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    Clinical Trial Results:
    Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)

    Summary
    EudraCT number
    		 2008-000943-33
    Trial protocol
    		 GB  
    Global end of trial date
    23 Jul 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Feb 2016
    First version publication date
    03 Dec 2014
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GRT83
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00718146
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    1541, Avenue Marcel Mérieux, Marcy L’Etoile, France, 69280
    Public contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 (0)4 37 65 66 04, derek.wallace@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 (0)4 37 65 66 04, derek.wallace@sanofipasteur.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
    07 Aug 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jul 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine Northern Hemisphere 2008-2009 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.
    Protection of trial subjects
    Only subjects who met all the study inclusion and none of the exclusion criteria were vaccinated in the study. Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    26 Jun 2008
    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: 130
    Worldwide total number of subjects
    130
    EEA total number of subjects
    130
    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)
    90
    From 65 to 84 years
    40
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study subjects were enrolled from 26 June 2008 to 23 July 2008 in 2 clinical centers in the United Kingdom.

    Pre-assignment
    Screening details
    		 A total of 130 subjects who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 18 to 60 years
    Arm description
    		 Subjects aged 18 to 60 years who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2008-2009 formulation on day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Influenza vaccine (split virion, inactivated)
    Investigational medicinal product code
    314
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, one dose on Day 0.

    Arm title
    		 61 years or older
    Arm description
    		 Subjects aged 61 years or older who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2008-2009 formulation on day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Influenza vaccine (split virion, inactivated)
    Investigational medicinal product code
    314
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, one dose on Day 0.

    Number of subjects in period 1
    		18 to 60 years 61 years or older
    Started
    65
    65
    Completed
    65
    65

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    18 to 60 years
    Reporting group description
    		 Subjects aged 18 to 60 years who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2008-2009 formulation on day 0.

    Reporting group title
    61 years or older
    Reporting group description
    		 Subjects aged 61 years or older who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2008-2009 formulation on day 0.

    Reporting group values
    		 18 to 60 years 61 years or older Total
    Number of subjects
    		 65 65 130
    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)
    		 65 25 90
        From 65-84 years
    		 0 40 40
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.2 ( 14.28 ) 67.5 ( 4.24 ) -
    Gender categorical
    Units: Subjects
        Female
    		 31 32 63
        Male
    		 34 33 67
    Previous influenza vaccination
    Units: Subjects
        Yes
    		 23 47 70
        No
    		 42 18 60
    Previous influenza infection last winter
    Units: Subjects
        Yes
    		 3 1 4
        No
    		 62 64 126

    End points

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    End points reporting groups
    Reporting group title
    18 to 60 years
    Reporting group description
    		 Subjects aged 18 to 60 years who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2008-2009 formulation on day 0.

    Reporting group title
    61 years or older
    Reporting group description
    		 Subjects aged 61 years or older who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2008-2009 formulation on day 0.

    Primary: Summary of Geometric Mean Titers (GMTs) of influenza Vaccine Antibodies Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation by the Intramuscular Route

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    End point title
    		 Summary of Geometric Mean Titers (GMTs) of influenza Vaccine Antibodies Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation by the Intramuscular Route [1]
    End point description
    Influenza vaccine antibodies were assessed using the hemagglutination inhibition technique.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 18 to 60 years 61 years or older
    Number of subjects analysed
    64
    65
    Units: Titers
    geometric mean (confidence interval 95%)
        A/Brisbane/59/2007 like strain (H1N1; Day 0)
    18.1 (13.1 to 25.1)
    26.4 (19.4 to 35.8)
        A/Brisbane/10/2007 like strain (H3N2; Day 0)
    10.8 (8.31 to 14)
    14.2 (10.3 to 19.7)
        B/Florida/4/2006 like strain (B; Day 0)
    13.5 (10.6 to 17.1)
    23.2 (18.2 to 29.7)
        A/Brisbane/59/2007 like strain (H1N1; Day 21)
    311 (235 to 413)
    127 (96.6 to 166)
        A/Brisbane/10/2007 like strain (H3N2; Day 21)
    144 (97.7 to 211)
    104 (73.2 to 149)
        B/Florida/4/2006 like strain (B; Day 21)
    107 (82.4 to 139)
    71.1 (56.5 to 89.7)
    No statistical analyses for this end point

    Primary: Summary of Geometric Mean Titers Ratios (GMTR) of influenza Vaccine Antibodies After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation by the Intramuscular Route

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    End point title
    		 Summary of Geometric Mean Titers Ratios (GMTR) of influenza Vaccine Antibodies After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation by the Intramuscular Route [2]
    End point description
    Influenza vaccine antibodies were assessed using the hemagglutination inhibition technique. Geometric mean titer ratio is the geometric mean of the individual post-vaccination/pre-vaccination titer of antibodies to the influenza virus antigens.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post vaccination
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 18 to 60 years 61 years or older
    Number of subjects analysed
    64
    65
    Units: Titer ratios
    geometric mean (confidence interval 95%)
        A/Brisbane/59/2007 like strain (H1N1)
    17.2 (11.9 to 24.9)
    4.8 (3.4 to 6.77)
        A/Brisbane/10/2007 like strain (H3N2)
    13.3 (9.11 to 19.5)
    7.35 (5.23 to 10.3)
        B/Florida/4/2006 like strain (B)
    7.96 (5.65 to 11.2)
    3.06 (2.36 to 3.98)
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Seroprotection Against the Influenza Vaccine Antigens Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation by the Intramuscular Route

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    End point title
    		 Percentage of Subjects with Seroprotection Against the Influenza Vaccine Antigens Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation by the Intramuscular Route [3]
    End point description
    Influenza vaccine antibodies were assessed using the hemagglutination inhibition technique. Seroprotection was defined as titers ≥40 (1/dil) on Day 0 and Day 21.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post vaccination
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 18 to 60 years 61 years or older
    Number of subjects analysed
    64
    65
    Units: Percentage of subjects
    number (not applicable)
        A/Brisbane/59/2007 like strain (H1N1; Day 0)
    28.1
    40
        A/Brisbane/10/2007 like strain (H3N2; Day 0)
    17.2
    26.2
        B/Florida/4/2006 like strain (B; Day 0)
    20.3
    33.8
        A/Brisbane/59/2007 like strain (H1N1; Day 21)
    96.9
    87.7
        A/Brisbane/10/2007 like strain (H3N2; Day 21)
    81.3
    81.5
        B/Florida/4/2006 like strain (B; Day 21)
    89.1
    80
    No statistical analyses for this end point

    Primary: Percentage of Subjects Achieving Seroconversion or Significant Increase Against the Influenza Vaccine Antigens Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation by Intramuscular Route

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    End point title
    		 Percentage of Subjects Achieving Seroconversion or Significant Increase Against the Influenza Vaccine Antigens Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation by Intramuscular Route [4]
    End point description
    Influenza vaccine antibodies were assessed using the hemagglutination inhibition technique. Seroconversion was defined as subjects with a titer <10 (1/dil) on Day 0 and a post-injection titer ≥40 (1/dil) on Day 21 or significant increase was defined as subjects with a titer ≥10 (1/dil) on Day 0 and a ≥4-fold increase of post-injection titer on Day 21.
    End point type
    Primary
    End point timeframe
    Day 21 post vaccination
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 18 to 60 years 61 years or older
    Number of subjects analysed
    64
    65
    Units: Percentage of Subjects
    number (not applicable)
        A/Brisbane/59/2007 like strain (H1N1)
    79.7
    47.7
        A/Brisbane/10/2007 like strain (H3N2)
    71.9
    60
        B/Florida/4/2006 like strain (B)
    64.1
    27.7
    No statistical analyses for this end point

    Primary: Percentage of Subjects with at Least One Reaction Corresponding to those Listed in the EMEA Note for Guidance Within 3 Days After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)

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    End point title
    		 Percentage of Subjects with at Least One Reaction Corresponding to those Listed in the EMEA Note for Guidance Within 3 Days After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route) [5]
    End point description
    Solicited injection site reactions: Induration and Ecchymosis. Solicited systemic reactions: Pyrexia, Malaise, and Shivering.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 3 post-vaccination
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 18 to 60 years 61 years or older
    Number of subjects analysed
    65
    65
    Units: Percentage of subjects
    number (not applicable)
        Injection site induration ≥5 cm for 4 days
    0
    0
        Injection site ecchymosis
    7.7
    6.2
        Pyrexia (>38°C for at least 1 day)
    1.5
    0
        Malaise
    12.3
    9.2
        Shivering
    3.1
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Solicited Injection-site or Systemic Reactions within 3 Days After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation by the Intramuscular Route

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    End point title
    		 Percentage of Subjects Reporting Solicited Injection-site or Systemic Reactions within 3 Days After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation by the Intramuscular Route [6]
    End point description
    Solicited injection site: Pain, Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain – Incapacitating, unable to perform usual activities; Erythema, Swelling, Induration, and Ecchymosis – ≥10 cm. Grade 3 systemic reactions: Fever – >39.0°C; Headache, Malaise, Myalgia, and Shivering – Prevents daily activity.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 3 post-vaccination
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 18 to 60 years 61 years or older
    Number of subjects analysed
    65
    65
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    49.2
    24.6
        Grade 3 Injection site Pain
    0
    0
        Injection site Erythema
    32.3
    27.7
        Grade 3 Injection site Erythema
    3.1
    9.2
        Injection site Swelling
    18.5
    12.3
        Grade 3 Injection site Swelling
    0
    0
        Injection site Induration
    27.7
    12.3
        Grade 3 Injection site Induration
    1.5
    0
        Injection site Ecchymosis
    7.7
    6.2
        Grade 3 Injection site Ecchymosis
    0
    0
        Fever
    10.8
    4.6
        Grade 3 Fever
    0
    0
        Headache
    20
    13.8
        Grade 3 Headache
    1.5
    0
        Malaise
    12.3
    9.2
        Grade 3 Malaise
    0
    0
        Myalgia
    15.4
    15.4
        Grade 3 Myalgia
    0
    0
        Shivering
    3.1
    0
        Grade 3 Shivering
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Solicited Injection-site or Systemic Reactions More than 3 Days After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation by the Intramuscular Route

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    End point title
    		 Percentage of Subjects Reporting Solicited Injection-site or Systemic Reactions More than 3 Days After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation by the Intramuscular Route [7]
    End point description
    Solicited injection site: Pain, Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain – Incapacitating, unable to perform usual activities; Erythema, Swelling, Induration, and Ecchymosis – ≥10 cm. Grade 3 systemic reactions: Fever – >39.0°C; Headache, Malaise, Myalgia, and Shivering – Prevents daily activity.
    End point type
    Primary
    End point timeframe
    >Day 3 post-vaccination
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 18 to 60 years 61 years or older
    Number of subjects analysed
    65
    65
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    49.2
    24.6
        Grade 3 Injection site Pain
    0
    0
        Injection site Erythema
    32.3
    27.7
        Grade 3 Injection site Erythema
    3.1
    9.2
        Injection site Swelling
    18.5
    12.3
        Grade 3 Injection site Swelling
    0
    0
        Injection site Induration
    27.7
    12.3
        Grade 3 Injection site Induration
    1.5
    0
        Injection site Ecchymosis
    7.7
    6.2
        Grade 3 Injection site Ecchymosis
    0
    0
        Fever
    0
    0
        Grade 3 Fever
    0
    0
        Headache
    1.5
    4.6
        Grade 3 Headache
    0
    0
        Malaise
    1.5
    3.1
        Grade 3 Malaise
    0
    0
        Myalgia
    3.1
    3.1
        Grade 3 Myalgia
    1.5
    0
        Shivering
    0
    0
        Grade 3 Shivering
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    18 to 60 years
    Reporting group description
    		 Subjects aged 18 to 60 years who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2008-2009 formulation on day 0.

    Reporting group title
    61 years or older
    Reporting group description
    		 Subjects aged 61 years or older who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2008-2009 formulation on day 0.

    Serious adverse events
    		 18 to 60 years 61 years or older
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 65 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 18 to 60 years 61 years or older
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 65 (49.23%)
    18 / 65 (27.69%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    13 / 65 (20.00%)
    9 / 65 (13.85%)
         occurrences all number
    13
    9
    General disorders and administration site conditions
    Injection site ecchymosis
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 65 (7.69%)
    4 / 65 (6.15%)
         occurrences all number
    5
    4
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 65 (12.31%)
    6 / 65 (9.23%)
         occurrences all number
    8
    6
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed
    32 / 65 (49.23%)
    16 / 65 (24.62%)
         occurrences all number
    32
    16
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    21 / 65 (32.31%)
    18 / 65 (27.69%)
         occurrences all number
    21
    18
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    12 / 65 (18.46%)
    8 / 65 (12.31%)
         occurrences all number
    12
    8
    Injection site induration
    alternative assessment type: Systematic
         subjects affected / exposed
    18 / 65 (27.69%)
    8 / 65 (12.31%)
         occurrences all number
    18
    8
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 65 (10.77%)
    3 / 65 (4.62%)
         occurrences all number
    7
    3
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    10 / 65 (15.38%)
    10 / 65 (15.38%)
         occurrences all number
    10
    10

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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