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    Clinical Trial Results:
    The Effects of Isovolumetric and Isoeffective Infusions of Colloid Versus Crystalloid on Renal Blood Flow and Cardiac Output

    Summary
    EudraCT number
    		 2013-003260-32
    Trial protocol
    		 GB  
    Global end of trial date
    12 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Apr 2019
    First version publication date
    14 Apr 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    13090
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Nottingham
    Sponsor organisation address
    Jubilee Campus, Triumph Road, Nottingham, United Kingdom, NG8 1DH
    Public contact
    Shone, University of Nottingham, +44 1159315679, dileep.lobo@nottingham.ac.uk
    Scientific contact
    Angela Shone, Professor Dileep Lobo, +44 115 8467906, sponsor@nottingham.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Nov 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Nov 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to determine the differential impact of isovolumetric and isoeffective infusions of crystalloid and gelatin on blood volume expansion - to test whether an infusion of a gelatin based colloid solution expands blood volume to a greater degree than an isovolumetric infusion of crystalloid, resulting in increased renal blood flow and perfusion, and cardiac output..
    Protection of trial subjects
    All interventions carried out on healthy volunteers in the presence of qualified doctors
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Sep 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    12
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period 02.10.2014 to 12.11.2015

    Pre-assignment
    Screening details
    		 12 healthy, male volunteers, aged between 18 and 40 and weight between 65 and 80 kg. 2 participants later withdrew and were excluded from the analysis.

    Period 1
    Period 1 title
    Started first infusion
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    A nurse note involved in the study in charge of blinding the investigational products, program the automated infusion pump, set up and start the infusion and remove infusion equipment upon completion of administration. Infusion bags covered with opaque bags, in a manner making it not possible to recognize the number of bags being infused. The infusion lines covered to mask the yellowish colour of Gelatine. The data shown on the screen of the automated infusion pump masked to the investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Arm A : reference Sterofundin
    Arm description
    		 Infusion A: received 1500mls of crystalloid (Sterofundin ISO®)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sterofundin ISO®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    1500mls of crystalloid (Sterofundin ISO®

    Arm title
    		 Arm B: 4% Gelaspan
    Arm description
    		 0.5 Litres of colloid (4% Gelaspan®)
    Arm type
    		 Experimental

    Investigational medicinal product name
    4% Gelaspan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.5 Litres of colloid (4% Gelaspan®)

    Arm title
    		 Arm C: collloid and crystalloid
    Arm description
    		 0.5 Litres of colloid plus 1 Litre of crystalloid (0.5 Litres 4% Gelaspan ® and 1 Litre of Sterofundin ISO ®)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sterofundin ISO®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    1500mls of crystalloid (Sterofundin ISO®

    Investigational medicinal product name
    4% Gelaspan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.5 Litres of colloid (4% Gelaspan®)

    Number of subjects in period 1
    		Arm A : reference Sterofundin Arm B: 4% Gelaspan Arm C: collloid and crystalloid
    Started
    10
    10
    10
    Completed
    10
    10
    10
    Period 2
    Period 2 title
    Received all infusions
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Arm A : reference Sterofundin
    Arm description
    		 Infusion A: received 1500mls of crystalloid (Sterofundin ISO®)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sterofundin ISO®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    1500mls of crystalloid (Sterofundin ISO®

    Arm title
    		 Arm B: 4% Gelaspan
    Arm description
    		 0.5 Litres of colloid (4% Gelaspan®)
    Arm type
    		 Experimental

    Investigational medicinal product name
    4% Gelaspan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.5 Litres of colloid (4% Gelaspan®)

    Arm title
    		 Arm C: collloid and crystalloid
    Arm description
    		 0.5 Litres of colloid plus 1 Litre of crystalloid (0.5 Litres 4% Gelaspan ® and 1 Litre of Sterofundin ISO ®)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sterofundin ISO®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    1500mls of crystalloid (Sterofundin ISO®

    Investigational medicinal product name
    4% Gelaspan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.5 Litres of colloid (4% Gelaspan®)

    Number of subjects in period 2
    		Arm A : reference Sterofundin Arm B: 4% Gelaspan Arm C: collloid and crystalloid
    Started
    10
    10
    10
    Completed
    10
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Started first infusion
    Reporting group description
    		 Number entered first infusion 10

    Reporting group values
    		 Started first infusion Total
    Number of subjects
    		 12 12
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 12 12
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Age
    Units: years
        arithmetic mean (standard deviation)
    		 23.9 ( 2.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 12 12
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 74.5 ( 5.7 ) -
    Height
    Units: Metres
        arithmetic mean (standard deviation)
    		 1.81 ( 0.1 ) -
    Body Mass Index
    Units: kg/m squared
        arithmetic mean (standard deviation)
    		 22.7 ( 1.6 ) -
    Haemoglobin
    Units: g/L
        arithmetic mean (standard deviation)
    		 150.1 ( 7.6 ) -
    Haematocrit
    Units: Percent
        arithmetic mean (standard deviation)
    		 43.9 ( 1.9 ) -
    Sodium
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 102.9 ( 1.3 ) -
    Serum bicarbonate
    Units: mmol/L
        arithmetic mean (standard deviation)
    		 28.2 ( 2.2 ) -
    Serum albumin
    Units: g/L
        arithmetic mean (standard deviation)
    		 41.2 ( 2.5 ) -
    Serum osmolality
    Units: mOsm/kg
        arithmetic mean (standard deviation)
    		 291 ( 2.5 ) -
    Creatinine
    Units: umol/L
        arithmetic mean (standard deviation)
    		 139.6 ( 37.9 ) -
    Calculated blood volume
    Units: Litres
        arithmetic mean (standard deviation)
    		 5.2 ( 1.6 ) -
    Subject analysis sets

    Subject analysis set title
    Infusion A versus Infusion B
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Differences between colloid versus crystalloid

    Subject analysis set title
    Infusion A versus Infusion C
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Difference between colloid versus crystalloid and colloid

    Subject analysis set title
    Infusion B versus Infusion C
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Difference between crystalloid and colloid/crystalloid

    Subject analysis sets values
    		 Infusion A versus Infusion B Infusion A versus Infusion C Infusion B versus Infusion C
    Number of subjects
    10
    10
    10
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    10
    10
    10
        From 65-84 years
        85 years and over
    Age continuous
    Age
    Units: years
        arithmetic mean (standard deviation)
    23.9 ( 2.8 )
    23.9 ( 2.8 )
    23.9 ( 2.8 )
    Gender categorical
    Units: Subjects
        Female
    0
    0
    0
        Male
    10
    10
    10
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Height
    Units: Metres
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Body Mass Index
    Units: kg/m squared
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Haemoglobin
    Units: g/L
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Haematocrit
    Units: Percent
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Sodium
    Units: mmol/L
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Serum bicarbonate
    Units: mmol/L
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Serum albumin
    Units: g/L
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Serum osmolality
    Units: mOsm/kg
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Creatinine
    Units: umol/L
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    Calculated blood volume
    Units: Litres
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    Arm A : reference Sterofundin
    Reporting group description
    		 Infusion A: received 1500mls of crystalloid (Sterofundin ISO®)

    Reporting group title
    Arm B: 4% Gelaspan
    Reporting group description
    		 0.5 Litres of colloid (4% Gelaspan®)

    Reporting group title
    Arm C: collloid and crystalloid
    Reporting group description
    		 0.5 Litres of colloid plus 1 Litre of crystalloid (0.5 Litres 4% Gelaspan ® and 1 Litre of Sterofundin ISO ®)
    Reporting group title
    Arm A : reference Sterofundin
    Reporting group description
    		 Infusion A: received 1500mls of crystalloid (Sterofundin ISO®)

    Reporting group title
    Arm B: 4% Gelaspan
    Reporting group description
    		 0.5 Litres of colloid (4% Gelaspan®)

    Reporting group title
    Arm C: collloid and crystalloid
    Reporting group description
    		 0.5 Litres of colloid plus 1 Litre of crystalloid (0.5 Litres 4% Gelaspan ® and 1 Litre of Sterofundin ISO ®)

    Subject analysis set title
    Infusion A versus Infusion B
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Differences between colloid versus crystalloid

    Subject analysis set title
    Infusion A versus Infusion C
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Difference between colloid versus crystalloid and colloid

    Subject analysis set title
    Infusion B versus Infusion C
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Difference between crystalloid and colloid/crystalloid

    Primary: Change in blood volume

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    End point title
    		 Change in blood volume
    End point description
    Change in blood volume over time. The end point values for each time point have been given in the attached table.
    End point type
    Primary
    End point timeframe
    Blood sampled at baseline and times 30, 60, 90, 120, 180 and 240 minutes
    End point values
    		 Arm A : reference Sterofundin Arm B: 4% Gelaspan Arm C: collloid and crystalloid Infusion A versus Infusion B Infusion A versus Infusion C Infusion B versus Infusion C
    Number of subjects analysed
    10
    10
    10
    10
    10
    10
    Units: Litres
    10
    10
    10
    10
    10
    10
    Attachments
    		 Blood volume
    Statistical analysis title
    		 Change in blood volume
    Statistical analysis description
    For all secondary endpoints the statistical analyses are presented in the attached tables.
    Comparison groups
    Infusion A versus Infusion B v Infusion A versus Infusion C v Infusion B versus Infusion C
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 > 0.05 [2]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [1] - Repeated measures ANOVA Change in blood volume (A v B, B v C, A v C)
    [2] - P > 0.05 for all comparisons.

    Secondary: Change in weight

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    End point title
    		 Change in weight
    End point description
    Weight change monitored at 0, 90, 120, 180 and 240 minutes after the start of the infusion The end point values for each time point have been given in the attached table.
    End point type
    Secondary
    End point timeframe
    0, 90, 120, 180, and 240 mins
    End point values
    		 Arm A : reference Sterofundin Arm B: 4% Gelaspan Arm C: collloid and crystalloid Infusion A versus Infusion B Infusion A versus Infusion C Infusion B versus Infusion C
    Number of subjects analysed
    10
    10
    10
    10
    10
    10
    Units: Kilograms
    10
    10
    10
    10
    10
    10
    Attachments
    		 Change in weight
    No statistical analyses for this end point

    Secondary: Change in haematocrit %

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    End point title
    		 Change in haematocrit %
    End point description
    The end point values for each time point have been given in the attached table.
    End point type
    Secondary
    End point timeframe
    Blood will be sampled at 60, 90, 120, 180 and 240 minutes after the start of the infusion
    End point values
    		 Infusion A versus Infusion B Infusion A versus Infusion C Infusion B versus Infusion C
    Number of subjects analysed
    10
    10
    10
    Units: percentage
    10
    10
    10
    Attachments
    		 Change in haematocrit
    No statistical analyses for this end point

    Secondary: Change in albumin %

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    End point title
    		 Change in albumin %
    End point description
    The end point values for each time point have been given in the attached table.
    End point type
    Secondary
    End point timeframe
    Blood sampled at baseline and times 0, 30, 60, 90, 120, 180 and 240 minutes
    End point values
    		 Arm A : reference Sterofundin Arm B: 4% Gelaspan Arm C: collloid and crystalloid Infusion A versus Infusion B Infusion A versus Infusion C Infusion B versus Infusion C
    Number of subjects analysed
    10
    10
    10
    10
    10
    10
    Units: percentage
    10
    10
    10
    10
    10
    10
    No statistical analyses for this end point

    Secondary: Serum sodium mmol/l

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    End point title
    		 Serum sodium mmol/l
    End point description
    The end point values for each time point have been given in the attached table.
    End point type
    Secondary
    End point timeframe
    Blood sampled at baseline and times 30, 60, 90, 120, 180 and 240 minutes
    End point values
    		 Arm A : reference Sterofundin Arm B: 4% Gelaspan Arm C: collloid and crystalloid Infusion A versus Infusion B Infusion A versus Infusion C Infusion B versus Infusion C
    Number of subjects analysed
    10
    10
    10
    10
    10
    10
    Units: mmol/l
    10
    10
    10
    10
    10
    10
    Attachments
    		 Serum Sodium
    No statistical analyses for this end point

    Secondary: Aortic flow (ml/s)

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    End point title
    		 Aortic flow (ml/s)
    End point description
    The end point values for each time point have been given in the attached table. Comparisons between groups using un-paired t-test, comparison over time using paired t-test.
    End point type
    Secondary
    End point timeframe
    MRI at -15, 7, 26, 54 and 83 minutes
    End point values
    		 Arm A : reference Sterofundin Arm B: 4% Gelaspan Arm C: collloid and crystalloid Infusion A versus Infusion B Infusion A versus Infusion C Infusion B versus Infusion C
    Number of subjects analysed
    10
    10
    10
    10
    10
    10
    Units: ml/s
    10
    10
    10
    10
    10
    10
    Attachments
    		 Aortic flow
    No statistical analyses for this end point

    Secondary: Serum chloride mmol/l

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    End point title
    		 Serum chloride mmol/l
    End point description
    The end point values for each time point have been given in the attached table.
    End point type
    Secondary
    End point timeframe
    Blood sampled at baseline and times 30, 60, 90, 120, 180 and 240 minutes
    End point values
    		 Arm A : reference Sterofundin Arm B: 4% Gelaspan Arm C: collloid and crystalloid Infusion A versus Infusion B Infusion A versus Infusion C Infusion B versus Infusion C
    Number of subjects analysed
    10
    10
    10
    10
    10
    10
    Units: mmol/l
    10
    10
    10
    10
    10
    10
    Attachments
    		 Serum Chloride
    No statistical analyses for this end point

    Secondary: Renal volume (ml)

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    End point title
    		 Renal volume (ml)
    End point description
    The end point values for each time point have been given in the attached table. Comparisons between groups using un-paired t-test, comparison over time using paired t-test.
    End point type
    Secondary
    End point timeframe
    MRI at -5, 10, 38, 57 and 90 min
    End point values
    		 Arm A : reference Sterofundin Arm B: 4% Gelaspan Arm C: collloid and crystalloid Infusion A versus Infusion B Infusion A versus Infusion C Infusion B versus Infusion C
    Number of subjects analysed
    10
    10
    10
    10
    10
    10
    Units: ml/s
    10
    10
    10
    10
    10
    10
    Attachments
    		 Renal volume
    No statistical analyses for this end point

    Secondary: Strong ion differences

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    End point title
    		 Strong ion differences
    End point description
    The end point values for each time point have been given in the attached table.
    End point type
    Secondary
    End point timeframe
    Blood sampled at baseline and times 30, 60, 90, 120, 180 and 240 minutes
    End point values
    		 Arm A : reference Sterofundin Arm B: 4% Gelaspan Arm C: collloid and crystalloid Infusion A versus Infusion B Infusion A versus Infusion C Infusion B versus Infusion C
    Number of subjects analysed
    10
    10
    10
    10
    10
    10
    Units: mmol/l
    10
    10
    10
    10
    10
    10
    Attachments
    		 Strong io difference
    No statistical analyses for this end point

    Secondary: Renal artery blood flow

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    End point title
    		 Renal artery blood flow
    End point description
    The end point values for each time point have been given in the attached table. Comparisons between groups using un-paired t-test, comparison over time using paired t-test.
    End point type
    Secondary
    End point timeframe
    MRI at -15, 15, 43, 62 and 95 min
    End point values
    		 Arm A : reference Sterofundin Arm B: 4% Gelaspan Arm C: collloid and crystalloid Infusion A versus Infusion B Infusion A versus Infusion C Infusion B versus Infusion C
    Number of subjects analysed
    10
    10
    10
    10
    10
    10
    Units: ml/s
    10
    10
    10
    10
    10
    10
    Attachments
    		 Renal flow
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1.0
    Reporting groups
    Reporting group title
    All groups
    Reporting group description
    		 -

    Serious adverse events
    		 All groups
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 All groups
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 10 (20.00%)
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    2 / 10 (20.00%)
         occurrences all number
    2
    General disorders and administration site conditions
    Excessive sweating
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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