History
# Registration date Revision Id
2 2021-01-31, 1399/11/12 172129
1 2020-12-31, 1399/10/11 165497
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  • Protocol summary

    Determining the effectiveness of the natural product SALIRAVIRA containing of Licorice, Coneflower , Ginseng, Hyssop, Rhubarb and Rosemary extracts as antiviral treatment in COVID-19 patients
    Determining the effectiveness of "SALIRAVIRA" as a natural product containing of Licorice, Coneflower, Ginseng, Hyssop, Rhubarb and Rosemary extracts to coronavirus load in COVID-19 patients
    Two arm parallel group randomized double-blind controlled trial
    Randomized blind controlled trial with two parallel groups
    Patients are recruited in Tehran Heart center and clinic assigned in two parallel groups randomly.Participants and outcome evaluators are blind to the study
    Patients are recruited in the infectious diseases department of Imam Khomeini Hospital complex and a clinic; assigned in two parallel groups randomly.Participants and outcome evaluators are blind to the study
    بیمارگیری در مرکز قلب تهران - گروه عفونی و کلینیک مشخص شده با دو گروه موازی و به صورت تصادفی انجام می شود. شرکت کننده و ارزیابی کننده پیامد نسبت به مطالعه کور هستند
    بیمارگیری در بخش عفونی بیمارستان امام خمینی و کلینیک مشخص شده با دو گروه موازی و به صورت تصادفی انجام می شود. شرکت کننده و ارزیابی کننده پیامد نسبت به مطالعه کور هستند
    Inclusion criteria: Covid-19 infection confirmed by positive PCR-viral load test Some or all of the symptoms include fever, fatigue, muscle aches (headache), headache, cough, chest tightness, and shortness of breath. Exclusion criteria: Malignant tumors and other acute systemic diseases and respiratory problems Life-threatening comorbidity Use of any other herbal substance.Pregnancy Lactation and drug and Alcohol abuse.
    Inclusion criteria: COVID-19 patient confirmed by positive PCR-viral load test, Having some or all of the symptoms include fever, fatigue, muscle aches ( body aches), headache, cough, chest tightness, and shortness of breath. Exclusion criteria: Malignant tumors and other acute systemic diseases and respiratory problems Life-threatening comorbidity, Use of any other herbal substance.Pregnancy, Lactation and drug and Alcohol addiction.
    شرایط ورود: ابتلا به کووید-19 تائیدشده با مثبت شدن PCR-viral load test داشتن برخی و یا همه علائم شامل تب، خستگی، درد عضلانی (بدن درد)، سردرد، سرفه، احساس خفگی در قفسه سینه و تنگی نفس که بنا بر تظاهرات بالینی ابتلا به کرونا ویروس تشخیص داده شده است. شرایط عدم ورود: ابتلا به تومور بدخیم و سایر بیماری های حاد سیستمیک عفونت همزمان و مشکلات تنفسی کوموربیدیتی تهدیدکننده حیات مصرف هر ماده گیاهی دیگر ، بارداری شیردهی ، اعتیاد به مواد مخدر و الکل
    شرایط ورود: ابتلا به کووید-19 تائیدشده با مثبت شدن PCR-viral load test ، داشتن برخی و یا همه علائم شامل تب، خستگی، درد عضلانی (بدن درد)، سردرد، سرفه، احساس خفگی در قفسه سینه و تنگی نفس که بنا بر تظاهرات بالینی ابتلا به کرونا ویروس تشخیص داده شده است. شرایط عدم ورود: ابتلا به تومور بدخیم و سایر بیماری های حاد سیستمیک عفونت همزمان و مشکلات تنفسی کوموربیدیتی تهدیدکننده حیات مصرف هر ماده گیاهی دیگر ، بارداری، شیردهی ، اعتیاد به مواد مخدر و الکل
    Intervention group: Patients who receive herbal product SALIRAVIRA along with standard treatments. Control group: Patients who receive only standard treatments
    Intervention group: Patients who receive "SALIRAVIRA" along with standard treatments as add on therapy. Control group: Patients who receive only standard treatments.
    Virus clearance, Improving the symptoms of the disease such as fever and shortness of breath
    Viral clearance, Improving the symptoms of the disease such as fever and shortness of breath
  • General information

    2
    N/A
    empty
    Addition a site for patient recruitment (Hospital)
    empty
    افزودن یک مرکز بیمارگیری (بیمارستان)
    study of the effectiveness of the natural product SALIRAVIRA on the treatment of COVID-19 patients
    study of the effectiveness of "SALIRAVIRA" as a natural product on the treatment of COVID-19 patients
    Study of the effectiveness of the natural product SALIRAVIRA containing licorice, Cone flower, Ginseng, Hyssop, Rhubarb and Rosemary extracts on the recovery of Covid-19 patients
    Study of the effectiveness of "SALIRAVIRA" as a natural product containing Licorice, Cone flower, Ginseng, Hyssop, Rhubarb and Rosemary extracts on the recovery of COVID-19 patients
    Covid-19 infection clinical confirmed
    Positive PCR-viral load test for COVID-19
    People with a history of contact with COVID-19 infected patients in the last 10 days
    Lung involvement under 20% - Using CT-Scan
    Clinical confirmation of coronavirus infection
    COVID-19 positive test reporting by RT-PCR
    Cases with contact history with a COVID-19 patients in last 10 days
    Lung involvement below 20% - Using CT-Scan
    Pregnancy and Lactation
    Malignant tumors and other acute systemic diseases with special indication
    Patients suffering from autoimmune diseases like psoriasis ,ALS and MS
    Respiratory problems Life-threatening comorbidity
    People addicted to alcohol or drugs
    Use of any other experimental treatment for Covid 19
    Pregnancy and Lactation cases
    Cases with malignant tumors and other acute systemic diseases or special indication
    Patients suffering from autoimmune diseases like Psoriasis, ALS and MS
    Patients with comorbidity of respiratory life-threatening problems
    Addiction to drugs and alcohol
    Participation to another clinical trial for COVID-19
    The participants will be assigned to two groups by block randomization method. In order to minimize the probability of sequence prediction, blocks with variable size (4 and 6) will be used. The randomization ratio will be 1:1. Randomization will be done using Random allocation software.Allocation concealment will be done by assigning unique codes
    The participants will be assigned to two groups by block randomization method. In order to minimize the probability of sequence prediction, blocks with variable (4 and 6) size will be used. The randomization ratio will be 1:1. Randomization will be done using Random allocation software. Allocation concealment will be done by assigning unique codes.
  • Primary outcomes

    #1
    Virus Clearance
    Viral Clearance
    At the beginning of the study and and 4 and 8 days after intake
    At the beginning of the study and and 4, 8 days after intake
  • Intervention groups

    #1
    Intervention group: Patients who receiving herbal product "SALIRAVIRA" containing mentioed extracts orally and as a respiratory spray at the same time with standard treatments: 1- Oral 750 mg SALIRAVIRA tablet containing 500 mg of plant extracts mentioned before; 4 times a day , Once every 6 hours (this pill is packed in blisters contain 10 tablet and will be provided to each patient for the duration of treatment, ie 32 tablet) All process of extraction, production and packaging done under GMP conditions in Mimdaroo pharmaceutical company. 2 - SALIRAVIRA respiratory spray (20ml), which contains plant extracts mentioned before will be used 4 times a day, once every 6 hours, nasally or orally with SALIRAVIRA tablets. SALIRAVIRA spray contains 100mcl of plant extract per puff and its daily dose is 400 mcl based on pharmacopoeia and monographs. All stages of production and packaging of SALIRAVIRA spray have been done under GMP conditions and in Mimdaroo Pharmaceutical company. The duration of treatment will be 8 days.
    Intervention group: Patients who receiving "SALIRAVIRA" containing mentioned extracts orally and respiratory spray at the same time in addition to standard treatments of COVID-19: 1- Oral; SALIRAVIRA tablet 750 mg; containing 500 mg of plant extracts mentioned before; 4 times daily, Once every 6 hours (tablets are packed in blisters contain 10 tablet and will be provided to each case for the duration of treatment, ie 32 tablet) All process of extraction, production and packaging done under GMP conditions in Mimdaroo pharmaceutical company. 2 - SALIRAVIRA respiratory spray (20ml), which contains plant extracts mentioned before will be used 4 times daily, once every 6 hours, spay will be used nasal or throat along with tablets. SALIRAVIRA spray contains 100mcl of plant extract per puff and its daily dose is 400 mcl based on references. All stages of production and packaging of SALIRAVIRA spray have been done under GMP conditions and in Mimdaroo Pharmaceutical company. The duration of treatment will be 8 days.
  • Recruitment centers

    #1
    Name of recruitment center - English: Imam Khomeini Hospital Complex, Department of Infectious Disease
    Name of recruitment center - Persian: مجتمع بیمارستانی امام خمینی، بخش عفونی
    Full name of responsible person - English: Mohammadreza Salehi
    Full name of responsible person - Persian: محمدرضا صالحی
    Street address - English: Gharib St., Keshavarz Blvd. Imam Khomeini Hospital
    Street address - Persian: انتهای بلوار کشاورز، خیابان غریب، بیمارستان امام خمینی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1419733141
    Phone: +98 66 9390 0121
    Fax:
    Email: SALEHI.MOHAMAD3@GMAIL.COM
    Web page address:
  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Tahereh Hosseinabadi
    Full name of responsible person - Persian: طاهره حسین آبادی
    Position - English: Associate professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 41
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No.2660 Vali-asr Ave., Tehran . IRAN
    Street address - Persian: خیابان ولیعصر ، پلاک 2660
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1996835113
    Phone: +98 21 8820 0118
    Mobile: +98 912 426 3831
    Fax: +98 21 8866 5250
    Email: hosseinabadi.t@gmail.com
    Web page address: http://pharmacy.sbmu.ac.ir/index.jsp?pageid=32628&p=1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Tahereh Hosseinabadi
    Full name of responsible person - Persian: طاهره حسین آبادی
    Position - English: Associate professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 41
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No.2660, Vali-asr Ave.
    Street address - Persian: خیابان ولیعصر ، پلاک 2660
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1996835113
    Phone: +98 21 8820 0118
    Mobile: +98 912 426 3831
    Fax: +98 21 8866 5250
    Email: hosseinabadi.t@gmail.com
    Web page address: http://pharmacy.sbmu.ac.ir/index.jsp?pageid=32628&p=1
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Mimdaroo Pharmaceutical Co.
    Name of organization / entity - Persian: شرکت داروسازی میم دارو
    Full name of responsible person - English: Fatemeh Azadinia
    Full name of responsible person - Persian: فاطمه آزادی نیا
    Position - English: Consultant
    Position - Persian: مشاور
    Latest degree: bachelor
    Area of specialty/work: 88
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No. 04, 4th alley, Ghanbarzadeh St. Shahid Beheshti St., Tehran, Iran
    Street address - Persian: خیابان شهید بهشتی-خیابان قنبرزاده- بالاتر از خیابان خرمشهر- خیابان چهارم - شماره ۴
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1533853613
    Phone: +98 21 9662 1410
    Mobile: +98 912 579 3791
    Fax: +98 21 9662 1410
    Email: Saleh.rkh@gmail.com
    Web page address: https://www.mimdaroo.com/
    contact.organization_id:
    Name of organization / entity - English: Mimdaroo Pharmaceutical Co.
    Name of organization / entity - Persian: شرکت داروسازی میم دارو
    Full name of responsible person - English: Fatemeh Azadinia
    Full name of responsible person - Persian: فاطمه آزادی نیا
    Position - English: Consultant
    Position - Persian: مشاور
    Latest degree: bachelor
    Area of specialty/work: 88
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No. 4, 4th alley, Ghanbarzadeh St. Shahid Beheshti St., Tehran, Iran
    Street address - Persian: خیابان شهید بهشتی-خیابان قنبرزاده- بالاتر از خیابان خرمشهر- خیابان چهارم - شماره ۴
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1533853613
    Phone: +98 21 9662 1410
    Mobile: +98 912 579 3791
    Fax: +98 21 9662 1410
    Email: Saleh.rkh@gmail.com
    Web page address: https://www.mimdaroo.com/
  • Sharing plan

    1- The applicant would be asked to provide a written formal request letter, containing the importance of the data . 2- Following the receipt of request letter, the data would be provided in no more than one week.
    1- The applicant would be asked to provide a written formal request letter, containing the importance of the data . 2- Following the receipt of request letter, the data would be provided in no more than one week.
    1- از متقاضی درخواست خواهد شد تا دلیل درخواست اطلاعات را ذکر نماید 2-پس از دریافت درخواست کتبی از وی، حداکثر پس از یک هفته اطلاعات در اختیار وی قرار خواهد گرفت.
    1- از متقاضی درخواست خواهد شد تا دلیل درخواست اطلاعات را ذکر نماید 2-پس از دریافت درخواست کتبی از وی، حداکثر پس از یک هفته اطلاعات در اختیار وی قرار خواهد گرفت.

Protocol summary

Study aim
Determining the effectiveness of "SALIRAVIRA" as a natural product containing of Licorice, Coneflower, Ginseng, Hyssop, Rhubarb and Rosemary extracts to coronavirus load in COVID-19 patients
Design
Randomized blind controlled trial with two parallel groups
Settings and conduct
Patients are recruited in the infectious diseases department of Imam Khomeini Hospital complex and a clinic; assigned in two parallel groups randomly.Participants and outcome evaluators are blind to the study
Participants/Inclusion and exclusion criteria
Inclusion criteria: COVID-19 patient confirmed by positive PCR-viral load test, Having some or all of the symptoms include fever, fatigue, muscle aches ( body aches), headache, cough, chest tightness, and shortness of breath. Exclusion criteria: Malignant tumors and other acute systemic diseases and respiratory problems Life-threatening comorbidity, Use of any other herbal substance.Pregnancy, Lactation and drug and Alcohol addiction.
Intervention groups
Intervention group: Patients who receive "SALIRAVIRA" along with standard treatments as add on therapy. Control group: Patients who receive only standard treatments.
Main outcome variables
Viral clearance, Improving the symptoms of the disease such as fever and shortness of breath

General information

Reason for update
Addition a site for patient recruitment (Hospital)
Acronym
IRCT registration information
IRCT registration number: IRCT20201220049771N1
Registration date: 2020-12-31, 1399/10/11
Registration timing: registered_while_recruiting

Last update: 2021-02-21, 1399/12/03
Update count: 1
Registration date
2020-12-31, 1399/10/11
Registrant information
Name
Tahereh Hosseinabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0118
Email address
hosseinabadi.t@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-03-15, 1399/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effectiveness of "SALIRAVIRA" as a natural product containing Licorice, Cone flower, Ginseng, Hyssop, Rhubarb and Rosemary extracts on the recovery of COVID-19 patients
Public title
study of the effectiveness of "SALIRAVIRA" as a natural product on the treatment of COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical confirmation of coronavirus infection COVID-19 positive test reporting by RT-PCR Cases with contact history with a COVID-19 patients in last 10 days Lung involvement below 20% - Using CT-Scan
Exclusion criteria:
Pregnancy and Lactation cases Cases with malignant tumors and other acute systemic diseases or special indication Patients suffering from autoimmune diseases like Psoriasis, ALS and MS Patients with comorbidity of respiratory life-threatening problems Addiction to drugs and alcohol Participation to another clinical trial for COVID-19
Age
From 12 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be assigned to two groups by block randomization method. In order to minimize the probability of sequence prediction, blocks with variable (4 and 6) size will be used. The randomization ratio will be 1:1. Randomization will be done using Random allocation software. Allocation concealment will be done by assigning unique codes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of School of Pharmacy and Nursing & Midwifery - Shahid Beheshti University of Medic
Street address
NO 2660, Vali-asr Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1996835113
Approval date
2020-12-13, 1399/09/23
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1399.276

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19 virus identified

Primary outcomes

1

Description
Viral Clearance
Timepoint
At the beginning of the study and and 4, 8 days after intake
Method of measurement
Polymerase chain reaction (PCR)

2

Description
Fever and symptoms
Timepoint
At the beginning of the study and daily during treatment after intake
Method of measurement
Using a thermometer and clinical diagnosis

3

Description
shortness of breath
Timepoint
At the beginning of the study and daily during treatment after intake
Method of measurement
Medical diagnosis

Secondary outcomes

1

Description
olfactory (sense of smell)
Timepoint
At the beginning of the study and daily during treatment after intake
Method of measurement
Questionnaire with interview

2

Description
sense of taste
Timepoint
At the beginning of the study and daily during treatment after intake
Method of measurement
Questionnaire with interview

Intervention groups

1

Description
Intervention group: Patients who receiving "SALIRAVIRA" containing mentioned extracts orally and respiratory spray at the same time in addition to standard treatments of COVID-19: 1- Oral; SALIRAVIRA tablet 750 mg; containing 500 mg of plant extracts mentioned before; 4 times daily, Once every 6 hours (tablets are packed in blisters contain 10 tablet and will be provided to each case for the duration of treatment, ie 32 tablet) All process of extraction, production and packaging done under GMP conditions in Mimdaroo pharmaceutical company. 2 - SALIRAVIRA respiratory spray (20ml), which contains plant extracts mentioned before will be used 4 times daily, once every 6 hours, spay will be used nasal or throat along with tablets. SALIRAVIRA spray contains 100mcl of plant extract per puff and its daily dose is 400 mcl based on references. All stages of production and packaging of SALIRAVIRA spray have been done under GMP conditions and in Mimdaroo Pharmaceutical company. The duration of treatment will be 8 days.
Category
Treatment - Drugs

2

Description
Control group: Patients receiving standard treatments for COVID-19 disease for 8 days. Standard treatment is determined according to the protocols and guidelines of the Ministry of Health and is performed in all centers.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Heart Center- infectious disease Dept.
Full name of responsible person
Naser Mohammadi
Street address
North Kargar-Ave
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Email
nasmoh@gmail.com

2

Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex, Department of Infectious Disease
Full name of responsible person
Mohammadreza Salehi
Street address
Gharib St., Keshavarz Blvd. Imam Khomeini Hospital
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 66 9390 0121
Email
SALEHI.MOHAMAD3@GMAIL.COM

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tahereh Hosseinabadi
Street address
No.2660, Vali-e-asr Ave.,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0118
Fax
+98 21 8866 5250
Email
hosseinabadi.t@gmail.com
Web page address
http://pharmacy.sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
MimDaroo Pharmaceutical Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
MimDaroo Pharmaceutical Co.
Full name of responsible person
Saleh Ramezani Khorshiddoust
Position
Member of Board
Latest degree
Master
Other areas of specialty/work
Medical Pharmacy
Street address
No. 04, 4th alley, Ghanbarzadeh St. Shahid Beheshti St., Tehran, Iran
City
tehran
Province
Tehran
Postal code
1533853613
Phone
+98 21 9662 1410
Email
Saleh.rkh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tahereh Hosseinabadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.2660, Vali-asr Ave.
City
tehran
Province
Tehran
Postal code
1996835113
Phone
+98 21 8820 0118
Fax
+98 21 8866 5250
Email
hosseinabadi.t@gmail.com
Web page address
http://pharmacy.sbmu.ac.ir/index.jsp?pageid=32628&p=1

Person responsible for updating data

Contact
Name of organization / entity
Mimdaroo Pharmaceutical Co.
Full name of responsible person
Fatemeh Azadinia
Position
Consultant
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No. 4, 4th alley, Ghanbarzadeh St. Shahid Beheshti St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1533853613
Phone
+98 21 9662 1410
Fax
+98 21 9662 1410
Email
Saleh.rkh@gmail.com
Web page address
https://www.mimdaroo.com/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Data can be shared after de-identification
When the data will become available and for how long
Data will be available from April, 2030
To whom data/document is available
Academics employed at various research/university institutions and the industry.
Under which criteria data/document could be used
Using the de-identified data will be allow for scientific research by academics, including faculty members and students. In this case, by sending the request and reviewing it, the requested data will be provided.
From where data/document is obtainable
At first should refer to a person responsible for general inquiries of the clinical trial and then to the principal investigator.
What processes are involved for a request to access data/document
1- The applicant would be asked to provide a written formal request letter, containing the importance of the data . 2- Following the receipt of request letter, the data would be provided in no more than one week.
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