENT ADHERENCE TO 
OMACOR THERAPY (DIAPAsOn) 
 
Product Name: 
Omacor (Omega-3 triglycerides [EPA/DHA=1.2/1 - 90%]) 
Type of Study: 
Observational 
Date: 
August 21, 2017 
Sponsor 
Abbott Laboratories 
125171, Moscow 
Russian Federation, 
Leningradskoe shosse, 16А, 
bld. 1, 
Metropolis Business Center 
Tel.: + 7 495 258 4280 
Fax: +7 495 258 4281 
 
 
 
 
 
 
 
This study will be conducted in compliance with this protocol. 
Confidential Information 
No use or disclosure outside Abbott is permitted without prior written authorization from Abbott. 

 
 
Protocol  ID PUFA5004 
 
 
 
 
MEAF.10.01.T01                    This information is confidential to Abbott 
                               Page 4 of 16 
2.0 
Table of Contents 
1.0 
TITLE PAGE .................................................................................. 1 
2.0 
TABLE OF CONTENTS ................................................................... 2 
3.0 
REASON FOR AMENDMENT .......................................................... 2 
4.0 
CHANGES ...................................................................................... 2 
1.0 
TITLE PAGE .................................................................................. 3 
2.0 
TABLE OF CONTENTS ................................................................... 4 
3.0 
RATIONALE .................................................................................. 5 
4.0 
STUDY OBJECTIVE(S) ................................................................... 5 
4.1.1 
Inclusion Criteria .................................................................................................. 7 
4.1.2 
Exclusion Criteria ................................................................................................. 7 
4.2 
Number of Patients to be Enrolled ........................................................................ 8 
4.3 
Study Duration ...................................................................................................... 8 
4.3.1 
Product Supply ...................................................................................................... 8 
4.3.2 
Description of Activities ....................................................................................... 8 
5.0 
PHARMACOVIGILANCE-RELEVANT INFORMATION .................... 9 
5.1 
Definitions............................................................................................................. 9 
5.1.1 
Adverse Drug Reaction (ADR) ............................................................................. 9 
5.1.2 
Other Pharmacovigilance- relevant information ................................................... 10 
5.2 
Serious AE/ADR Collection Period...................................................................... 10 
5.3 
Reports on ADR, SADR and other safety-related data......................................... 11 
6.0 
ETHICS AND QUALITY……………………………………………………..11 
7.0 
DATA ANALYSIS PLANS…………………………………………………...12 
8.0 
FINAL REPORT AND PUBLICATIONS…………………………………...15 
9.0 
REFERENCES………………………………………………………………...16 

 
 
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Page 5 of 16 
3.0 
Rationale 
 This study is a prospective observational program within the frames of which Omacor 
(Omega-3 triglycerides [EPA/DHA = 1.2/1 - 90%]) is prescribed to patients with a history of 
myocardial infarction within a routine procedure as a part of the combination therapy (in 
combination with statins, antiaggregants, beta-blockers, angiotensin-converting enzyme 
inhibitors (ACE)) and/or to patients with hypertriglyceridemia. The population of observed 
patients will be limited to those who were prescribed Omacor for the first time or not earlier than 
3 months after the last dose of Omacor and course of administration is at least 6 months. 
 
This program is conducted to assess the effectiveness of the use of digital technology tools 
to enhance the adherence of patients with a history of myocardial infarction and/or 
hypertriglyceridemia, as well as to assess the impact of the use of digital technology tools on the 
effectiveness of treatment and improvement of the quality of life of these patients.  
 
The primary objective of the program is to assess patient adherence to therapy with 
Omacor. Adherence is defined as the extent to which a person's behavior in taking medication 
corresponds with agreed recommendations from a health care provider (World Health 
Organization, 2003) that expects patient active involvement into treatment process and strong 
relationship between patient and physician. In this study adherence rate will be calculated as the 
sum of days when patient taken the full prescribed dose of Omacor in period divided by the number 
of days in period. 
 
Secondary objectives include assessment of the reasons for discontinuation of Omacor, 
assessment of the quality of patients’ life and assessment of health outcome during the study. 
 
Additional tasks of the program include a description of the target patient population 
prescribed with Omacor, as well as raising patients’ awareness about the disease. 
4.0 
Study Objective(s) 
Primary objective 
1. 
To assess adherence to therapy with Omacor in post-MI patients or patients with 
hypertriglyceridemia. 
Secondary objectives 
1. 
To evaluate the reasons for the termination of therapy with Omacor. 
2. 
To evaluate the quality of life of patients during the program. 
3. 
To evaluate health outcomes in patients group during the program. 

 
 
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Primary endpoints 
1. 
Mean adherence rate at the end of the study (Visit 3).  
Adherence rate will be calculated as the sum of days when patient taken the full prescribed 
dose of Omacor® in period divided by the number of days in period.  
2. 
Mean score of National questionnaire of treatment compliance (edited by Fofanova T.V. 
et al.) [9] at the end of the study (Visit 3).  
Secondary endpoints 
1. 
The percentage of patients who have chosen each of the suggested reasons for therapy 
termination. 
2. 
The average score on each of 8 scales of SF-36 quality of life questionnaire at Visit 2 and 
Visit 3 vs. the baseline (Visit 1).  
3. 
Change of lipid profile parameters at Visit 2 and Visit 3 vs. the baseline (Visit 1). 
4. 
Number of hospitalizations due to cardio-vascular reasons during 6 months of the program. 
5. 
Number of new cases of stenocardia during 6 months of the program. 
6. 
Number of non-fatal myocardial infarction cases during 6 months of the program. 
7. 
Number of cases of cardio-vascular death during 6 months of the program.  
8. 
Mean adherence rate at Visit 2. 
9. 
Change of mean adherence rate by end of the study (Visit 3) versus Visit 2.  
10. 
The percentage of patients with adherence rate <0,5, 0,5-0,7, ≥0,8 at Visit 2 and Visit 3.  
11. 
Mean score of National questionnaire of treatment compliance (edited by Fofanova T.V. 
et al.) [9] at Visit 1, Visit 2.  
12. 
Change of mean score of National questionnaire of treatment compliance (edited by 
Fofanova T.V. et al.) [9] at Visit 2 and Visit 3 versus baseline (Visit 1). 
Experimental endpoints 
 
1. 
The average number of days when Omacor was taken during observational study period 
of 6 months. The last day of drug product administration is defined as date of last Omacor 
dose or last subject visit within this program whatever is earlier.  
2. 
Correlation between primary endpoints and patients’ social characteristics (gender, age, 
employment status, education level, marital status).  
3. 
The percentage of patients who assess the drug product usability as very good, good, 
moderate and poor after 1 month of Omacor treatment. 

 
 
Protocol  ID PUFA5004 
 
 
 
 
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                               Page 7 of 16 
 
For endpoints which are applicable, further analysis will be performed in subgroups of 
patients with the different medication adherence rate: <0,5, 0,5-0,7, ≥0,8 at Visit 2 and Visit 3. 
Adherence rate will be calculated as the sum of days when patient taken the full prescribed dose 
of Omacor in period divided by the number of days in period.  
 
Additional objectives of the program include a description of the target patient population 
prescribed with Omacor, as well as raising patients’ awareness about the disease. 
4.1.1 
Inclusion Criteria 
1. 
Men and women ≥ 18 years of age. 
2. 
Patients with history of myocardial infarction not earlier than 6 months ago. 
 
AND/OR 
 
Patients with diagnosis of hypertriglyceridemia. 
3. Patients having been prescribed  Omacor (Omega-3 triglycerides [EPA/DHA = 1.2/1 - 
90%]) for at least 6 months  
AND  
who have been taking Omacor for 10±7 days at the time of enrollment into the program. 
4. 
Patients who can, in the opinion of the Investigator, himself or through immediate 
relatives’s help complete electronic system of data collection through mobile application 
or web-browser.  
5. 
Patients who have signed the consent to participate in this program before entering their 
data in the eCRF and who understand their right to discontinue  the program at any time. 
 
4.1.2 
Exclusion Criteria 
1. Patients taken medicines (except for Omacor) or nutrition supplements containing omega-
3 in any proportions at the time of enrollment into the program  
OR  
it has been less than 3 months since last dose of medicines or nutrition supplements 
containing omega-3 taken. 
2. Female patients during pregnancy or breastfeeding. 
3. Patients with increased sensitivity to the active substance, excipients, and soy. 
4. Patients with exogenous hypertriglyceridemia (type I hyperchylomicronemia). 

 
 
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                               Page 8 of 16 
5. Participation in any other clinical or non-clinical study/program at present or within the 
latest 30 days. 
6. Patients with any other clinical states that make him/her ineligible for the program on the 
study doctor’s opinion based on clinical assessment. 
 
4.2 
Number of Patients to be Enrolled 
 
In total, the program will include 3000 patients from approximately 150-200 sites (300 
physicians) in the Russian Federation. The number of patients enrolled by each physician/site will 
be limited in order to avoid a situation when 1 large site affects results, thus having a negative 
impact on the representativeness.  
4.3 
Study Duration 
 
The observation period will last from the enrollment in the program during Visit 1 until 
Visit 3 (Month 6 ±30 days). Discontinuation of the drug product administration by the patient 
is not the reason for exclusion of the patient from the study.  
 
A decision on the duration of treatment is made by the attending physician at his/her 
discretion in accordance with the valid approved Instruction and the routine clinical practice but 
this program will include patients who are prescribed Omacor for at least 6 months. It is expected 
that the enrollment period will be approximately 3 months. The overall duration of the program is 
about 9 months. 
4.3.1 
Product Supply 
 
Since this is a non-interventional observational program and the drug product is prescribed 
within the frames of a routine clinical practice, Abbott does not provide Omacor. The treatment 
should be prescribed in accordance with the current Instruction for Medical Use and local 
recommendations. 
4.3.2 
Description of Activities 
 
After enrollment in the program, patients will visit the study site once again to assess their 
state approximately 3 months and 6 months later. Some of these data will be entered by the patients 
themselves using their personal account in the electronic system of the program. 

 
 
Protocol  ID PUFA5004 
 
 
 
 
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5.0 
Pharmacovigilance-Relevant Information 
5.1 
Definitions 
5.1.1 
Adverse Drug Reaction (ADR) 
 
The adverse drug reaction (ADR) is defined as a response to a medicinal product which 
is noxious and unintended. In this context, the response means that a causal relationship between 
the drug product and the adverse event is, at least, rationally possible. Adverse drug reactions may 
occur as a result of the drug product administration both within the frames of the officially 
registered Instruction or in the case of the off-label use, or as a result of exposure at the workplace. 
Cases of the off-label use include administration of the drug product for unregistered indications, 
overdose, misuse, abuse, and medication errors. 
 
If an adverse drug reaction meets any of the following criteria, it is considered a serious 
adverse drug reaction (SADR): 
Patient’s death - an adverse reaction that leads to patient’s death. 
Life threatening reaction is an adverse reaction that would lead to the immediate death, on 
investigator’s opinion, if a medical intervention has not been made. This does not include 
events which would have been fatal in a more severe form. 
Hospitalization - an adverse reaction that led to admission to the hospital for any period of 
time. This does not include visits to the emergency departments or outpatient’s clinic. 
Prolongation of hospitalization - an adverse reaction that occurs in a study subject during 
the hospitalization and prolongs the patient’s stay in the hospital. 
Congenital abnormality/malformation - an abnormality identified at birth or after it, or any 
defect that leads to the fetal loss. 
Persistent or significant disability/incapacity - an adverse reaction that leads to a condition 
which significantly interferes with daily activities of a program participant. 
Important medical event requiring medical or surgical intervention to prevent serious 
outcome is an important from a medical point of view adverse event that at first may not be life-
threatening or result in death or hospitalization, but, on the basis of a medical conclusion, it may 
endanger the patient and require medical or surgical intervention to prevent any of the outcomes 
listed above (for example, the death of the subject, threat to his/her life, hospitalization, 
prolongation of hospitalization, congenital abnormality/malformation or persistent or significant 
disability/incapacity). Examples of such events include allergic bronchospasm requiring an 

 
 
Protocol  ID PUFA5004 
 
 
 
 
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                               Page 10 of 16 
intensive care in the emergency unit or domiciliary, abnormal changes in the blood or convulsions 
that do not result in hospitalization or the development of drug addiction or drug abuse. 
5.1.2 
Other Pharmacovigilance- relevant information 
In the context of this Protocol, “other safety-related data” means: 
− cases related to the exposure of the drug product during pregnancy (related to the mother, the 
father or the fetus) with the development of an adverse drug reaction or without it; 
− transmammary exposure of the drug product on the infant (transmission through the breast 
milk) with the development of an adverse drug reaction or without it; 
− overdose with the development of an adverse drug reactions or without it; 
− abuse or misuse (for example, use without clinical reasons) with the development of an 
adverse drug reaction or without it; 
− medication errors (for example, any event that may cause or lead to inappropriate use of the 
drug product or harm a patient, despite the fact that the treatment is monitored by a healthcare 
professional, patient, or consumer) with the development of an adverse drug reaction or 
without it; 
− unexpected therapeutic or clinical benefit of the drug product administration; 
− any failure in the expected pharmacological effect (for example, “reports on the lack of 
efficacy”); 
− supposed transfer of the infectious agent through the drug product; 
− off-label use with the development of an adverse drug reaction or without it; 
unintentional, accidental exposure or exposure at the workplace with the development of an 
adverse drug reaction or without it. 
5.2 
Serious AE/ADR Collection Period 
 
Adverse drug reactions, serious adverse drug reactions and other safety-related 
information will be reported to Abbott from the inclusion of the patient in the program during 
Visit 1 until Visit 3. All adverse reactions, observed in a patient outside the frames of this program 
should be reported to regulatory authorities by a physician in accordance with the legislation of 
the Russian Federation and the local practice of the healthcare institution.  
 

 
 
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                               Page 11 of 16 
5.3 
Reports on ADR, SADR and other safety-related data 
 
In the case of an adverse drug reaction, serious adverse drug reaction and reporting of other 
safety-related data, a physician must notify the contact person in Abbott mentioned below within 
24 hours after getting acquainted with this information. 
 
 
6.0 
Ethics and Quality 
 
Patient’s written consent to the use and/or disclosure of personal and/or medical 
information must be obtained before his/her inclusion in the program and patients who are not yet 
ready to express such written consent will not be included in the program. However, all reasonable 
efforts will be made to avoid the disclosure of personal information (such as name, address, etc.). 
 
The program will be carried out in accordance with the Protocol, principles of the 
International Conference on Harmonization, ethical standards based on the Declaration of 
Helsinki, and all applicable local requirements. 
 
As it is known, the main purpose of the observational/noninterventional studies is to obtain 
information about everyday clinical practice which is not subjected to any external influences. 
Since it is not always possible to distinguish between “clinical practice” and “intervention”, for 
example, there is still no clear understanding whether the use of questionnaires and patient diaries 
violates the principle of non-intervention, then the final decision is made by the Ethics Committee 
[8]. 
 
Taking into account the facts mentioned above, the Protocol and relevant documents 
related to the program will be submitted to the Ministry of Healthcare of the Russian Federation 
to make a decision to determine the type of study applied in this program; it will also decide 
whether the requirements of the Russian legislation listed in the Federal law No. 61 “On Drug 
Circulation” dd April 12, 2010 may be applied to this program. 
 
Program documents will also be submitted to the Independent Ethics Committee (IEC), 
Intercollegiate Ethics Committee (119002 Moscow, Gagarinsky lane, 37), and, when necessary, 
to the Local Ethics Committees (LEC) in the study sites. Enrollment of patients will begin only 
after receiving a written approval from the IEC. 
 
All data will be collected and processed in a manner that does not disclose the identity of 
individual patients and, therefore, patient confidentiality will be maintained at any time. 

 
 
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                               Page 12 of 16 
 
The study doctor will be responsible for ensuring that the quality control and quality 
control system which ensure the implementation of the program and collection, documentation 
and reporting in accordance with the Protocol, accepted standards of Good Clinical Practice (GCP) 
and all applicable local laws and requirements are implemented. 
 
Members of the clinical research team in the Russian branch of Abbott will monitor 
completeness and correctness of data in electronic CRFs after they have been completed in the 
EDC. Any discrepancy/contradiction will be brought to the attention of the study site in order to 
be corrected. All necessary corrections will be entered to the database in accordance with the 
applicable procedures of the EDC. 
7.0 
Data Analysis Plans 
 
This section describes the basic information about statistical data analysis within the 
frames of this observational program. 
General principles 
 
Since this is an open-label non-randomized non-interventional observational program, 
methods of descriptive summary statistics will primarily be applied. Quantitative variables are 
represented as the number of patients, the mean, standard deviation, median, 1st and 3rd quartile, 
the minimum and maximum values. Qualitative variables are presented in the form of the number 
and percentage of patients in each category. In addition, for the estimated parameters, bilateral 
95% confidence intervals will be calculated. Statistical significance will be calculated for all 
variables. Plots may be made for a visual representation of the findings, if necessary. 
Calculation of a sample size 
 
The main objective of the program is a research and does not aim at verification of any 
hypothesis, so no formal sample size calculation has been carried out. It is planned to include 3000 
patients in 150-200 centers (300 physicians): this sample size is sufficient for adequate scientific 
assessment of findings. 
Population for data analysis 
Per Protocol Population will include those patients who have completed at least Visit 2. This 
population will be used to assess the effectiveness. If the patient discontinues the treatment, the 
follow-up continues until expiration of 6 months from the date of initiation of Omacor. And for 
such patients the level of compliance is also calculated. 

 
 
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                               Page 13 of 16 
 
The endpoints which are applicable will be evaluated in subgroups of patients with the 
different medication adherence rate: <0,5, 0,5-0,7, ≥0,8 at Visit 2 and Visit 3. Adherence rate will 
be calculated as the sum of days when patient taken the full prescribed dose of Omacor in period 
divided by the number of days in period. 
Safety Population will include those patients who have completed at least 1 Visit, i.e. they have 
been taking Omacor for not less than 3 days. This population will be used for reporting on ADR, 
SADR, and other safety-related data. 
Analysis of the primary endpoint 
1. 
Mean adherence rate will be determined at the end of the study (Visit 3). Adherence rate 
will be calculated as the sum of days when patient taken the full prescribed dose of 
Omacor® in period divided by the number of days in period. 
2. 
Mean score of National questionnaire of treatment compliance (edited by Fofanova T.V. 
et al.) [9] will be determined at the end of the study (Visit 3). 
 
Summary of demographics and baseline characteristics 
 
Demographic and baseline characteristics will be summarized by methods of descriptive 
summary statistics described above, and are presented for populations of all patients included in 
the study. 
 
Data on the cardiological anamnesis will be presented in the form of the number and 
percentage of patients in each MedDRA system-organ class (SOC) and preferred terms (PT). 
Secondary endpoints 
1. 
The percentage of patients who have chosen each of the suggested reasons for therapy 
termination will be determined. 
2. 
The average score on each of 8 scales of SF-36 quality of life questionnaire at Visit 2 and 
Visit 3 vs. the baseline (Visit 1) will be determined. 
3. 
The average values of lipid profile at Visit 2 and Visit 3 vs. the baseline (Visit 1) will be 
determined.  
4. 
Number of hospitalizations due to cardio-vascular reasons during 6 months of the program 
will be determined. 
5. 
Number of new cases of stenocardia within 6 months of the program will be determined. 

 
 
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                               Page 14 of 16 
6. 
Number of cases non-fatal myocardial infarction cases during 6 months of the program 
will be determined. 
7. 
Number of cases of cardio-vascular death within 6 months of the program will be 
determined.  
8. 
Mean adherence rate will be determined at Visit 2. Adherence rate will be calculated as the 
sum of days when patient taken the full prescribed dose of Omacor® in period divided by 
the number of days in period.  
9. 
Change of mean adherence rate by end of the study (Visit 3) versus Visit 2 will be 
determined.  
10. 
The percentage of patients with adherence rate <0,5, 0,5-0,7, ≥0,8 will be determined at 
Visit 2 and Visit 3.  
11. 
Mean score of National questionnaire of treatment compliance (edited by Fofanova T.V. 
et al.) [9] will be determined at Visit 1, Visit 2.  
12. 
Change of mean score of National questionnaire of treatment compliance (edited by 
Fofanova T.V. et al.) [9] at Visit 2 and Visit 3 versus baseline (Visit 1) will be determined. 
Experimental endpoints 
 
1. 
The average number of days when Omacor was taken during observational study period of 
6 months will be determined. The last day of drug product administration is defined as date 
of last Omacor dose or last subject visit within this program whatever is earlier.  
2. 
Correlation between primary endpoints and patients’ social characteristics (gender, age, 
employment status, education level, marital status) will be determined.  
3. 
The percentage of patients who assess the drug product usability as very good, good, 
moderate and poor will be determined after 1 month of Omacor treatment. 
 
For endpoints which are applicable, further analysis will be performed in subgroups of 
patients with the different medication adherence rate: <0,5, 0,5-0,7, ≥0,8 at Visit 2 and Visit 3. 
Adherence rate will be calculated as the sum of days when patient taken the full prescribed dose 
of Omacor in period divided by the number of days in period.  
 
Additional objectives of the program include a description of the target patient population 
prescribed with Omacor in addition to the standard therapy, as well as raising patients’ awareness 
about the disease. 

 
 
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                               Page 15 of 16 
General Definitions and Abbreviations 
Since this is an open, non-randomized non-interventional observational program, the meth-
ods of descriptive summary statistics will primarily be used. Quantitative variables will be 
presented as number of patients (N), mean (Mean), standard deviation (SD), median (Median), 1st 
quartile, 3rd quartile, minimum (Min) and maximum values (Max). Qualitative variables will be 
presented in terms of the number and rate of patients in each category and two-sided 95% 
confidence intervals will be calculated. Statistical significance (p-value) will be calculated for all 
comparisons (Visit 2 – Visit 1, Visit 3 – Visit 1). No formal conclusions can be drawn from these 
comparisons as no hypotheses were defined upfront to be tested. If necessary, charts can be 
prepared for the visual presentation of the results. 
Individual patient lists (listings) will be formed for raw data processing. 
 
Analysis of data on ADR, SADR and other safety-related data 
 
All data on ADR, SADR and other safety-related data will be reported separately for each 
patient, i.e. patients will be counted, but not the reactions. It means that if a patient has the same 
reaction repeatedly, the reaction will be counted only once. Repeated reactions in one patient will 
be summarized in accordance with the following rule: if a patient has experienced the same 
reaction more than once, this reaction will receive the highest degree of severity, the most close 
relationship with the drug product and the earliest onset date. 
 
All data on ADR, SADR and other safety-related data will be summarized and evaluated 
regardless of whether they have been reported in accordance with the Protocol or received from 
spontaneous reports. 
8.0 
Final Report and Publications 
 
The final report will be written upon completion of the program. This report will contain 
a description of the program objectives, the methodology of the program and its results and 
conclusions. Completed eCRFs and the report on the program should be treated as a confidential 
property of Abbott Laboratories and may not be transferred to third parties in any form 
(publications or presentations) without obtaining the written approval of Abbott Laboratories. The 
results of this program can be published by Abbott Laboratories or any of the participating 
investigators after receiving a written approval from Abbott Laboratories. 

 
 
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9.0 
References 
1. 
Ageev F.T., Fofanova T.V., Smirnova M.D. Guidelines. Methods of evaluating, 
monitoring and improving patient adherence. Moscow, 2013. (In Russian) 
2. 
Simpson SH, Eurich DT, Majumdar SR, Padwal RS., Tsuyuki RT., Varney J, JohnsonJ 
A.A meta-analysis of the association between adherence to drug therapy and mortality. 
BMJ  2006; 333:15-20 
3. 
Pignone M, Phillips C, Mulrow C. Use of lipid lowering drugs for primary prevention of 
coronary heart disease: meta-analysis of randomized trials. BMJ 2000; 321:983-6 
4. 
Ross SD, Allen IE, Connelly JE et al. Clinical outcomes in statin treatment  trials: a meta-
analysis. Arch Intern Med 1999; 159:1793-802. 
5. 
Turnbull F. Blood Pressure Lowering Treatment Trialists’ Collaboration. Effects of 
different blood-pressure-lowering regimes on major cardiovascular events: results of 
prospectively-designed overviews of randomized trials. Lancet 2003; 362:1527-35 
6. 
Sever PS, Dahlof B, Poulter NR et al. Prevention of coronary and stroke events with 
atorvastatin in hypertensive patients who have average or lower-than-average cholesterol 
concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm 
(ASCOT-LLA): a multicentre randomized controlled trial. Lancet 2003;361:1149-58 
7. 
Clinical recommendations. Congestive heart failure (CHF). 2016 Revision (approved 
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