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    Clinical Trial Results:
    A comparison of the efficacy of Symbicort® SMARTª (Symbicort Turbuhaler® 160/4.5 μg 1 inhalation bi.d. plus as-needed) and conventional best standard treatment for the treatment of persistent asthma in adolescents and adults. A randomized, open, parallel-group, multicentre, 26 weeks study.

    Summary
    EudraCT number
    2004-000679-32
    Trial protocol
    FI  
    Global end of trial date
    27 Feb 2008

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Apr 2016
    First version publication date
    28 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D5890L00008
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Roskildevej 22, 2620 Albertslund, Denmark,
    Public contact
    Stig Waldorff, M, AstraZeneca, clinicaltrialtranparency@astrazeneca.com
    Scientific contact
    Stig Waldorff, M, AstraZeneca, clinicaltrialtranparency@astrazeneca.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
    27 Feb 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Feb 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Feb 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to compare the efficacy of treatment with Symbicort® Maintenance and Reliever Therapy (Symbicort® SMART) with treatment according to conventional best practice treatment in patients with persistent asthma.
    Protection of trial subjects
    The final study protocol, including the final version of the Written Informed Consent Form, was approved or given a favourable opinion in writing by an IRB or IEC. The coordinating investigator in each country submitted written approval to AstraZeneca before enrolling any patient into the study. The principal investigator(s) at each centre ensured that the patient/patients legally acceptable representative was given full and adequate oral and written information about the nature, purpose, possible risk and benefit of the study. Patients were also notified that they were free to discontinue from the study at any time. The patients were given the opportunity to ask questions and allowed time to consider the information provided. The patient’s signed and dated informed consent were obtained before conducting any procedure specifically for the study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    13 Sep 2004
    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
    Finland: 418
    Country: Number of subjects enrolled
    Denmark: 800
    Country: Number of subjects enrolled
    Norway: 617
    Worldwide total number of subjects
    1835
    EEA total number of subjects
    1835
    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)
    85
    Adults (18-64 years)
    1582
    From 65 to 84 years
    164
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    This was a multicentre trial conducted in 3 countries between September 2004 and October 2006.

    Pre-assignment
    Screening details
    The study consisted of an enrolment/randomization visit, a randomization at Visit 1, and 3 further visits (Visits 2-4) at 4, 13 and 26 weeks. Subjects received 1 of 2 open label treatments allocated in a random order.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    SMART
    Arm description
    Symbicort® Turbuhaler®
    Arm type
    Experimental

    Investigational medicinal product name
    Symbicort® Turbuhaler®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    160/4.5 μg/ dose budesonide/formoterol twice daily

    Arm title
    CBP (Conventional best practice)
    Arm description
    Conventional best practice
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    SMART CBP (Conventional best practice)
    Started
    921
    914
    Completed
    818
    849
    Not completed
    103
    65
         Protocol deviation
             30
             30
         Adverse event, non-fatal
             21
             9
         Consent withdrawn by subject
             22
             8
         Other reasons
             18
             6
         Lost to follow-up
             12
             12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SMART
    Reporting group description
    Symbicort® Turbuhaler®

    Reporting group title
    CBP (Conventional best practice)
    Reporting group description
    Conventional best practice

    Reporting group values
    SMART CBP (Conventional best practice) Total
    Number of subjects
    921 914 1835
    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)
    43 42 85
        Adults (18-64 years)
    790 792 1582
        From 65-84 years
    86 78 164
        85 years and over
    2 2 4
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    43 ± 15.9 42 ± 15.9 -
    Gender Categorical
    Units: Subjects
        Female
    559 536 1095
        Male
    362 378 740
    Race
    Units: Subjects
        Caucasian
    911 901 1812
        Black
    0 1 1
        Oriental
    5 8 13
        Other
    5 4 9

    End points

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    End points reporting groups
    Reporting group title
    SMART
    Reporting group description
    Symbicort® Turbuhaler®

    Reporting group title
    CBP (Conventional best practice)
    Reporting group description
    Conventional best practice

    Primary: Subjects with at least one severe exacerbations

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    End point title
    Subjects with at least one severe exacerbations
    End point description
    End point type
    Primary
    End point timeframe
    26 weeks
    End point values
    SMART CBP (Conventional best practice)
    Number of subjects analysed
    921
    914
    Units: Subjects
    58
    73
    Statistical analysis title
    Time to first severe exacerbation
    Comparison groups
    SMART v CBP (Conventional best practice)
    Number of subjects included in analysis
    1835
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.189
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.79
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.56
         upper limit
    1.12

    Secondary: Number of severe exacerbations

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    End point title
    Number of severe exacerbations
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    SMART CBP (Conventional best practice)
    Number of subjects analysed
    921
    914
    Units: number of severe exacerbations
        No. with 1 event
    51
    59
        No. with 2 events
    3
    7
        No. with 3 events
    4
    6
        No with > 3 events
    0
    1
    Statistical analysis title
    Total number of severe exacerbations
    Comparison groups
    SMART v CBP (Conventional best practice)
    Number of subjects included in analysis
    1835
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.058
    Method
    Poisson Regression
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.741
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.543
         upper limit
    1.01

    Secondary: Average no. of as needed inhalations per day

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    End point title
    Average no. of as needed inhalations per day
    End point description
    End point type
    Secondary
    End point timeframe
    26 weks
    End point values
    SMART CBP (Conventional best practice)
    Number of subjects analysed
    898
    898
    Units: average inhalations per day
        arithmetic mean (full range (min-max))
    0.99 (0 to 10)
    0.96 (0 to 9)
    Statistical analysis title
    Average no. of as needed inhalations per day
    Comparison groups
    SMART v CBP (Conventional best practice)
    Number of subjects included in analysis
    1796
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.9809
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    0.001
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.109
         upper limit
    0.112

    Secondary: Mean daily dose of inhaled steroids

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    End point title
    Mean daily dose of inhaled steroids
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    SMART CBP (Conventional best practice)
    Number of subjects analysed
    921
    914
    Units: μg
        arithmetic mean (full range (min-max))
    482 (320 to 1920)
    670 (21 to 3000)
    Statistical analysis title
    Mean daily dose of inhaled steroids
    Comparison groups
    SMART v CBP (Conventional best practice)
    Number of subjects included in analysis
    1835
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    187.96
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    160
         upper limit
    215.9

    Secondary: Asthma Control Questionnaire

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    End point title
    Asthma Control Questionnaire
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    SMART CBP (Conventional best practice)
    Number of subjects analysed
    899
    897
    Units: average
        arithmetic mean (full range (min-max))
    1.03 (0 to 4.3)
    1.08 (0 to 4.6)
    Statistical analysis title
    Change in Asthma Control Questionnaire
    Comparison groups
    SMART v CBP (Conventional best practice)
    Number of subjects included in analysis
    1796
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.003
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.09
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.15
         upper limit
    -0.03

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Only serious AEs and AEs leading to discontinuation were collected from visit 1 until visit 4 (26 weeks after randomization). Only events occuring on or after first dose of study medication are included in the summaries.
    Adverse event reporting additional description
    A total of 63 patients reported non-serious adverse events; 30 on SMART, 33 on CBP. Numbers for non-serious AEs in the reporting group table are based on the 1% threshold frequency.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    SMART
    Reporting group description
    Symbicort® Turbuhaler®

    Reporting group title
    CBP (Conventional best practice)
    Reporting group description
    Conventional best practice

    Serious adverse events
    SMART CBP (Conventional best practice)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    25 / 921 (2.71%)
    25 / 914 (2.74%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 921 (0.00%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 921 (0.00%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Drug abuser
         subjects affected / exposed
    0 / 921 (0.00%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 921 (0.11%)
    0 / 914 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 921 (0.00%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 921 (0.00%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 921 (0.11%)
    0 / 914 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 921 (0.11%)
    0 / 914 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Postmenopausal haemorrhage
         subjects affected / exposed
    1 / 921 (0.11%)
    0 / 914 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 921 (0.00%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metrorrhagia
         subjects affected / exposed
    1 / 921 (0.11%)
    0 / 914 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine cyst
         subjects affected / exposed
    0 / 921 (0.00%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 921 (0.11%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 921 (0.00%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 921 (0.00%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    6 / 921 (0.65%)
    6 / 914 (0.66%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 921 (0.00%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 921 (0.00%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Paraesthesia
         subjects affected / exposed
    0 / 921 (0.00%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 921 (0.00%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 921 (0.11%)
    0 / 914 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral artery thrombosis
         subjects affected / exposed
    1 / 921 (0.11%)
    0 / 914 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 921 (0.00%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 921 (0.00%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 921 (0.22%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 921 (0.11%)
    0 / 914 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 921 (0.11%)
    0 / 914 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    1 / 921 (0.11%)
    0 / 914 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Chest pain
         subjects affected / exposed
    1 / 921 (0.11%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess neck
         subjects affected / exposed
    0 / 921 (0.00%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Thyroid haemorrhage
         subjects affected / exposed
    1 / 921 (0.11%)
    0 / 914 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Oedema
         subjects affected / exposed
    0 / 921 (0.00%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    2 / 921 (0.22%)
    0 / 914 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 921 (0.00%)
    2 / 914 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    2 / 921 (0.22%)
    0 / 914 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 921 (0.11%)
    0 / 914 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 921 (0.00%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 921 (0.11%)
    0 / 914 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 921 (0.11%)
    0 / 914 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 921 (0.00%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 921 (0.00%)
    1 / 914 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    SMART CBP (Conventional best practice)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 921 (1.52%)
    9 / 914 (0.98%)
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    14 / 921 (1.52%)
    9 / 914 (0.98%)
         occurrences all number
    14
    9

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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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