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Evaluation of the WHO HEARTS package to improve control of cardiometabolic risk factors in the primary health care system

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History
# Registration date Revision Id
2 2023-01-16, 1401/10/26 266327
1 2022-12-05, 1401/09/14 247985
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  • Recruitment centers

    #1
    Name of recruitment center - English: Damavand
    Name of recruitment center - Persian: دماوند
    Full name of responsible person - English: Nahid Navaeyan
    Full name of responsible person - Persian: ناهید نوائیان
    Street address - English: Damavand-Gillard - Shahid Fahmideh Alley - next to Dr. Hasabi's Conservatory
    Street address - Persian: دماوند-جیلارد -کوچه شهید فهمیده-جنب هنرستان دکتر حسابی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1985717413
    Phone: +98 21 7631 5677
    Fax:
    Email: ndavood@yahoo.com
    Web page address:
    Name of recruitment center - English: Damavand
    Name of recruitment center - Persian: دماوند
    Full name of responsible person - English: Nahid Navaeyan
    Full name of responsible person - Persian: ناهید نوائیان
    Street address - English: Shahid Fahmideh Ave., Jilard, Damavand.
    Street address - Persian: دماوند، جیلارد، کوچه شهید فهمیده
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1985717413
    Phone: +98 21 7631 5677
    Fax:
    Email: ndavood@yahoo.com
    Web page address:
    #2
    Name of recruitment center - English: Shiraz
    Name of recruitment center - Persian: شیراز
    Full name of responsible person - English: Fariba Moradi Ardakani
    Full name of responsible person - Persian: فریبا مرادی اردکانی
    Street address - English: Shiraz- Shohday Emdadgar St., next to the governorate, Shiraz Shahaday Valfajr Health Center
    Street address - Persian: شیراز- خیابان شهدای امدادگر - جنب فرمانداری - مرکز بهداشت شهدای والفجر شیراز
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7135766563
    Phone: +98 21 5683 7552
    Fax:
    Email: ndavood@yahoo.com
    Web page address:
    Name of recruitment center - English: Shiraz
    Name of recruitment center - Persian: شیراز
    Full name of responsible person - English: Fariba Moradi Ardakani
    Full name of responsible person - Persian: فریبا مرادی اردکانی
    Street address - English: Shahaday Valfajr Health Center, Shohdaye Emdadgar Ave., Shiraz.
    Street address - Persian: شیراز، خیابان شهدای امدادگر، مرکز بهداشت شهدای والفجر شیراز
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7135766563
    Phone: +98 21 5683 7552
    Fax:
    Email: ndavood@yahoo.com
    Web page address:
    #3
    Name of recruitment center - English: Bushehr
    Name of recruitment center - Persian: بوشهر
    Full name of responsible person - English: Razia Hajioni
    Full name of responsible person - Persian: راضیه حاجیونی
    Street address - English: Bushehr, Salh Abad Street, Valfajr Boulevard - Bushehr Health Center
    Street address - Persian: بوشهر ، خ صلح آباد بولوار والفجر - مرکز بهداشت شهرستان بوشهر
    City - English: Bushehr
    City - Persian: بوشهر
    Province: Boushehr
    Country: Iran (Islamic Republic of)
    Postal code: 33500363335
    Phone: +98 77 3332 3548
    Fax:
    Email: ndavood@yahoo.com
    Web page address:
    Name of recruitment center - English: Bushehr
    Name of recruitment center - Persian: بوشهر
    Full name of responsible person - English: Razia Hajioni
    Full name of responsible person - Persian: راضیه حاجیونی
    Street address - English: Bushehr Health Center, Salh Abad Ave., Bushehr
    Street address - Persian: بوشهر ، خیابان صلح آباد، مرکز بهداشت شهرستان بوشهر
    City - English: Bushehr
    City - Persian: بوشهر
    Province: Boushehr
    Country: Iran (Islamic Republic of)
    Postal code: 33500363335
    Phone: +98 77 3332 3548
    Fax:
    Email: ndavood@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Ministry of Health and Medical Education
    Name of organization / entity - Persian: وزارت بهداشت، درمان و آموزش پزشکی
    Full name of responsible person - English: Koorosh Etemad
    Full name of responsible person - Persian: کورش اعتماد
    Street address - English: Tehran, Ministry of Health and Medical Education.
    Street address - Persian: تهران، وزارت بهداشت و درمان و آموزش پزشکی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1467664961
    Phone: +98 21 8145 4357
    Fax:
    Email: leilamolaei_epi@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Ministry of Health and Medical Education
    Name of organization / entity - Persian: وزارت بهداشت، درمان و آموزش پزشکی
    Full name of responsible person - English: Alireza Mahdavi
    Full name of responsible person - Persian: علیرضا مهدوی
    Street address - English: Ministry of Health and Medical Education, Shahrak-Gharb
    Street address - Persian: تهران، شهرک غرب، وزارت بهداشت و درمان و آموزش پزشکی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1467664961
    Phone: +98 21 8145 4357
    Fax:
    Email: armahdavi@yahoo.com
    Web page address:

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Davood Khalili
    Full name of responsible person - Persian: داود خلیلی
    Position - English: Associate Professor
    Position - Persian: دانشیار
    Latest degree: specialist
    Area of specialty/work: 2
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Research Institute for Endocrine Sciences, No. 23, Arabi st., Velenjak
    Street address - Persian: ولنجک، خیابان یمن، خیابان اعرابی، پلاک 23، پژوهشکده غدد درون ریز و متابولیسم
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1985717413
    Phone: 0098021022432500
    Mobile: +98 912 814 8865
    Fax:
    Email: dkhalili@endocrine.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Leila Molaeipour
    Full name of responsible person - Persian: لیلا ملائی پور
    Position - English: Ph.D. Candidate in Epidemiology
    Position - Persian: دانشجوی دکتری اپیدمیولوژی
    Latest degree: master
    Area of specialty/work: 2
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Crossroads of Chamran and Hemmat Expressways, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.
    Street address - Persian: ایران، تهران، تقاطع اتوبان چمران و همت، دانشگاه علوم پزشکی ایران، دانشکده بهداشت.
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1449614535
    Phone: +98 21 2243 2500
    Mobile: +98 912 037 5852
    Fax:
    Email: leilamolaei_epi@yahoo.com
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Davood Khalili
    Full name of responsible person - Persian: داود خلیلی
    Position - English: Associate Professor
    Position - Persian: دانشیار
    Latest degree: specialist
    Area of specialty/work: 2
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Research Institute for Endocrine Sciences, No. 23, Arabi st., Velenjak
    Street address - Persian: ولنجک، خیابان یمن، خیابان اعرابی، پلاک 23، پژوهشکده غدد درون ریز و متابولیسم
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1985717413
    Phone: +98 21 2243 2500
    Mobile: +98 912 814 8865
    Fax:
    Email: dkhalili@endocrine.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Leila Molaeipour
    Full name of responsible person - Persian: لیلا ملائی پور
    Position - English: Ph.D. Candidate in Epidemiology
    Position - Persian: دانشجوی دکتری اپیدمیولوژی
    Latest degree: master
    Area of specialty/work: 2
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Crossroads of Chamran and Hemmat Expressways, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.
    Street address - Persian: ایران، تهران، تقاطع چمران و همت، دانشگاه علوم پزشکی ایران، دانشکده بهداشت.
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1449614535
    Phone: +98 21 2243 2500
    Mobile: +98 912 037 5852
    Fax:
    Email: leilamolaei_epi@yahoo.com
    Web page address:

Protocol summary

Study aim
1- Adaptation and implementation of each of the 6 modules of the HEARTS technical package at the primary health care level. 2- Evaluation of the effectiveness of the implemented package. 3- Determining the effectiveness of interventions on the knowledge, attitude, and practice and health literacy of the studied subjects regarding cardiovascular risk factors, self-care of diabetes, and high blood pressure.
Design
A community-based intervention trial, Two arms parallel group non-randomized trial, in comprehensive health centers
Settings and conduct
This is a community-based study that will be conducted in the following 6 steps: 1. Identifying obstacles and problems 2. Updating Irapen protocols based on the adopted HEARTS package. 3-4. Training and pilot study 5. One-year implementation stage, which will be conducted in comprehensive health centers in Damavand, Shiraz, and Bushehr. In each city, the non-randomly selected centers will be allocated to the intervention and control groups. 6- Evaluating the effectiveness
Participants/Inclusion and exclusion criteria
Eligibility Criteria: Adults aged 30 years or older with a risk of cardiovascular disease/diabetes above 10% or one of the risk factors for diabetes, hypertension, or hyperlipidemia. Exclusion criteria: patients with cardiovascular diseases, pregnant women, patients being treated for an acute illness/medical emergency/patients with an incurable disease.
Intervention groups
Comprehensive health centers in the three cities of Damavand, Shiraz, and Bushehr will be non-randomly assigned to the intervention and control groups. Intervention group: Adopted HEARTS technical package Control group: Current IraPEN program
Main outcome variables
1-Hb A1c 2- Blood Pressure 3. CVD Risk 4- Knowledge, attitude, practice / health literacy

General information

Reason for update
Acronym
IRAN-HEARTS
IRCT registration information
IRCT registration number: IRCT20221126056612N1
Registration date: 2022-12-05, 1401/09/14
Registration timing: prospective

Last update: 2023-05-29, 1402/03/08
Update count: 1
Registration date
2022-12-05, 1401/09/14
Registrant information
Name
Leila Molaeipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5683 7552
Email address
leilamolaei_epi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the WHO HEARTS package to improve control of cardiometabolic risk factors in the primary health care system
Public title
Effectiveness of WHO HEARTS package in prevention and control of diabetes, hypertension, and hyperlipidemia in primary health care
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Adults aged 30 years or above Those with diabetes, hypertension, or hyperlipidemia or those with CVD/Diabetes risk of 10% or above
Exclusion criteria:
History of cardiovascular diseases Pregnancy Acute illness or medical emergency History of an Incurable disease
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 1400
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A community-based intervention trial

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical
Street address
Research Institute for Endocrine Sciences, No.23, Arabi st, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Approval date
2022-11-09, 1401/08/18
Ethics committee reference number
IR.SBMU.ENDOCRINE.REC.1401.084

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

2

Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension

3

Description of health condition studied
Heart Disease
ICD-10 code
I25
ICD-10 code description
Chronic ischemic heart disease

4

Description of health condition studied
Hemorrhage Stroke
ICD-10 code
I60
ICD-10 code description
Nontraumatic subarachnoid hemorrhage

5

Description of health condition studied
Hemorrhage Stroke
ICD-10 code
I61
ICD-10 code description
Nontraumatic intracerebral hemorrhage

6

Description of health condition studied
Ischemic Stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction

Primary outcomes

1

Description
Hb A1c
Timepoint
0,12 months
Method of measurement
Laboratory - enzymatic assay or using point of care

2

Description
Blood Pressure
Timepoint
0, 12 months
Method of measurement
Mercury or digital sphygmomanometer

3

Description
Knowledge attitute and practice / Health literacy
Timepoint
0, 12 months
Method of measurement
Validated questionnaires for Iranian population

4

Description
Patient satisfaction
Timepoint
0 and 12 months
Method of measurement
Validated questionnaires for Iranian population

5

Description
Health System Staff satisfaction
Timepoint
0 and 12 months
Method of measurement
Validated questionnaires for Iranian population

6

Description
Adherence to treatment
Timepoint
0 and 12 months
Method of measurement
Validated questionnaires for Iranian population

7

Description
Fasting plasma glucose
Timepoint
0 and 12 months
Method of measurement
Enzymatic lab measurements or using point of care

8

Description
Total Cholesterol
Timepoint
0 and 12 months
Method of measurement
Enzymatic lab measurements or using point of care

9

Description
Cardiovascular risk score
Timepoint
0 and 12 months
Method of measurement
CVD risk scoring model

10

Description
Diabetes risk score
Timepoint
0 and 12 months
Method of measurement
Diabetes risk scoring model

Secondary outcomes

1

Description
Taking glucose lowering drugs
Timepoint
0 and 12 months
Method of measurement
Checklist

2

Description
Taking blood pressure lowering drugs
Timepoint
0 and 12 months
Method of measurement
Checklist

3

Description
Taking lipid drugs
Timepoint
0 and 12 months
Method of measurement
checklist

Intervention groups

1

Description
Intervention group: Adopted WHO HEARTS technical package. The HEARTS technical package provides a strategic approach to improving cardiovascular health. It comprises six modules and an implementation guide. This package supports Ministries of Health to strengthen CVD management in primary care and aligns with WHO’s Package of Essential Noncommunicable Disease Interventions (WHO PEN). The HEARTS technical package includes the following modules: 1.The Healthy-lifestyle counselling module. This module focuses on the behavioral risk factors and provides information on: tobacco use, unhealthy diet, insufficient physical activity and harmful use of alcohol and also behavioral change, brief interventions for counselling and key points for motivational interviewing. 2. The Evidence-based protocols module uses hypertension and diabetes screening and treatment as an entry point to control cardiovascular risk factors, prevent target organ damage, and reduce premature morbidity and mortality. A comprehensive risk-based approach for integrated management of hypertension, diabetes, and high cholesterol is included in the Risk-based CVD management module. 3.The Access to essential medicines and technology module focuses on access to medicines and basic equipment for CVD management. 4. Risk-based CVD management module helps to identify those who would benefit from lifestyle changes and basic medical treatment to lower blood pressure, cholesterol, and manage diabetes mellitus in an integrated manner. The updated WHO CVD risk prediction charts were developed and presented for 21 global regions to maximize between-region variability and minimize heterogeneity in mortality and major drivers of health outcomes within each region. The charts are intended to allow the introduction of a total risk-stratification approach for management of CVD. They are presented as laboratory-based and non-laboratory-based charts. Laboratory-based algorithms include information on age, sex, smoking status, systolic blood pressure, history or evidence of diabetes mellitus, and the total cholesterol value. In the non-laboratory-based algorithms, body mass index (BMI) is included; information on diabetes mellitus and cholesterol is not necessary for these charts. 5. The Team-based care module uses multidisciplinary teams (which may involve new staff or the shifting of tasks among existing staff). Teams can include patients themselves, primary care physicians, and other allied health professionals, such as nurses, pharmacists, counsellors, social workers, nutritionists, community health workers, or others. Teams reduce the burden on physicians by utilizing the skills of trained health workers. 6. Systems for monitoring module provides a set of indicators on CVD management to allow progress to be monitored. In the current research, initially, the current IraPEN protocols will be adopted based on the HEARTS technical packages by conducting a qualitative study, and then the updated packages will be applied as an intervention in the intervention group. More information is available at: https://www.who.int/publications/i/item/9789240001367
Category
Other

2

Description
Control group: IraPEN programs for cardiometabolic disorders including routin tasks defined for physicians and health-workers in primary health care. In brief, in IraPEN, individuals aged 30 years and older were called for screening of cardiovascular risk factors and calculation of their 10-year CVD risk based on the WHO/ISH risk assessment chart for the Eastern Mediterranean region B, using smoking status, diabetes, systolic blood pressure, total cholesterol and age variables. According to this chart, people were placed in four risk groups as follows:1. Low risk (less than 10%); care, and risk assessment were followed annually. 2. Medium risk (10 to less than 20%); care, and risk assessment were followed every 9 months. 3. High risk (20 to less than 30%), care, and risk assessment were followed every 6 months. 4. Very High risk (30% and above), care, and risk assessment were followed every 3 months. Meanwhile, all individuals with diabetes, pre-diabetes, hypertension, and hypercholesterolemia are detected, educated, controlled and referred to physicians in systematic and scheduled packages. Follow-up and care of patients with hypertension and diabetes are done every month by Behvarz/health care provider and every 3 months by a physician. For patients with hyperlipidemia, pre-diabetes, and obesity, these follow-ups and care are done every 3 months by Behvarz/health care provider and they are referred to a physician if needed. All follow-ups and care are scheduled and registered through the electronic health information systems. More information is available at: https://health.sbmu.ac.ir/index.jsp?pageid=33694&p=1
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Damavand
Full name of responsible person
Nahid Navaeyan
Street address
Shahid Fahmideh Ave., Jilard, Damavand.
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 7631 5677
Email
ndavood@yahoo.com

2

Recruitment center
Name of recruitment center
Shiraz
Full name of responsible person
Fariba Moradi Ardakani
Street address
Shahaday Valfajr Health Center, Shohdaye Emdadgar Ave., Shiraz.
City
Shiraz
Province
Fars
Postal code
7135766563
Phone
+98 21 5683 7552
Email
ndavood@yahoo.com

3

Recruitment center
Name of recruitment center
Bushehr
Full name of responsible person
Razia Hajioni
Street address
Bushehr Health Center, Salh Abad Ave., Bushehr
City
Bushehr
Province
Boushehr
Postal code
33500363335
Phone
+98 77 3332 3548
Email
ndavood@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ministry of Health and Medical Education
Full name of responsible person
Alireza Mahdavi
Street address
Ministry of Health and Medical Education, Shahrak-Gharb
City
Tehran
Province
Tehran
Postal code
1467664961
Phone
+98 21 8145 4357
Email
armahdavi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ministry of Health and Medical Education
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Molaeipour
Position
Ph.D. Candidate in Epidemiology
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Crossroads of Chamran and Hemmat Expressways, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2243 2500
Email
leilamolaei_epi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Davood Khalili
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Epidemiology
Street address
Research Institute for Endocrine Sciences, No. 23, Arabi st., Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2500
Email
dkhalili@endocrine.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Molaeipour
Position
Ph.D. Candidate in Epidemiology
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Crossroads of Chamran and Hemmat Expressways, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2243 2500
Email
leilamolaei_epi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The current research is a community-based study. The extensive data collected in this study is registered in a national health information system and is confidential, and it is not possible to be shared.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The results of this study will be published as a scientific paper.
When the data will become available and for how long
After completing the study
To whom data/document is available
Access to the documents will be with the permission of the Research Institute for Endocrine Sciences of Shahid Beheshti University of Medical Sciences.
Under which criteria data/document could be used
Access to the documents will be with the permission of the Research Institute for Endocrine Sciences of Shahid Beheshti University of Medical Sciences.
From where data/document is obtainable
Research Institute for Endocrine Sciences of Shahid Beheshti University of Medical Sciences
What processes are involved for a request to access data/document
Official letter to the Research Institute for Endocrine Sciences of Shahid Beheshti University of Medical Sciences
Comments
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