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    Clinical Trial Results:
    A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Effects of 4 Weeks Treatment with Subcutaneous Elamipretide on Left Ventricular Function in Subjects with Stable Heart Failure with Preserved Ejection Fraction.

    Summary
    EudraCT number
    		 2015-005615-32
    Trial protocol
    		 DE  
    Global end of trial date
    28 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Dec 2020
    First version publication date
    19 Dec 2020
    Other versions
    Summary report(s)
    		 SPIHF-203 Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    SPIHF-203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Stealth BioTherapeutics, Inc.
    Sponsor organisation address
    275 Grove Street, Suite 3-107, Newton, United States, MA 02466
    Public contact
    Matthew Millstein, Stealth BioTherapeutics Inc., 001 6177622539, matthew.millstein@stealthbt.com
    Scientific contact
    Matthew Millstein, Stealth BioTherapeutics Inc., 001 6177622539, matthew.millstein@stealthbt.com
    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
    04 May 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective of the study is to evaluate the effects of 4 weeks of daily SC administration of elamipretide on the ratio between early mitral inflow velocity and mitral annular early diastolic velocity (E/e’) at rest as assessed by transthoracic echocardiography.
    Protection of trial subjects
    This study was conducted in strict accordance with the Council for International Organizations of Medical Sciences International Ethical Guidelines, ICH GCP guideline, and all applicable laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 May 2016
    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
    Germany: 10
    Country: Number of subjects enrolled
    Serbia: 37
    Worldwide total number of subjects
    47
    EEA total number of subjects
    10
    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)
    9
    From 65 to 84 years
    38
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The subjects were recruited in 2 countries in Europe (Germany and Serbia) at 9 study centers.

    Pre-assignment
    Screening details
    		 Subjects' study eligibility was determined during the Screening period, which began with the signature of the ICF and lasted up to 7 days. Tests and assessments were performed. Subjects who met all study requirements, including all inclusion and none of the exclusion criteria, entered the Treatment period.

    Period 1
    Period 1 title
    Treatment
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Elamipretide 40 mg
    Arm description
    		 A 4 week treatment with 40 mg elamipretide administered subcutaneously once daily on top of usual care. Study medication was administered in the abdomen (rotating clockwise around the 4 abdominal quadrants) by either the clinical site staff or a visiting nurse.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elamipretide
    Investigational medicinal product code
    Other name
    MTP-131
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    40 mg administered subcutaneously once daily for 28 consecutive days

    Arm title
    		 Placebo
    Arm description
    		 A 4 weeks treatment with placebo handled and administered identically to the active drug.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects randomized to placebo received a subcutaneous injection containing 1 mL of sterile solution once daily

    Number of subjects in period 1
    		Elamipretide 40 mg Placebo
    Started
    23
    24
    Completed
    22
    23
    Not completed
    1
    1
         Consent withdrawn by subject
    -
    1
         Subject's request
    1
    -
    Period 2
    Period 2 title
    Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Elamipretide 40 mg
    Arm description
    		 A 4 week treatment with 40 mg elamipretide administered subcutaneously once daily on top of usual care. Study medication was administered in the abdomen (rotating clockwise around the 4 abdominal quadrants) by either the clinical site staff or a visiting nurse.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elamipretide
    Investigational medicinal product code
    Other name
    MTP-131
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    40 mg administered subcutaneously once daily for 28 consecutive days

    Arm title
    		 Placebo
    Arm description
    		 A 4 weeks treatment with placebo handled and administered identically to the active drug.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects randomized to placebo received a subcutaneous injection containing 1 mL of sterile solution once daily

    Number of subjects in period 2
    		Elamipretide 40 mg Placebo
    Started
    22
    23
    Completed
    22
    23

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Elamipretide 40 mg
    Reporting group description
    		 A 4 week treatment with 40 mg elamipretide administered subcutaneously once daily on top of usual care. Study medication was administered in the abdomen (rotating clockwise around the 4 abdominal quadrants) by either the clinical site staff or a visiting nurse.

    Reporting group title
    Placebo
    Reporting group description
    		 A 4 weeks treatment with placebo handled and administered identically to the active drug.

    Reporting group values
    		 Elamipretide 40 mg Placebo Total
    Number of subjects
    		 23 24 47
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 5 4 9
        From 65-84 years
    		 18 20 38
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 16 14 30
        Male
    		 7 10 17
    Subject analysis sets

    Subject analysis set title
    mITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Endpoint were analyzed using modified intention-to-treat (mITT) population, which included all study subjects who received at least 1 dose of IMP.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Population (i.e. all study subjects who received at least 1 dose of IMP) was used for Safety analysis.

    Subject analysis sets values
    		 mITT Safety Population
    Number of subjects
    47
    47
    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)
    9
    9
        From 65-84 years
    38
    38
        85 years and over
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Elamipretide 40 mg
    Reporting group description
    		 A 4 week treatment with 40 mg elamipretide administered subcutaneously once daily on top of usual care. Study medication was administered in the abdomen (rotating clockwise around the 4 abdominal quadrants) by either the clinical site staff or a visiting nurse.

    Reporting group title
    Placebo
    Reporting group description
    		 A 4 weeks treatment with placebo handled and administered identically to the active drug.
    Reporting group title
    Elamipretide 40 mg
    Reporting group description
    		 A 4 week treatment with 40 mg elamipretide administered subcutaneously once daily on top of usual care. Study medication was administered in the abdomen (rotating clockwise around the 4 abdominal quadrants) by either the clinical site staff or a visiting nurse.

    Reporting group title
    Placebo
    Reporting group description
    		 A 4 weeks treatment with placebo handled and administered identically to the active drug.

    Subject analysis set title
    mITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Endpoint were analyzed using modified intention-to-treat (mITT) population, which included all study subjects who received at least 1 dose of IMP.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Population (i.e. all study subjects who received at least 1 dose of IMP) was used for Safety analysis.

    Primary: Changes in septal E/e’ at rest between Visit 1 and Visit 5

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    End point title
    		 Changes in septal E/e’ at rest between Visit 1 and Visit 5
    End point description
    End point type
    Primary
    End point timeframe
    Visit 1 to Visit 5
    End point values
    		 Elamipretide 40 mg Placebo
    Number of subjects analysed
    23
    24
    Units: unit(s)
        arithmetic mean (standard deviation)
    -0.7 ( 3.08 )
    0.1 ( 4.52 )
    Statistical analysis title
    		 Analysis of covariance (ANCOVA) model
    Comparison groups
    Placebo v Elamipretide 40 mg
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 ANCOVA
    Confidence interval

    Primary: Change in lateral E/e’ at Rest from Visit 1 to Visit 5

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    End point title
    		 Change in lateral E/e’ at Rest from Visit 1 to Visit 5
    End point description
    End point type
    Primary
    End point timeframe
    Visit 1 to Visit 5
    End point values
    		 Elamipretide 40 mg Placebo
    Number of subjects analysed
    23
    24
    Units: unit(s)
        arithmetic mean (standard deviation)
    -0.5 ( 3.80 )
    -1.1 ( 3.82 )
    Statistical analysis title
    		 Analysis of covariance (ANCOVA) model
    Comparison groups
    Elamipretide 40 mg v Placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 ANCOVA
    Confidence interval

    Primary: Change in average E/e’ at Rest from Visit 1 to Visit 5

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    End point title
    		 Change in average E/e’ at Rest from Visit 1 to Visit 5
    End point description
    End point type
    Primary
    End point timeframe
    Visit 1 to Visit 5
    End point values
    		 Elamipretide 40 mg Placebo
    Number of subjects analysed
    23
    24
    Units: unit(s)
        arithmetic mean (standard deviation)
    -0.5 ( 3.22 )
    -0.6 ( 3.50 )
    Statistical analysis title
    		 Analysis of covariance (ANCOVA) model
    Comparison groups
    Elamipretide 40 mg v Placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Changes in septal E/e’ at maximum workload from Visit 1 to Visit 5

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    End point title
    		 Changes in septal E/e’ at maximum workload from Visit 1 to Visit 5
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 1 to Visit 5
    End point values
    		 Elamipretide 40 mg Placebo
    Number of subjects analysed
    23
    24
    Units: unit(s)
        arithmetic mean (standard deviation)
    -1.0 ( 5.11 )
    6.66 ( 0.9 )
    No statistical analyses for this end point

    Secondary: Change in LV systolic GLS at rest from Visit 1 to Visit 5

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    End point title
    		 Change in LV systolic GLS at rest from Visit 1 to Visit 5
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 1 to Visit 5
    End point values
    		 Elamipretide 40 mg Placebo
    Number of subjects analysed
    23
    24
    Units: unit(s)
        arithmetic mean (standard deviation)
    0.8 ( 2.71 )
    -0.7 ( 2.64 )
    Statistical analysis title
    		 Analysis of covariance (ANCOVA) model
    Comparison groups
    Elamipretide 40 mg v Placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in LV systolic GLS during maximal workload from Visit 1 to Visit 5

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    End point title
    		 Change in LV systolic GLS during maximal workload from Visit 1 to Visit 5
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 1 to Visit 5
    End point values
    		 Elamipretide 40 mg Placebo
    Number of subjects analysed
    23
    24
    Units: unit(s)
        arithmetic mean (standard deviation)
    -3.1 ( 5.61 )
    -0.3 ( 3.20 )
    Statistical analysis title
    		 Analysis of covariance (ANCOVA) model
    Comparison groups
    Elamipretide 40 mg v Placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in 6MWT from Visit 1 to Visit 5

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    End point title
    		 Change in 6MWT from Visit 1 to Visit 5
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 1 to Visit 5
    End point values
    		 Elamipretide 40 mg Placebo
    Number of subjects analysed
    23
    24
    Units: unit(s)
        arithmetic mean (standard deviation)
    29.6 ( 55.33 )
    28.1 ( 69.79 )
    Statistical analysis title
    		 Analysis of covariance (ANCOVA) model
    Comparison groups
    Elamipretide 40 mg v Placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in NT proBNP (log-transformed) from Visit 1 to Visit 5

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    End point title
    		 Change in NT proBNP (log-transformed) from Visit 1 to Visit 5
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 1 to Visit 5
    End point values
    		 Elamipretide 40 mg Placebo
    Number of subjects analysed
    23
    24
    Units: unit(s)
        arithmetic mean (standard deviation)
    -0.1 ( 0.52 )
    -0.0 ( 0.53 )
    Statistical analysis title
    		 Analysis of covariance (ANCOVA) model
    Comparison groups
    Elamipretide 40 mg v Placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in lateral E/e’ At Maximal Workload from Visit 1 to Visit 5

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    End point title
    		 Change in lateral E/e’ At Maximal Workload from Visit 1 to Visit 5
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 1 to Visit 5
    End point values
    		 Elamipretide 40 mg Placebo
    Number of subjects analysed
    23
    24
    Units: unit(s)
        arithmetic mean (standard deviation)
    -1.3 ( 4.15 )
    -2.0 ( 4.81 )
    Statistical analysis title
    		 Analysis of covariance (ANCOVA) model
    Comparison groups
    Elamipretide 40 mg v Placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Change in average E/e’ At Maximal Workload from Visit 1 to Visit 5

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    End point title
    		 Change in average E/e’ At Maximal Workload from Visit 1 to Visit 5
    End point description
    End point type
    Secondary
    End point timeframe
    Visit 1 to Visit 5
    End point values
    		 Elamipretide 40 mg Placebo
    Number of subjects analysed
    23
    24
    Units: unit(s)
        arithmetic mean (standard deviation)
    -1.4 ( 4.02 )
    -1.4 ( 4.20 )
    Statistical analysis title
    		 Analysis of covariance (ANCOVA) model
    Comparison groups
    Elamipretide 40 mg v Placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The period between the first dose of study treatment and 30 days after the last dose.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Elamipretide 40 mg
    Reporting group description
    		 A 4 week treatment with 40 mg elamipretide administered subcutaneously once daily on top of usual care

    Reporting group title
    Placebo
    Reporting group description
    		 A 4 weeks treatment with placebo handled and administered identically to the active drug.

    Serious adverse events
    		 Elamipretide 40 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         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
    Sudden death
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Elamipretide 40 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 23 (60.87%)
    6 / 24 (25.00%)
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Subcutaneous haematoma
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Hypotension
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    9
    1
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    5 / 23 (21.74%)
    0 / 24 (0.00%)
         occurrences all number
    5
    0
    Application site erythema
         subjects affected / exposed
    4 / 23 (17.39%)
    0 / 24 (0.00%)
         occurrences all number
    4
    0
    Injection site swelling
         subjects affected / exposed
    4 / 23 (17.39%)
    0 / 24 (0.00%)
         occurrences all number
    4
    0
    Injection site pruritus
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 24 (4.17%)
         occurrences all number
    2
    1
    Application site bruise
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Application site oedema
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Application site pain
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Application site pruritus
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Injection site bruising
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Injection site reaction
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Asymptomatic bacteriuria
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Apr 2016
    Amendment 1 (Version 4.0) implemented changes to study procedures and inclusion/exclusion criteria due to requirements of the Ethics Committee, clarified efficacy measures, and added information regarding SAE reporting and other regulatory considerations.
    23 May 2016
    Amendment 2 (Version 5.0), implemented further changes to inclusion/exclusion criteria, clarified the schedule of INR determinations for subjects in Serbia vs those in Germany, and required for Serbian sites that study drug be administered at the clinical site/hospital. In addition, general formatting and other administrative changes were made throughout the document.
    01 Nov 2016
    Amendment 3 (Version 6.0), implemented several updates to the study protocol in an effort to improve subject recruitment and reduce the high number of screening failures. Examples of these changes included increasing the maximum number of study sites from 8 to 9, changes to inclusion and exclusion criteria, updates to primary and secondary efficacy measures, and allowance for laboratory screening values to be measured locally for purposes of randomization

    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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