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    Clinical Trial Results:
    A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD)

    Summary
    EudraCT number
    		 2010-021523-28
    Trial protocol
    		 AT   DK   SE   DE   IT  
    Global end of trial date
    24 May 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 May 2019
    First version publication date
    31 May 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ACP-001 CT-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01247675
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ascendis Pharma A/S
    Sponsor organisation address
    Tuborg Boulevard 12, Hellerup, Denmark, DK 2900
    Public contact
    Michael Beckert, MD, Ascendis Pharma A/S, mb@ascendispharma.com
    Scientific contact
    Michael Beckert, MD, Ascendis Pharma A/S, mb@ascendispharma.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
    24 May 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 May 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    24 May 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to assess the safety and tolerability of ACP-001 under multiple-dose conditions in adult patients with Growth Hormone Deficiency
    Protection of trial subjects
    Institutional review board and independent ethics committee approval as well as signed informed consent from subjects was obtained prior to any trial-specific procedures.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Nov 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
    Sweden: 13
    Country: Number of subjects enrolled
    Germany: 12
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Denmark: 6
    Worldwide total number of subjects
    37
    EEA total number of subjects
    37
    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)
    28
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at 4 reference centers in Sweden, Denmark, Germany and Italy. Subject screening was initiated in October 2010 and the final subject visit was in May 2011.

    Pre-assignment
    Screening details
    		 Prior to randomization, study subjects entered a 14 to 21 day wash out period following cessation of daily growth hormone therapy.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ACP-001, 0.02 mg hGH/kg/wk
    Arm description
    		 Once weekly subcutaneous injection of ACP-001 equivalent to 0.02 mg hGH/kg/week for 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    TransCon hGH
    Investigational medicinal product code
    ACP-001
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    ACP-001 (TransCon hGH) is injected subcutaneously once-a-week using a syringe and 30-gauge needle. The lyophilized drug product is reconstituted with sterile water for injection prior to use.

    Arm title
    		 ACP-001, 0.04 mg hGH/kg/wk
    Arm description
    		 Once weekly subcutaneous injection of ACP-001 equivalent to 0.04 mg hGH/kg/week for 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    TransCon hGH
    Investigational medicinal product code
    ACP-001
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    ACP-001 (TransCon hGH) is injected subcutaneously once-a-week using a syringe and 30-gauge needle. The lyophilized drug product is reconstituted with sterile water for injection prior to use.

    Arm title
    		 ACP-001, 0.08 mg hGH/kg/wk
    Arm description
    		 Once weekly subcutaneous injection of ACP-001 equivalent to 0.08 mg hGH/kg/week for 4 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    TransCon hGH
    Investigational medicinal product code
    ACP-001
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    ACP-001 (TransCon hGH) is injected subcutaneously once-a-week using a syringe and 30-gauge needle. The lyophilized drug product is reconstituted with sterile water for injection prior to use.

    Arm title
    		 Omnitrope, 0.04 mg hGH/kg/wk
    Arm description
    		 Once daily subcutaneous injection of human Growth Hormone (Omnitrope) equivalent to 0.04 mg hGH/kg/week for 4 weeks
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Omnitrope
    Investigational medicinal product code
    Other name
    Human growth hormone
    Pharmaceutical forms
    Solution for injection in cartridge
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Omnitrope is delivered once-daily by subcutaneous injection. The drug product solution is provided in a glass cartridge ready for use in the Omnitrope Pen 5.

    Number of subjects in period 1
    		ACP-001, 0.02 mg hGH/kg/wk ACP-001, 0.04 mg hGH/kg/wk ACP-001, 0.08 mg hGH/kg/wk Omnitrope, 0.04 mg hGH/kg/wk
    Started
    10
    10
    9
    8
    Completed
    8
    8
    9
    8
    Not completed
    2
    2
    0
    0
         Consent withdrawn by subject
    1
    -
    -
    -
         Physician decision
    1
    -
    -
    -
         Adverse event, non-fatal
    -
    2
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ACP-001, 0.02 mg hGH/kg/wk
    Reporting group description
    		 Once weekly subcutaneous injection of ACP-001 equivalent to 0.02 mg hGH/kg/week for 4 weeks

    Reporting group title
    ACP-001, 0.04 mg hGH/kg/wk
    Reporting group description
    		 Once weekly subcutaneous injection of ACP-001 equivalent to 0.04 mg hGH/kg/week for 4 weeks

    Reporting group title
    ACP-001, 0.08 mg hGH/kg/wk
    Reporting group description
    		 Once weekly subcutaneous injection of ACP-001 equivalent to 0.08 mg hGH/kg/week for 4 weeks

    Reporting group title
    Omnitrope, 0.04 mg hGH/kg/wk
    Reporting group description
    		 Once daily subcutaneous injection of human Growth Hormone (Omnitrope) equivalent to 0.04 mg hGH/kg/week for 4 weeks

    Reporting group values
    		 ACP-001, 0.02 mg hGH/kg/wk ACP-001, 0.04 mg hGH/kg/wk ACP-001, 0.08 mg hGH/kg/wk Omnitrope, 0.04 mg hGH/kg/wk Total
    Number of subjects
    		 10 10 9 8 37
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55.7 ± 12.6 45.9 ± 15.0 51.6 ± 18.1 44.0 ± 15.7 -
    Gender categorical
    Units: Subjects
        Female
    		 5 6 5 3 19
        Male
    		 5 4 4 5 18

    End points

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    End points reporting groups
    Reporting group title
    ACP-001, 0.02 mg hGH/kg/wk
    Reporting group description
    		 Once weekly subcutaneous injection of ACP-001 equivalent to 0.02 mg hGH/kg/week for 4 weeks

    Reporting group title
    ACP-001, 0.04 mg hGH/kg/wk
    Reporting group description
    		 Once weekly subcutaneous injection of ACP-001 equivalent to 0.04 mg hGH/kg/week for 4 weeks

    Reporting group title
    ACP-001, 0.08 mg hGH/kg/wk
    Reporting group description
    		 Once weekly subcutaneous injection of ACP-001 equivalent to 0.08 mg hGH/kg/week for 4 weeks

    Reporting group title
    Omnitrope, 0.04 mg hGH/kg/wk
    Reporting group description
    		 Once daily subcutaneous injection of human Growth Hormone (Omnitrope) equivalent to 0.04 mg hGH/kg/week for 4 weeks

    Primary: Number of Subjects Reporting Local Tolerability Events (Assessed by the Patient and Investigator)

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    End point title
    		 Number of Subjects Reporting Local Tolerability Events (Assessed by the Patient and Investigator) [1]
    End point description
    Assessment of local tolerability was performed by examining injection sites by the investigator during study visits, and on the basis of records in the Patient Diary. Assessments included erythema, swelling, or pain.
    End point type
    Primary
    End point timeframe
    Start of study treatment through Week 4
    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: Nine subjects experienced at least one injection site reaction and there was no clear difference in these reactions between ACP-001 and Omnitrope treated subjects.
    End point values
    		 ACP-001, 0.02 mg hGH/kg/wk ACP-001, 0.04 mg hGH/kg/wk ACP-001, 0.08 mg hGH/kg/wk Omnitrope, 0.04 mg hGH/kg/wk
    Number of subjects analysed
    10
    10
    9
    8
    Units: Number of subjects with any symptom
    3
    3
    2
    1
    No statistical analyses for this end point

    Primary: Incidence of Treatment Emergent Anti-hGH Binding Antibody Formation

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    End point title
    		 Incidence of Treatment Emergent Anti-hGH Binding Antibody Formation [2]
    End point description
    Number of subjects with treatment emergent anti-hGH binding antibodies
    End point type
    Primary
    End point timeframe
    Start of study treatment through Day 42
    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: There were no Treatment Emergent anti-hGH binding antibodies in any of the treatment arms.
    End point values
    		 ACP-001, 0.02 mg hGH/kg/wk ACP-001, 0.04 mg hGH/kg/wk ACP-001, 0.08 mg hGH/kg/wk Omnitrope, 0.04 mg hGH/kg/wk
    Number of subjects analysed
    10
    10
    9
    8
    Units: Participants
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Cmax of hGH

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    End point title
    		 Cmax of hGH
    End point description
    As part of the following endpoint: Pharmacokinetic (PK) profile of serum human Growth Hormone (hGH) from ACP-001 treated dose groups compared to the PK profile of hGH from the daily Omnitrope treated group. Cmax (maximum value of concentration) values at Week 4
    End point type
    Secondary
    End point timeframe
    Days 22 to 29
    End point values
    		 ACP-001, 0.02 mg hGH/kg/wk ACP-001, 0.04 mg hGH/kg/wk ACP-001, 0.08 mg hGH/kg/wk Omnitrope, 0.04 mg hGH/kg/wk
    Number of subjects analysed
    10
    8
    9
    8
    Units: ng/mL
        arithmetic mean (standard deviation)
    1.2 ± 0.8
    1.9 ± 0.9
    3.8 ± 2.0
    2.0 ± 1.1
    No statistical analyses for this end point

    Secondary: Emax of IGF-I

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    End point title
    		 Emax of IGF-I
    End point description
    As part of the following endpoint: Pharmacodynamic (PD) response of serum Insulin-like Growth Factor-I (IGF-I) from ACP-001 treated dose groups compared to the PD response of IGF-I from the daily Omnitrope treated group. Emax (maximum observed response) values at Week 4
    End point type
    Secondary
    End point timeframe
    Days 22 to 29
    End point values
    		 ACP-001, 0.02 mg hGH/kg/wk ACP-001, 0.04 mg hGH/kg/wk ACP-001, 0.08 mg hGH/kg/wk Omnitrope, 0.04 mg hGH/kg/wk
    Number of subjects analysed
    10
    8
    9
    8
    Units: ng/mL
        arithmetic mean (standard deviation)
    71.8 ± 26.9
    108.6 ± 91.7
    125.6 ± 70.1
    109.8 ± 37.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Reported Adverse Events include events starting on or after Day 0 and ending on or before Day 42.
    Adverse event reporting additional description
    A subject with more than one finding in a specific category was only counted once.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    ACP-001, 0.02 mg hGH/kg/wk
    Reporting group description
    		 Once weekly subcutaneous injection of ACP-001 equivalent to 0.02 mg hGH/kg/week for 4 weeks

    Reporting group title
    ACP-001, 0.04 mg hGH/kg/wk
    Reporting group description
    		 Once weekly subcutaneous injection of ACP-001 equivalent to 0.04 mg hGH/kg/week for 4 weeks

    Reporting group title
    ACP-001, 0.08 mg hGH/kg/wk
    Reporting group description
    		 Once weekly subcutaneous injection of ACP-001 equivalent to 0.08 mg hGH/kg/week for 4 weeks

    Reporting group title
    Omnitrope, 0.04 mg hGH/kg/wk
    Reporting group description
    		 Once daily subcutaneous injection of human Growth Hormone (Omnitrope) equivalent to 0.04 mg hGH/kg/week for 4 weeks

    Serious adverse events
    		 ACP-001, 0.02 mg hGH/kg/wk ACP-001, 0.04 mg hGH/kg/wk ACP-001, 0.08 mg hGH/kg/wk Omnitrope, 0.04 mg hGH/kg/wk
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Pleuritic Pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Severe Adrenal Crisis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ACP-001, 0.02 mg hGH/kg/wk ACP-001, 0.04 mg hGH/kg/wk ACP-001, 0.08 mg hGH/kg/wk Omnitrope, 0.04 mg hGH/kg/wk
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 10 (60.00%)
    9 / 10 (90.00%)
    7 / 9 (77.78%)
    7 / 8 (87.50%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Headache
         subjects affected / exposed
    2 / 10 (20.00%)
    3 / 10 (30.00%)
    2 / 9 (22.22%)
    2 / 8 (25.00%)
         occurrences all number
    2
    3
    7
    4
    General disorders and administration site conditions
    Application site erythema
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    3
    0
    0
    1
    Application site induration
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    3
    0
    0
    1
    Application site pruritus
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    2
    0
    0
    1
    Asthenia
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Condition aggravated
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    0
    3
    3
    0
    Edema peripheral
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    2
    Fatigue
         subjects affected / exposed
    3 / 10 (30.00%)
    3 / 10 (30.00%)
    1 / 9 (11.11%)
    2 / 8 (25.00%)
         occurrences all number
    8
    4
    4
    12
    Influenza like illness
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 10 (20.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Injection site pain
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    3
    3
    Abdominal pain upper
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 10 (20.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    2
    0
    1
    Dyspepsia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    1
    Nausea
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 10 (30.00%)
    2 / 9 (22.22%)
    1 / 8 (12.50%)
         occurrences all number
    0
    3
    2
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 10 (30.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 10 (10.00%)
    3 / 10 (30.00%)
    2 / 9 (22.22%)
    2 / 8 (25.00%)
         occurrences all number
    1
    4
    2
    2
    Rales
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    2
    0
    0
    1
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Insomnia
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Stress
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    0
    0
    3
    Renal and urinary disorders
    Hematuria
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    0
    0
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    2
    2
    2
    0
    Back pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    2 / 9 (22.22%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Myalgia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    3
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    2 / 9 (22.22%)
    2 / 8 (25.00%)
         occurrences all number
    0
    2
    2
    2
    Pharyngitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    2
    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28196799
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