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    Clinical Trial Results:
    A Phase 2, randomized, blinded, 5-period cross-over, placebo and active-controlled, multicenter, dose-finding study of single doses of formoterol 2.25 μg, 4.5 μg, and 9 μg delivered via Symbicort pMDI and Foradil® Aerolizer® 12 μg evaluating the bronchodilating effects and safety in children, ages 6 to <12 years, with asthma who are receiving background treatment with budesonide pMDI 160 μg bid

    Summary
    EudraCT number
    		 2010-018316-32
    Trial protocol
    		 HU  
    Global end of trial date
    16 Oct 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Feb 2017
    First version publication date
    07 Aug 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D589GC00002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    AstraZeneca R&D, 431 83 Mölndal, Sweden,
    Public contact
    Göran Eckerwall, MSD, AstraZeneca, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    Göran Eckerwall, MSD, AstraZeneca, ClinicalTrialTransparency@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
    16 Oct 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Oct 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Oct 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the bronchodilating effects of 3 doses of formoterol given in combination with budesonide as Symbicort pMDI in a population of asthmatic children demonstrated to be stable on a medium dose range of ICS therapy.
    Protection of trial subjects
    An Ethics Committee (EC)/Institutional Review Board (IRB) approved the final clinical study protocol (CSP), including the final version of the Informed Consent Form (ICF) and any other written information, to be provided to the patients. The principal investigator at each center ensured that both the patient (assent) and the parent or legal guardian (consent) were given full and adequate oral and written information about the nature, purpose, possible risk and benefit of the study. Patients were notified that they were free to withdraw from the study at any time. The patient was given the opportunity to ask questions and allowed time to consider the information provided. The patient’s signed and dated informed assent and the parent or legal guardian’s consent were obtained and documented before conducting any study procedures.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Oct 2010
    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 States: 54
    Worldwide total number of subjects
    54
    EEA total number of subjects
    0
    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)
    54
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This multicenter study was conducted in the United States between 7 October 2010 and 3 January 2012. This was a 5-way cross-over study comparing single doses of 2.25 μg, 4.5 μg, and 9 μg of inhaled formoterol given as Symbicort pMDI and Foradil Aerolizer 12 μg dry powder inhaler with placebo, given in combination with budesonide pMDI 160 μg.

    Pre-assignment
    Screening details
    		 The study consisted of a screening visit, an enrolment visit, a 1- to 2-week run-in period, randomization at Visit 3, and 4 further visits (Visits 4-7)separated by approximately 7-day wash-out periods. Subjects received 1 of 5 single-dose treatments at Visits 3-7, in random order.

    Period 1
    Period 1 title
    BUD 160/FM 2.25
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Carer, Assessor, Subject

    Arms
    Arm title
    		 BUD 160/FM 2.25
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    BUD 160/FM 2.25
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI

    Number of subjects in period 1
    		BUD 160/FM 2.25
    Started
    54
    Completed
    54
    Period 2
    Period 2 title
    BUD 160/FM 2.25 Washout
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 BUD 160/FM 2.25 Washout
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		BUD 160/FM 2.25 Washout
    Started
    54
    Completed
    53
    Not completed
    1
         Consent withdrawn by subject
    1
    Period 3
    Period 3 title
    BUD 160/FM 4.5
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Arm title
    		 BUD 160/FM 4.5
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    BUD 160/FM 4.5
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol

    Number of subjects in period 3
    		BUD 160/FM 4.5
    Started
    53
    Completed
    53
    Period 4
    Period 4 title
    BUD 160/FM 4.5 Washout
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 BUD 160/FM 4.5 Washout
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 4
    		BUD 160/FM 4.5 Washout
    Started
    53
    Completed
    53
    Period 5
    Period 5 title
    BUD 160/FM 9.0
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Arm title
    		 BUD 160/FM 9.0
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    BUD 160/FM 9.0
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    placebo HFA pMDI x 1 inhalation + 9 μg formoterol

    Number of subjects in period 5
    		BUD 160/FM 9.0
    Started
    53
    Completed
    53
    Period 6
    Period 6 title
    BUD 160/FM 9.0 Washout
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 BUD 160/FM 9.0 Washout
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 6
    		BUD 160/FM 9.0 Washout
    Started
    53
    Completed
    51
    Not completed
    2
         Consent withdrawn by subject
    1
         Adverse event, non-fatal
    1
    Period 7
    Period 7 title
    BUD 160
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Arm title
    		 BUD 160
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    BUD 160
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    placebo HFA pMDI x 1 inhalation + 80 μg budesonide HFA pMDI

    Number of subjects in period 7
    		BUD 160
    Started
    51
    Completed
    51
    Period 8
    Period 8 title
    BUD 160 Washout
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 BUD 160 Washout
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 8
    		BUD 160 Washout
    Started
    51
    Completed
    51
    Period 9
    Period 9 title
    BUD 160/Foradil 12.0
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Arm title
    		 BUD 160/Foradil 12.0
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    BUD 160/Foradil 12.0
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Foradil Aerolizer 12 μg x 1 inhalation + 80 μg

    Number of subjects in period 9
    		BUD 160/Foradil 12.0
    Started
    51
    Completed
    51
    Period 10
    Period 10 title
    BUD 160/Foradil 12.0 Washout
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 BUD 160/Foradil 12.0 Washout
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 10
    		BUD 160/Foradil 12.0 Washout
    Started
    51
    Completed
    50
    Not completed
    1
         Adverse event, non-fatal
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BUD 160/FM 2.25
    Reporting group description
    		 -

    Reporting group values
    		 BUD 160/FM 2.25 Total
    Number of subjects
    		 54 54
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 54 54
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age Continuous |
    Units: years
        arithmetic mean (full range (min-max))
    		 9.2 (6 to 11) -
    Gender, Male/Female
    Units: participants
        Female
    		 23 23
        Male
    		 31 31
    Age group
    Units: Subjects
        >=6 to <8
    		 11 11
        >=8 to <12
    		 43 43
    Months since Diagnosis
    Units: months
        arithmetic mean (standard deviation)
    		 73.2 ± 39.16 -

    End points

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    End points reporting groups
    Reporting group title
    BUD 160/FM 2.25
    Reporting group description
    		 -
    Reporting group title
    BUD 160/FM 2.25 Washout
    Reporting group description
    		 -
    Reporting group title
    BUD 160/FM 4.5
    Reporting group description
    		 -
    Reporting group title
    BUD 160/FM 4.5 Washout
    Reporting group description
    		 -
    Reporting group title
    BUD 160/FM 9.0
    Reporting group description
    		 -
    Reporting group title
    BUD 160/FM 9.0 Washout
    Reporting group description
    		 -
    Reporting group title
    BUD 160
    Reporting group description
    		 -
    Reporting group title
    BUD 160 Washout
    Reporting group description
    		 -
    Reporting group title
    BUD 160/Foradil 12.0
    Reporting group description
    		 -
    Reporting group title
    BUD 160/Foradil 12.0 Washout
    Reporting group description
    		 -

    Primary: Average 12 hour forced expiratory volume in 1 second (FEV1)

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    End point title
    		 Average 12 hour forced expiratory volume in 1 second (FEV1)
    End point description
    Pulmonary function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 was obtained from the full expiratory flow-volume-time curve. FEV1 was measured at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes post administration of randomized study medication. Twelve-hour serial FEV1 was calculated through an AUC determination and then divided by time, so that the final value is expressed in liters. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0. LOCF imputation method used.
    End point type
    Primary
    End point timeframe
    at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes postdose
    End point values
    		 BUD 160/FM 2.25 BUD 160/FM 4.5 BUD 160/FM 9.0 BUD 160 BUD 160/Foradil 12.0
    Number of subjects analysed
    54
    53
    53
    51
    51
    Units: liters
        least squares mean (standard error)
    1.546 ± 0.0097
    1.594 ± 0.0099
    1.603 ± 0.0099
    1.489 ± 0.0101
    1.603 ± 0.0101
    Statistical analysis title
    		 Average 12-hour FEV1
    Statistical analysis description
    Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit. LOCF imputation method used.
    Comparison groups
    BUD 160/FM 9.0 v BUD 160
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.114
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.087
         upper limit
    		 0.142
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.014
    Statistical analysis title
    		 Average 12-hour FEV1
    Statistical analysis description
    Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit. LOCF imputation method used.
    Comparison groups
    BUD 160/FM 4.5 v BUD 160
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.105
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.078
         upper limit
    		 0.133
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.014
    Statistical analysis title
    		 Average 12-hour FEV1
    Statistical analysis description
    Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit. LOCF imputation method used.
    Comparison groups
    BUD 160/FM 2.25 v BUD 160
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.058
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.03
         upper limit
    		 0.085
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0141
    Statistical analysis title
    		 Average 12-hour FEV1
    Statistical analysis description
    Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit. LOCF imputation method used.
    Comparison groups
    BUD 160/FM 4.5 v BUD 160/FM 9.0
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5223
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.009
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.036
         upper limit
    		 0.018
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0139
    Statistical analysis title
    		 Average 12-hour FEV1
    Statistical analysis description
    Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit. LOCF imputation method used.
    Comparison groups
    BUD 160/FM 2.25 v BUD 160/FM 9.0
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.057
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.084
         upper limit
    		 -0.029
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0139
    Statistical analysis title
    		 Average 12-hour FEV1
    Statistical analysis description
    Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit. LOCF imputation method used.
    Comparison groups
    BUD 160/FM 2.25 v BUD 160/FM 4.5
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0007
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.048
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.075
         upper limit
    		 -0.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0138
    Statistical analysis title
    		 Average 12-hour FEV1
    Statistical analysis description
    Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit. LOCF imputation method used.
    Comparison groups
    BUD 160 v BUD 160/Foradil 12.0
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.114
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.142
         upper limit
    		 -0.086
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0141
    Statistical analysis title
    		 Average 12-hour FEV1
    Statistical analysis description
    Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit. LOCF imputation method used.
    Comparison groups
    BUD 160/FM 2.25 v BUD 160/Foradil 12.0
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.056
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.084
         upper limit
    		 -0.028
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0141
    Statistical analysis title
    		 Average 12-hour FEV1
    Statistical analysis description
    Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit. LOCF imputation method used.
    Comparison groups
    BUD 160/FM 4.5 v BUD 160/Foradil 12.0
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5394
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.009
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.036
         upper limit
    		 0.019
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0141
    Statistical analysis title
    		 Average 12-hour FEV1
    Statistical analysis description
    Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit. LOCF imputation method used.
    Comparison groups
    BUD 160/FM 9.0 v BUD 160/Foradil 12.0
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9863
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.027
         upper limit
    		 0.028
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.014

    Secondary: FEV1 at 12 hours after study medication inhalation

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    End point title
    		 FEV1 at 12 hours after study medication inhalation
    End point description
    Pulmonary function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. The FEV1 value at 12 hours after dosing was taken as the 12-hour measurement (720 minutes) from the serial spirometry. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0. LOCF imputation method used.
    End point type
    Secondary
    End point timeframe
    12 hours after dosing
    End point values
    		 BUD 160/FM 2.25 BUD 160/FM 4.5 BUD 160/FM 9.0 BUD 160 BUD 160/Foradil 12.0
    Number of subjects analysed
    54
    53
    53
    51
    51
    Units: liters
        least squares mean (standard error)
    1.641 ± 0.0175
    1.692 ± 0.0177
    1.731 ± 0.0177
    1.626 ± 0.0181
    1.709 ± 0.0182
    Statistical analysis title
    		 FEV1 at 12 hours after study medication
    Statistical analysis description
    Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit. LOCF imputation method used.
    Comparison groups
    BUD 160/FM 9.0 v BUD 160
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.105
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.056
         upper limit
    		 0.155
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.025
    Statistical analysis title
    		 FEV1 at 12 hours after study medication
    Statistical analysis description
    Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit. LOCF imputation method used.
    Comparison groups
    BUD 160/FM 4.5 v BUD 160
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0092
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.066
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.017
         upper limit
    		 0.116
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0252
    Statistical analysis title
    		 FEV1 at 12 hours after study medication
    Statistical analysis description
    Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit. LOCF imputation method used.
    Comparison groups
    BUD 160/FM 2.25 v BUD 160
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5509
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.015
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.035
         upper limit
    		 0.065
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0252
    Statistical analysis title
    		 FEV1 at 12 hours after study medication
    Statistical analysis description
    Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit. LOCF imputation method used.
    Comparison groups
    BUD 160/FM 4.5 v BUD 160/FM 9.0
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1163
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.039
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.088
         upper limit
    		 0.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0249
    Statistical analysis title
    		 FEV1 at 12 hours after study medication
    Statistical analysis description
    Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit. LOCF imputation method used.
    Comparison groups
    BUD 160/FM 2.25 v BUD 160/FM 9.0
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0004
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.14
         upper limit
    		 -0.041
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.025
    Statistical analysis title
    		 FEV1 at 12 hours after study medication
    Statistical analysis description
    Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit. LOCF imputation method used.
    Comparison groups
    BUD 160/FM 2.25 v BUD 160/FM 4.5
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.04
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.051
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 -0.002
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0247
    Statistical analysis title
    		 FEV1 at 12 hours after study medication
    Statistical analysis description
    Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit. LOCF imputation method used.
    Comparison groups
    BUD 160 v BUD 160/Foradil 12.0
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0011
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.083
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.133
         upper limit
    		 -0.034
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0252
    Statistical analysis title
    		 FEV1 at 12 hours after study medication
    Statistical analysis description
    Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit. LOCF imputation method used.
    Comparison groups
    BUD 160/FM 2.25 v BUD 160/Foradil 12.0
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0077
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.068
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.118
         upper limit
    		 -0.018
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0254
    Statistical analysis title
    		 FEV1 at 12 hours after study medication
    Statistical analysis description
    Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit. LOCF imputation method used.
    Comparison groups
    BUD 160/FM 4.5 v BUD 160/Foradil 12.0
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4957
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.017
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.067
         upper limit
    		 0.033
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0252
    Statistical analysis title
    		 FEV1 at 12 hours after study medication
    Statistical analysis description
    Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit. LOCF imputation method used.
    Comparison groups
    BUD 160/FM 9.0 v BUD 160/Foradil 12.0
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.38
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.022
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.027
         upper limit
    		 0.071
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.025

    Secondary: Maximal FEV1 during the 12-hour study period

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    End point title
    		 Maximal FEV1 during the 12-hour study period
    End point description
    Pulmonary function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 was measured at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes post administration of randomized study medication. The maximum FEV1 value was defined as the largest observed FEV1 value recorded during each 12-hour serial spirometry procedure. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.
    End point type
    Secondary
    End point timeframe
    at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes postdose
    End point values
    		 BUD 160/FM 2.25 BUD 160/FM 4.5 BUD 160/FM 9.0 BUD 160 BUD 160/Foradil 12.0
    Number of subjects analysed
    54
    53
    53
    51
    51
    Units: liters
        least squares mean (standard error)
    1.833 ± 0.0119
    1.889 ± 0.012
    1.884 ± 0.012
    1.777 ± 0.0123
    1.892 ± 0.0123
    Statistical analysis title
    		 Maximal FEV1 during the 12-hour study period
    Statistical analysis description
    Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.
    Comparison groups
    BUD 160/FM 9.0 v BUD 160
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.107
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.073
         upper limit
    		 0.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.017
    Statistical analysis title
    		 Maximal FEV1 during the 12-hour study period
    Statistical analysis description
    Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.
    Comparison groups
    BUD 160/FM 4.5 v BUD 160
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.112
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.078
         upper limit
    		 0.146
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0171
    Statistical analysis title
    		 Maximal FEV1 during the 12-hour study period
    Statistical analysis description
    Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.
    Comparison groups
    BUD 160/FM 2.25 v BUD 160
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0011
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.057
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.023
         upper limit
    		 0.09
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0172
    Statistical analysis title
    		 Maximal FEV1 during the 12-hour study period
    Statistical analysis description
    Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.
    Comparison groups
    BUD 160/FM 4.5 v BUD 160/FM 9.0
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7589
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.005
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.028
         upper limit
    		 0.039
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0169
    Statistical analysis title
    		 Maximal FEV1 during the 12-hour study period
    Statistical analysis description
    Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.
    Comparison groups
    BUD 160/FM 2.25 v BUD 160/FM 9.0
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0035
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.084
         upper limit
    		 -0.017
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.017
    Statistical analysis title
    		 Maximal FEV1 during the 12-hour study period
    Statistical analysis description
    Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.
    Comparison groups
    BUD 160/FM 2.25 v BUD 160/FM 4.5
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0011
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.055
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.089
         upper limit
    		 -0.022
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0168
    Statistical analysis title
    		 Maximal FEV1 during the 12-hour study period
    Statistical analysis description
    Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.
    Comparison groups
    BUD 160 v BUD 160/Foradil 12.0
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.115
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.149
         upper limit
    		 -0.081
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0171
    Statistical analysis title
    		 Maximal FEV1 during the 12-hour study period
    Statistical analysis description
    Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.
    Comparison groups
    BUD 160/FM 2.25 v BUD 160/Foradil 12.0
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0008
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.058
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.092
         upper limit
    		 -0.024
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0172
    Statistical analysis title
    		 Maximal FEV1 during the 12-hour study period
    Statistical analysis description
    Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.
    Comparison groups
    BUD 160/FM 4.5 v BUD 160/Foradil 12.0
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8582
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.003
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.037
         upper limit
    		 0.031
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0172
    Statistical analysis title
    		 Maximal FEV1 during the 12-hour study period
    Statistical analysis description
    Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.
    Comparison groups
    BUD 160/FM 9.0 v BUD 160/Foradil 12.0
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6276
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.008
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.042
         upper limit
    		 0.025
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.017

    Secondary: Urinary excretion of formoterol during the 12 hours following inhalation of study drug

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    End point title
    		 Urinary excretion of formoterol during the 12 hours following inhalation of study drug
    End point description
    The amount of formoterol excreted unchanged in urine over the 12-hour period after administration [Ae(0-12h)] was calculated from the concentration of formoterol in urine multiplied by the total volume of urine collected. Volume was determined from the weight of the collected urine times an assumed urine density of 1020 g/L. The data for six patients who did not have measurable formoterol in their urine on the Foradil 12 μg treatment day was excluded from the analysis. All other urine concentrations below the lower limit of quantification were set to zero. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.
    End point type
    Secondary
    End point timeframe
    0 to 12 hours
    End point values
    		 BUD 160/FM 2.25 BUD 160/FM 4.5 BUD 160/FM 9.0 BUD 160/Foradil 12.0
    Number of subjects analysed
    51
    52
    51
    43
    Units: pmol
        arithmetic mean (standard deviation)
    278.39 ± 204.52
    532.65 ± 416.762
    1090.88 ± 681.941
    980.47 ± 789.274
    Statistical analysis title
    		 Amount of urinary excretion of formoterol
    Statistical analysis description
    Factors in the ANOVA model included: patient, period and treatment.
    Comparison groups
    BUD 160/FM 2.25 v BUD 160/FM 4.5
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.393
         upper limit
    		 0.7
    Statistical analysis title
    		 Urinary excretion of formoterol
    Statistical analysis description
    Factors in the ANOVA model included: patient, period and treatment.
    Comparison groups
    BUD 160/FM 2.25 v BUD 160/FM 9.0
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.194
         upper limit
    		 0.347
    Statistical analysis title
    		 Urinary excretion of formoterol
    Statistical analysis description
    Factors in the ANOVA model included: patient, period and treatment.
    Comparison groups
    BUD 160/FM 2.25 v BUD 160/Foradil 12.0
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.214
         upper limit
    		 0.396
    Statistical analysis title
    		 Urinary excretion of formoterol
    Statistical analysis description
    Factors in the ANOVA model included: patient, period and treatment.
    Comparison groups
    BUD 160/FM 4.5 v BUD 160/FM 9.0
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.371
         upper limit
    		 0.659
    Statistical analysis title
    		 Urinary excretion of formoterol
    Statistical analysis description
    Factors in the ANOVA model included: patient, period and treatment.
    Comparison groups
    BUD 160/FM 9.0 v BUD 160/Foradil 12.0
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4512
    Method
    		 ANOVA
    Parameter type
    		 LS mean difference
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.827
         upper limit
    		 1.528
    Statistical analysis title
    		 Urinary excretion of formoterol
    Statistical analysis description
    Factors in the ANOVA model included: patient, period and treatment.
    Comparison groups
    BUD 160/FM 4.5 v BUD 160/Foradil 12.0
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0002
    Method
    		 ANOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.409
         upper limit
    		 0.755

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected from the enrollment visit until visit 7(5 weeks after randomization). AEs occuring on or after the first dose of medication are included in the summaries below.
    Adverse event reporting additional description
    One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0. A total of 13 patients reported non-serious AEs.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    BUD 160/FM 2.25
    Reporting group description
    		 2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations

    Reporting group title
    BUD 160/FM 4.5
    Reporting group description
    		 placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)

    Reporting group title
    BUD 160
    Reporting group description
    		 placebo HFA pMDI x 1 inhalation + 80 μg budesonide HFA pMDI x 2 inhalations

    Reporting group title
    BUD 160/ Foradil 12.0
    Reporting group description
    		 Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations

    Reporting group title
    BUD 160/FM 9.0
    Reporting group description
    		 placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)

    Serious adverse events
    		 BUD 160/FM 2.25 BUD 160/FM 4.5 BUD 160 BUD 160/ Foradil 12.0 BUD 160/FM 9.0
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 53 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BUD 160/FM 2.25 BUD 160/FM 4.5 BUD 160 BUD 160/ Foradil 12.0 BUD 160/FM 9.0
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 53 (1.89%)
    2 / 51 (3.92%)
    1 / 50 (2.00%)
    5 / 53 (9.43%)
    Nervous system disorders
    Headache
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 53 (1.89%)
    2 / 51 (3.92%)
    0 / 50 (0.00%)
    5 / 53 (9.43%)
         occurrences all number
    1
    2
    4
    0
    5
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    2
    0
    1
    1

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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