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    Clinical Trial Results:
    Granulocyte colony stimulating factor (G-CSF) to treat acute-on-chronic liver failure: A multicentre randomized Trial

    Summary
    EudraCT number
    		 2015-002212-32
    Trial protocol
    		 DE  
    Global end of trial date
    17 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jun 2021
    First version publication date
    28 Jun 2021
    Other versions
    Summary report(s)
    		 _GRAFT_Ergebnisbericht_in_Arzneimittelpruefungen_final2.0_2021-04-12
    SAE per Arm
    AE per Arm (>8x reported per Term)

    Trial information

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    Trial identification
    Sponsor protocol code
    GRAFT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02669680
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 DRKS: DRKS00011572
    Sponsors
    Sponsor organisation name
    Universität Leipzig
    Sponsor organisation address
    Ritterstr. 26, Leipzig, Germany,
    Public contact
    Thomas Berg, Universität Leipzig, thomas.berg@medizin.uni-leipzig.de
    Scientific contact
    Thomas Berg, Universität Leipzig, thomas.berg@medizin.uni-leipzig.de
    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
    11 May 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    From the clinical point of view, overall survival and transplant-free survival are the most relevant outcome measures. Thus, the primary endpoint of the study is transplant-free survival up to 90 days, with death and liver transplantation (OLT) counting as event
    Protection of trial subjects
    For the analysis of clinical endpoints, blood samples were taken and other diagnostic procedures were performed, all standardized according to the current position papers and guidelines. These were generally consistent with the routine treatment of these patients - except for the intervention with G-CSF in the experimental arm.
    Background therapy
    		 n.a.
    Evidence for comparator
    		 n.a.
    Actual start date of recruitment
    01 Mar 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 176
    Worldwide total number of subjects
    176
    EEA total number of subjects
    176
    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)
    176
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First patient in: 01. March 2016 Last patient in: 04. April 2019 Last patient out: 17. March 2020

    Pre-assignment
    Screening details
    		 The aim was to include a total number of 262 patients with evaluable data with regard to the primary and secondary endpoints after intervention with G-CSF or only standard care. To obtain reliable information, 292 patients were planned to be screened and randomized.

    Pre-assignment period milestones
    Number of subjects started
    		 176
    Number of subjects completed
    		 176

    Period 1
    Period 1 title
    Intervention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    n.a.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 G-CSF+SMT
    Arm description
    		 Application of G-CSF (Filgrastim) in combination with standard care of acute-on-chronic liver failure G-CSF subcutaneously, on day 0-4, then every 3rd day over 26 days (days 7, 10, 13, 16, 19, 22, 25) = 12 doses
    Arm type
    		 Experimental

    Investigational medicinal product name
    G-CSF
    Investigational medicinal product code
    n.a.
    Other name
    Filgrastim
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    G-CSF subcutaneously, on day 0-4, then every 3rd day over 26 days (days 7, 10, 13, 16, 19, 22, 25) = 12 doses G-CSF doses should be guided by the body weight using a cut off value of 70 kg (≤ 70kg 30 Mio IU G-CSF, > 70 kg 48 Mio IU G-CSF)

    Arm title
    		 SMT=control
    Arm description
    		 Standard medical treatment/care of acute-on-chronic liver failure
    Arm type
    		 control

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		G-CSF+SMT SMT=control
    Started
    88
    88
    Completed
    88
    88

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    G-CSF+SMT
    Reporting group description
    		 Application of G-CSF (Filgrastim) in combination with standard care of acute-on-chronic liver failure G-CSF subcutaneously, on day 0-4, then every 3rd day over 26 days (days 7, 10, 13, 16, 19, 22, 25) = 12 doses

    Reporting group title
    SMT=control
    Reporting group description
    		 Standard medical treatment/care of acute-on-chronic liver failure

    Reporting group values
    		 G-CSF+SMT SMT=control Total
    Number of subjects
    		 88 88 176
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Age at trial inclusion
    Units: years
        arithmetic mean (standard deviation)
    		 54.4 ± 10.2 57.1 ± 9.6 -
    Gender categorical
    Units: Subjects
        Female
    		 38 27 65
        Male
    		 50 61 111
    ACLF grade at inclusion
    Units: Subjects
        grade 1
    		 39 45 84
        grade 2
    		 37 28 65
        grade 3
    		 12 15 27
    Ascites
    Units: Subjects
        yes
    		 85 85 170
        no
    		 2 3 5
        unknown
    		 1 0 1
    hepatic encephalopathy
    HE at inclusion
    Units: Subjects
        no
    		 32 26 58
        unknown
    		 1 1 2
        yes
    		 55 61 116
    number of organ failures
    Units: count
        arithmetic mean (standard deviation)
    		 1.7 ± 0.7 1.4 ± 0.6 -
    CLIF-C OF score
    Units: count
        arithmetic mean (standard deviation)
    		 10.4 ± 1.9 10.3 ± 2.0 -
    MELD score
    Units: count
        arithmetic mean (standard deviation)
    		 24.4 ± 6.3 24.5 ± 6.1 -
    CLIF-C ACLF score
    Units: count
        arithmetic mean (standard deviation)
    		 51.9 ± 8.7 51.2 ± 7.4 -
    BMI
    Units: kg/m²
        arithmetic mean (standard deviation)
    		 28.9 ± 4.8 28.8 ± 5.6 -
    MAP
    Units: mm Hg
        arithmetic mean (standard deviation)
    		 79.9 ± 12.0 82.7 ± 13.2 -
    bilirubin
    Units: mg/dl
        arithmetic mean (standard deviation)
    		 18.0 ± 12.0 18.9 ± 14.5 -
    creatinine
    Units: mg/dl
        arithmetic mean (standard deviation)
    		 2.4 ± 1.6 2.4 ± 1.5 -
    INR
    Units: ratio
        arithmetic mean (standard deviation)
    		 2.2 ± 0.8 2.1 ± 1.0 -
    WBC
    Units: Gpt/l
        arithmetic mean (standard deviation)
    		 14.8 ± 12.4 11.2 ± 7.1 -

    End points

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    End points reporting groups
    Reporting group title
    G-CSF+SMT
    Reporting group description
    		 Application of G-CSF (Filgrastim) in combination with standard care of acute-on-chronic liver failure G-CSF subcutaneously, on day 0-4, then every 3rd day over 26 days (days 7, 10, 13, 16, 19, 22, 25) = 12 doses

    Reporting group title
    SMT=control
    Reporting group description
    		 Standard medical treatment/care of acute-on-chronic liver failure

    Primary: transplant-free survival at Day 90/ visit 6

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    End point title
    		 transplant-free survival at Day 90/ visit 6
    End point description
    either OLT or death = event
    End point type
    Primary
    End point timeframe
    Day 90 = visit 6
    End point values
    		 G-CSF+SMT SMT=control
    Number of subjects analysed
    88 [1]
    88 [2]
    Units: subjests
        event occurred
    54
    51
        censored
    34
    37
    Notes
    [1] - = Full analysis population
    [2] - = Fullanalysis population
    Statistical analysis title
    		 confirmatory
    Comparison groups
    G-CSF+SMT v SMT=control
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.805
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.711
         upper limit
    		 1.551
    Notes
    [3] - Cox regression model

    Secondary: overall survival

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    End point title
    		 overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    Day 360 = visit 8 = end of study
    End point values
    		 G-CSF+SMT SMT=control
    Number of subjects analysed
    88
    88
    Units: subjects
        death occurred
    58
    55
        censored
    30
    33
    Statistical analysis title
    		 secondary
    Comparison groups
    G-CSF+SMT v SMT=control
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.768
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.058
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.727
         upper limit
    		 1.541

    Secondary: transplant-free survival at Day 360 =End of Study

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    End point title
    		 transplant-free survival at Day 360 =End of Study
    End point description
    End point type
    Secondary
    End point timeframe
    Day 360 = End of study
    End point values
    		 G-CSF+SMT SMT=control
    Number of subjects analysed
    88
    88
    Units: Subjects
        event occurred
    62
    61
        censored
    26
    27
    Statistical analysis title
    		 secondary
    Comparison groups
    G-CSF+SMT v SMT=control
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.992
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.998
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.697
         upper limit
    		 1.43
    Statistical analysis title
    		 secondary
    Comparison groups
    SMT=control v G-CSF+SMT
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.992
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.998
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.697
         upper limit
    		 1.43

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Until Day 28; only in case of new malignancies until Day360 but no one was reported
    Adverse event reporting additional description
    A selection of SAE with fatal outcomes and SAR were reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    GCSF+SMT
    Reporting group description
    		 GCSF + standard medical treatment

    Reporting group title
    SMT=control
    Reporting group description
    		 standard medical treatment

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: In total, 757 AE were reported with 403 in 80 patients of the G-CSF arm and 354 in 78 Patients of the SMT control arm. All AE (k=338, with) with frequncies of (at least) 8 occurrences per MedDRA Preferred term were provided per arm in a PDF-File attachted.
    Serious adverse events
    		 GCSF+SMT SMT=control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    54 / 88 (61.36%)
    47 / 88 (53.41%)
         number of deaths (all causes)
    58
    55
         number of deaths resulting from adverse events
    37
    36
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 88 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Hypotension
         subjects affected / exposed
    2 / 88 (2.27%)
    2 / 88 (2.27%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 88 (3.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Surgical and medical procedures
    Resuscitation
         subjects affected / exposed
    2 / 88 (2.27%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Endotracheal intubation
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    General disorders and administration site conditions
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    11 / 88 (12.50%)
    9 / 88 (10.23%)
         occurrences causally related to treatment / all
    2 / 11
    0 / 9
         deaths causally related to treatment / all
    2 / 10
    0 / 9
    Ulcer haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    3 / 88 (3.41%)
    6 / 88 (6.82%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 6
         deaths causally related to treatment / all
    1 / 3
    0 / 2
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Asphyxia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aspiration
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Investigations
    Transaminases increased
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Right ventricular failure
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiovascular insufficiency
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Hepatic encephalopathy
         subjects affected / exposed
    5 / 88 (5.68%)
    10 / 88 (11.36%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 10
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Coma hepatic
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Coagulopathy
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    5 / 88 (5.68%)
    4 / 88 (4.55%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Ileus
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intestinal haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intestinal ischaemia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intestinal varices haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oesophageal varices haemorrhage
         subjects affected / exposed
    2 / 88 (2.27%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 88 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Hepatobiliary disorders
    Acute on chronic liver failure
         subjects affected / exposed
    8 / 88 (9.09%)
    7 / 88 (7.95%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 8
    0 / 7
    Hepatic cirrhosis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatic failure
         subjects affected / exposed
    5 / 88 (5.68%)
    6 / 88 (6.82%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 4
    0 / 6
    Hepatorenal syndrome
         subjects affected / exposed
    6 / 88 (6.82%)
    6 / 88 (6.82%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Hepatic function abnormal
         subjects affected / exposed
    2 / 88 (2.27%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    Renal failure
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infections and infestations
    Peritonitis bacterial
         subjects affected / exposed
    1 / 88 (1.14%)
    3 / 88 (3.41%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 3
         deaths causally related to treatment / all
    1 / 1
    0 / 3
    Pneumonia
         subjects affected / exposed
    1 / 88 (1.14%)
    4 / 88 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Sepsis
         subjects affected / exposed
    3 / 88 (3.41%)
    3 / 88 (3.41%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Septic shock
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Urosepsis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary sepsis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Infection
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 88 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Influenza
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metabolism and nutrition disorders
    Lactic acidosis
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 GCSF+SMT SMT=control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 88 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jun 2016
    changes in exclusion criteria, baseline assessments and documentation and reporting of AE/SAE
    29 Nov 2016
    addition of new trial sites, change of coordinating investigator
    27 Jul 2018
    changes in documentation and reporting of AE/SAE because of new safety information, addition of a new trial site

    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.
    n.a.
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