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The effect of Zinc on Hyperbilirubinemia of healthy and normal newborns, a clinical trial

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History
# Registration date Revision Id
3 2018-09-27, 1397/07/05 70616
2 2018-09-26, 1397/07/04 61211
1 2017-10-14, 1396/07/22 14984
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  • Protocol summary

    Objective: to evaluate the effect of Zinc on Hyperbilirubinemia in newborn babies in Zanjan. Design: randomized selection, double blind, control group of healthy children admitted to the neonatal ward Inclusion criteria: term infants; breast-feeding; jaundice; photo-therapy; serum bilirubin 15-20 mg / dL; age of 3 to 7 days; using no other drug. Exclusion criteria: recent weight loss; infection; hemolytic disease; oral intolerance; congenital birth defects; gastrointestinal anomalies; parental dissatisfaction for participation in the study; need for ventilators; need for blood transfusion. Population studied: three to seven days old babies with Hyperbilirubinemia admitted to the neonatal ward of Ayatollah Mousavi Hospital in Zanjan. Sample size: 112 people Case study: prescribing Zinc and placebo syrup with a similar amount in three days in the case group and control group and measuring serum bilirubin in every three days. Time of intervention: no restrictions Outcome: reducing the serum bilirubin faster than past time.
    empty
    هدف: بررسی تأثیر روی بر هایپربیلیروبینمی نوزادان تازه متولد شده شهر زنجان طراحی: انتخاب تصادفی، دوسو کور، گروه کنترل از کودکان سالم بستری در در بخش نوزادان معیارهای ورود: نوزادان ترم؛ شیرمادر خوار؛ مبتلا به زردی؛ تحت درمان فتوتراپی؛ بیلی روبین سرم 15 الی 20 میلی گرم بر دسی لیتر؛ سن 3 الی 7 روز؛ عدم مصرف داروی دیگر معیارهای خروج: کاهش وزن اخیر؛ عفونت؛ بیماری همولیتیک؛ عدم تحمل خوراکی؛ بیماریهای مادرزادی که مانع خوردن نوزاد میشوند؛ آنومالیهای دستگاه گوارش؛ عدم رضایت والدین برای شرکت در مطالعه؛ نیاز به ونتیلاتور؛ نیاز به تعویض خون جمعیت مورد مطالعه: نوزادان 7-3 روزه دارای هایپربیلیروبینمی بستری در بخش نوزادان بیمارستان آیت الله موسوی زنجان حجم نمونه: 112 نفر مداخله مورد مطالعه: دریافت شربت زینک و پلاسبو با مقدار تعیین شده طی سه روز به گروه های کیس و کنترل و اندازه گیری بیلیروبین خون در هر سه روز زمان مداخله: محدودیتی ندارد پیامد:کاهش سریع تر بیلیروبین خون
    empty
    empty
    Evaluate the effect of Zinc on Hyperbilirubinemia in newborn babies in Zanjan
    empty
    بررسی تأثیر روی بر هایپربیلیروبینمی نوزادان تازه متولد شده شهر زنجان
    empty
    Randomized selection, double blind, control group of healthy children admitted to the neonatal ward
    empty
    انتخاب تصادفی، دوسو کور، گروه کنترل از کودکان سالم بستری در در بخش نوزادان
    empty
    Place: Ayatollah Mousavi Hospital in Zanjan Blinded people: Participant, Care provider
    empty
    محل انجام: بیمارستان آیت اله موسوی زنجان افراد کورسازی شده: شرکت کننده، ارائه دهنده خدمت
    empty
    Inclusion criteria: term infants; breast-feeding; jaundice; photo-therapy; serum bilirubin 15-20 mg / dL; age of 3 to 7 days; using no other drug. Exclusion criteria: recent weight loss; infection; hemolytic disease; oral intolerance; congenital birth defects; gastrointestinal anomalies; parental dissatisfaction for participation in the study; need for ventilators; need for blood transfusion
    empty
    معیارهای ورود: نوزادان ترم؛ شیرمادر خوار؛ مبتلا به زردی؛ تحت درمان فتوتراپی؛ بیلی روبین سرم 15 الی 20 میلی گرم بر دسی لیتر؛ سن 3 الی 7 روز؛ عدم مصرف داروی دیگر معیارهای خروج: کاهش وزن اخیر؛ عفونت؛ بیماری همولیتیک؛ عدم تحمل خوراکی؛ بیماریهای مادرزادی که مانع خوردن نوزاد میشوند؛ آنومالیهای دستگاه گوارش؛ عدم رضایت والدین برای شرکت در مطالعه؛ نیاز به ونتیلاتور؛ نیاز به تعویض خون
    empty
    Population studied: three to seven days old babies with Hyperbilirubinemia admitted to the neonatal ward of Ayatollah Mousavi Hospital in Zanjan. Sample size: 112 people Case study: prescribing Zinc and placebo syrup with a similar amount in three days in the case group and control group and measuring serum bilirubin in every three days. Time of intervention: no restrictions
    empty
    جمعیت مورد مطالعه: نوزادان 7-3 روزه دارای هایپربیلیروبینمی بستری در بخش نوزادان بیمارستان آیت الله موسوی زنجان حجم نمونه: 112 نفر مداخله مورد مطالعه: دریافت شربت زینک و پلاسبو با مقدار تعیین شده طی سه روز به گروه های کیس و کنترل و اندازه گیری بیلیروبین خون در هر سه روز زمان مداخله: محدودیتی ندارد
    empty
    Total bilirubin of serum levels, duration of photo-therapy
    empty
    سطح سرمی بیلیروبین توتال، مدت فتوتراپی

  • General information

    1
    1
    Term infants
    Breast-feeding
    Jaundice
    Photo-therapy
    Serum bilirubin 15-20 mg/dL
    Age 3 to 7 days
    Using no other drug
    نوزادان ترم
    شیرمادر خوار
    مبتلا به زردی
    تحت درمان فتوتراپی
    بیلی روبین سرم 15 الی 20 میلی گرم بر دسی لیتر
    سن 3 الی 7 روز
    عدم مصرف داروی دیگر
    recent weight loss
    infection
    hemolytic disease
    oral intolerance
    congenital birth defects
    gastrointestinal anomalies
    parental dissatisfaction for participation in the study
    need for ventilators
    need for blood transfusion
    کاهش وزن اخیر
    عفونت
    بیماری همولیتیک
    عدم تحمل خوراکی
    بیماریهای مادرزادی که مانع خوردن نوزاد میشوند
    آنومالیهای دستگاه گوارش
    عدم رضایت والدین برای شرکت در مطالعه
    نیاز به ونتیلاتور
    نیاز به تعویض خون
    empty
    Block randomization
    empty
    تصادفی سازی بلوک
    empty
    Blinded people: Participant, Care provider
    empty
    افراد کورسازی شده: شرکت کننده، ارائه کننده خدمت

  • Recruitment centers

    #1
    Name of recruitment center - English: Ayatollah Mousavi Hospital
    Name of recruitment center - Persian: بیمارستان آیت الله موسوی
    Full name of responsible person - English: Dr. Parisa Khoshnevis Asl
    Full name of responsible person - Persian: دکتر پریسا خوشنویس اصل
    Street address - English: Ayatollah Mousavi Hospital, Gavazang street, Zanjan, Iran
    Street address - Persian: ایران، زنجان، خیابان گاوازنگ، بیمارستان آیت الله موسوی
    City - English: Zanjan
    City - Persian: زنجان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Ayatollah Mousavi Hospital
    Name of recruitment center - Persian: بیمارستان آیت الله موسوی
    Full name of responsible person - English: Dr. Parisa Khoshnevis Asl
    Full name of responsible person - Persian: دکتر پریسا خوشنویس اصل
    Street address - English: Ayatollah Mousavi Hospital, Gavazang street, Zanjan, Iran
    Street address - Persian: ایران، زنجان، خیابان گاوازنگ، بیمارستان آیت الله موسوی
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Country: Iran (Islamic Republic of)
    Postal code: 4515613191
    Phone: +98 24 3315 6319
    Fax:
    Email: international@zums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Chancellor of Research and Technology, Zanjan University of Medical Sciences (Primary sponsor)
    Name of organization / entity - Persian: معاونت تحقیقات و فناوری دانشگاه علوم پزشکی زنجان
    Full name of responsible person - English: Dr. Alireza Shoghli
    Full name of responsible person - Persian: دکتر علیرضا شغلی
    Street address - English: Zanjan University of Medical Sciences, Azadi square, Zanjan, Iran
    Street address - Persian: ایران، زنجان، میدان آزادی، دانشگاه علوم پزشکی زنجان
    City - English: Zanjan
    City - Persian: زنجان
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Alireza Shoghli
    Full name of responsible person - Persian: دکتر علیرضا شغلی
    Street address - English: Zanjan University of Medical Sciences, Azadi square, Zanjan, Iran
    Street address - Persian: ایران، زنجان، میدان آزادی، دانشگاه علوم پزشکی زنجان
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Country: Iran (Islamic Republic of)
    Postal code: 4515613191
    Phone: +98 24 3315 6319
    Fax:
    Email: international@zums.ac.ir
    Web page address:
    empty
    Public
    empty
    Domestic
    empty
    Academic
    Chancellor of Research and Technology, Zanjan University of Medical Sciences (Primary sponsor)
    Zanjan University of Medical Sciences
    معاونت تحقیقات و فناوری دانشگاه علوم پزشکی زنجان
    دانشگاه علوم پزشکی زنجان

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Zanjan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی زنجان
    Full name of responsible person - English: Dr. Parisa Khoshnevis Asl
    Full name of responsible person - Persian: دکتر پریسا خوشنویس اصل
    Position - English: Pediatrician, Assistant professor
    Position - Persian: متخصص اطفال، استادیار
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pediatrics department, Ayatollah Moussavi Hospital, Gavazang street, Zanjan, Iran
    Street address - Persian: ایران، زنجان، خیابان گاوازنگ، بیمارستان آیت الله موسوی، بخش اطفال
    City - English: Zanjan
    City - Persian: زنجان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 243313328
    Mobile: +98 912 242 9374
    Fax:
    Email: khoshnevis@zums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Zanjan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی زنجان
    Full name of responsible person - English: Dr. Parisa Khoshnevis Asl
    Full name of responsible person - Persian: دکتر پریسا خوشنویس اصل
    Position - English: Pediatrician, Assistant professor
    Position - Persian: متخصص اطفال، استادیار
    Latest degree: specialist
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pediatrics department, Ayatollah Moussavi Hospital, Gavazang street, Zanjan, Iran
    Street address - Persian: ایران، زنجان، خیابان گاوازنگ، بیمارستان آیت الله موسوی، بخش اطفال
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 4515613191
    Phone: +98 243313328
    Mobile: +98 912 242 9374
    Fax:
    Email: khoshnevis@zums.ac.ir
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Zanjan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی زنجان
    Full name of responsible person - English: Dr. Parisa Khoshnevis Asl
    Full name of responsible person - Persian: دکتر پریسا خوشنویس اصل
    Position - English: Pediatrician, Assistant professor
    Position - Persian: متخصص اطفال، استادیار
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pediatrics department, Ayatollah Moussavi Hospital, Gavazang street, Zanjan, Iran
    Street address - Persian: ایران، زنجان، خیابان گاوازنگ، بیمارستان آیت الله موسوی، بخش اطفال
    City - English: Zanjan
    City - Persian: زنجان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 243313328
    Mobile: +98 912 242 9374
    Fax:
    Email: khoshnevis@zums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Zanjan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی زنجان
    Full name of responsible person - English: Dr. Parisa Khoshnevis Asl
    Full name of responsible person - Persian: دکتر پریسا خوشنویس اصل
    Position - English: Pediatrician, Assistant professor
    Position - Persian: متخصص اطفال، استادیار
    Latest degree: specialist
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pediatrics department, Ayatollah Moussavi Hospital, Gavazang street, Zanjan, Iran
    Street address - Persian: ایران، زنجان، خیابان گاوازنگ، بیمارستان آیت الله موسوی، بخش اطفال
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 4515613191
    Phone: +98 243313328
    Mobile: +98 912 242 9374
    Fax:
    Email: khoshnevis@zums.ac.ir
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Zanjan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی زنجان
    Full name of responsible person - English: Dr. Parisa Khoshnevis Asl
    Full name of responsible person - Persian: دکتر پریسا خوشنویس اصل
    Position - English: Pediatrician, Assistant professor
    Position - Persian: متخصص اطفال، استادیار
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pediatrics department, Ayatollah Moussavi Hospital, Gavazang street, Zanjan, Iran
    Street address - Persian: ایران، زنجان، خیابان گاوازنگ، بیمارستان آیت الله موسوی، بخش اطفال
    City - English: Zanjan
    City - Persian: زنجان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 243313328
    Mobile: +98 912 242 9374
    Fax:
    Email: khoshnevis@zums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Zanjan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی زنجان
    Full name of responsible person - English: Dr. Parisa Khoshnevis Asl
    Full name of responsible person - Persian: دکتر پریسا خوشنویس اصل
    Position - English: Pediatrician, Assistant professor
    Position - Persian: متخصص اطفال، استادیار
    Latest degree: specialist
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pediatrics department, Ayatollah Moussavi Hospital, Gavazang street, Zanjan, Iran
    Street address - Persian: ایران، زنجان، خیابان گاوازنگ، بیمارستان آیت الله موسوی، بخش اطفال
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 4515613191
    Phone: +98 243313328
    Mobile: +98 912 242 9374
    Fax:
    Email: khoshnevis@zums.ac.ir
    Web page address:

  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    empty
    It will be decided later
    empty
    بعدا تصمیم گیری می شود

Protocol summary

Study aim
Evaluate the effect of Zinc on Hyperbilirubinemia in newborn babies in Zanjan
Design
Randomized selection, double blind, control group of healthy children admitted to the neonatal ward
Settings and conduct
Place: Ayatollah Mousavi Hospital in Zanjan Blinded people: Participant, Care provider
Participants/Inclusion and exclusion criteria
Inclusion criteria: term infants; breast-feeding; jaundice; photo-therapy; serum bilirubin 15-20 mg / dL; age of 3 to 7 days; using no other drug. Exclusion criteria: recent weight loss; infection; hemolytic disease; oral intolerance; congenital birth defects; gastrointestinal anomalies; parental dissatisfaction for participation in the study; need for ventilators; need for blood transfusion
Intervention groups
Population studied: three to seven days old babies with Hyperbilirubinemia admitted to the neonatal ward of Ayatollah Mousavi Hospital in Zanjan. Sample size: 112 people Case study: prescribing Zinc and placebo syrup with a similar amount in three days in the case group and control group and measuring serum bilirubin in every three days. Time of intervention: no restrictions
Main outcome variables
Total bilirubin of serum levels, duration of photo-therapy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT2017061515835N5
Registration date: 2017-10-14, 1396/07/22
Registration timing: prospective

Last update: 2018-09-29, 1397/07/07
Update count: 2
Registration date
2017-10-14, 1396/07/22
Registrant information
Name
Parisa Khoshnevisasl
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 1427 2737
Email address
khoshnevis@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences, vice chancellor for research
Expected recruitment start date
2017-11-01, 1396/08/10
Expected recruitment end date
2018-09-01, 1397/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Zinc on Hyperbilirubinemia of healthy and normal newborns, a clinical trial
Public title
The effect of Zinc on Hyperbilirubinemia of newborns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Term infants Breast-feeding Jaundice Photo-therapy Serum bilirubin 15-20 mg/dL Age 3 to 7 days Using no other drug
Exclusion criteria:
recent weight loss infection hemolytic disease oral intolerance congenital birth defects gastrointestinal anomalies parental dissatisfaction for participation in the study need for ventilators need for blood transfusion
Age
From 3 days old to 7 days old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 112
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinded people: Participant, Care provider
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commite of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi square, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2017-06-06, 1396/03/16
Ethics committee reference number
ZUMS.REC.1396.30

Health conditions studied

1

Description of health condition studied
Neonatal physiological jaundice
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified

Primary outcomes

1

Description
Total and direct bilirubin of serum
Timepoint
One time measuring before prescribing of Zink and immediately after that daily measurment in three days
Method of measurement
Colorimetric method by Lathe and Ruthven

Secondary outcomes

empty

Intervention groups

1

Description
Daily administration of 5 mg twice daily Zinc supplementation in case group until the newborn is admitted
Category
Treatment - Drugs

2

Description
Daily administration of 5 mg twice daily placebo in control group until the newborn is admitted
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital
Full name of responsible person
Dr. Parisa Khoshnevis Asl
Street address
Ayatollah Mousavi Hospital, Gavazang street, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3315 6319
Email
international@zums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Alireza Shoghli
Street address
Zanjan University of Medical Sciences, Azadi square, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3315 6319
Email
international@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Parisa Khoshnevis Asl
Position
Pediatrician, Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Pediatrics department, Ayatollah Moussavi Hospital, Gavazang street, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 243313328
Fax
Email
khoshnevis@zums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Parisa Khoshnevis Asl
Position
Pediatrician, Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Pediatrics department, Ayatollah Moussavi Hospital, Gavazang street, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 243313328
Fax
Email
khoshnevis@zums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Parisa Khoshnevis Asl
Position
Pediatrician, Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Pediatrics department, Ayatollah Moussavi Hospital, Gavazang street, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 243313328
Fax
Email
khoshnevis@zums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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