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    Clinical Trial Results:
    A Prospective, Multicenter, Open-label, Phase 3b Study of Human Plasma-Derived Factor XIII Concentrate in Subjects with Congenital Factor XIII Deficiency Estudio prospectivo, multicéntrico, con etiqueta abierta, en fase 3b, del concentrado de factor XIII derivado del plasma humano en sujetos con deficiencia congénita de factor XIII

    Summary
    EudraCT number
    		 2009-010722-19
    Trial protocol
    		 ES  
    Global end of trial date
    27 Apr 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jul 2016
    First version publication date
    06 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BI71023_3001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00885742
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CSL Behring LLC
    Sponsor organisation address
    1020 First Avenue, King of Prussia, United States, 19406-0901
    Public contact
    Clinical Trial Disclosure Manager, CSL Behring, clinicaltrials@cslbehring.com
    Scientific contact
    Clinical Trial Disclosure Manager, CSL Behring, clinicaltrials@cslbehring.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Aug 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Apr 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to collect and evaluate observational long term efficacy data of Factor XIII Concentrate (Human) with regard to the frequency and severity of bleeding episodes in subjects with congenital Factor XIII deficiency.
    Protection of trial subjects
    This study was carried out in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice guidelines, and standard operating procedures for clinical research and development at CSL Behring (CSLB). The study protocol and all amendments were approved by the Independent Ethics Committee(s) (IECs) / Institutional Review Board(s) (IRBs) of the participating centers. Before undergoing screening procedures for possible enrollment into the study, subjects were informed, in an understandable form, about the nature, scope, and possible consequences of the study. The investigator was responsible for obtaining a subject’s written informed consent to participate in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Aug 2009
    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
    Spain: 3
    Country: Number of subjects enrolled
    United States: 38
    Worldwide total number of subjects
    41
    EEA total number of subjects
    3
    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)
    2
    Children (2-11 years)
    8
    Adolescents (12-17 years)
    8
    Adults (18-64 years)
    23
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects who completed the PK dosing study (Study BI71023_2002) were offered participation in this study. Participation was also offered to subjects not enrolled in the PK dosing study or who were enrolled in a clinical study being conducted under a separate investigator initiated Investigational new drug (IND) application (BB-IND 5986).

    Pre-assignment
    Screening details
    		 A 4-week screening period preceded the 12-month treatment phase. Forty one subjects were enrolled and received at least 1 dose of Factor XIII (FXIII) Concentrate (Human).

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

    Arms
    Arm title
    		 Factor XIII
    Arm description
    		 Initially, subjects received Factor XIII Concentrate (Human) at a dose of 40 U/kg by intravenous (IV) infusion. Subsequent doses were guided by the individual subject’s Factor XIII activity levels, with the objective of dosing every 28 days (4 weeks) to maintain a Factor XIII activity trough level of approximately 5 to 20%. Subjects remained in the study for up to approximately 1 year.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Factor XIII Concentrate (Human)
    Investigational medicinal product code
    B17023
    Other name
    Fibrogammin® P, Cluvot®
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Initially, subjects who were not enrolled in the PK study received Factor XIII Concentrate (Human) at a dose of 40 U/kg by IV infusion. Subsequent doses were guided by the individual subject’s Factor XIII activity levels, with the objective of dosing every 28 days (4 weeks) to maintain a Factor XIII activity trough level of approximately 5 to 20%. Subjects were administered the dose of Factor XIII Concentrate (Human) as a bolus IV injection at a rate of approximately 250 U/minute.

    Number of subjects in period 1
    		Factor XIII
    Started
    41
    Completed
    41

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Factor XIII
    Reporting group description
    		 Initially, subjects received Factor XIII Concentrate (Human) at a dose of 40 U/kg by intravenous (IV) infusion. Subsequent doses were guided by the individual subject’s Factor XIII activity levels, with the objective of dosing every 28 days (4 weeks) to maintain a Factor XIII activity trough level of approximately 5 to 20%. Subjects remained in the study for up to approximately 1 year.

    Reporting group values
    		 Factor XIII Total
    Number of subjects
    		 41 41
    Age categorical
    Units: Subjects
        < 16 years
    		 18 18
        16 to < 65 years
    		 23 23
        ≥ 65 years
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 20.1 ± 11.2 -
    Gender categorical
    Units: Subjects
        Female
    		 16 16
        Male
    		 25 25

    End points

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    End points reporting groups
    Reporting group title
    Factor XIII
    Reporting group description
    		 Initially, subjects received Factor XIII Concentrate (Human) at a dose of 40 U/kg by intravenous (IV) infusion. Subsequent doses were guided by the individual subject’s Factor XIII activity levels, with the objective of dosing every 28 days (4 weeks) to maintain a Factor XIII activity trough level of approximately 5 to 20%. Subjects remained in the study for up to approximately 1 year.

    Primary: Incidence of Spontaneous Bleeding Events Requiring Treatment

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    End point title
    		 Incidence of Spontaneous Bleeding Events Requiring Treatment [1]
    End point description
    The number of subjects requiring treatment with a Factor XIII-containing product to treat a spontaneous bleeding event. Treatment is defined as administration of a Factor XIII-containing product to treat the bleeding event (e.g. FXIII concentrate, plasma or cryoprecipitate).
    End point type
    Primary
    End point timeframe
    Up to 52 weeks
    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: No participants with a spontaneous bleeding episode required treatment with a FXIII-containing product, hence analysis of incidence could not be performed.
    End point values
    		 Factor XIII
    Number of subjects analysed
    41
    Units: participants
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with spontaneous or traumatic bleeding episodes requiring treatment

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    End point title
    		 Number of Participants with spontaneous or traumatic bleeding episodes requiring treatment
    End point description
    The number of participants with spontaneous or traumatic bleeding episodes (including exercise-induced bleeding episodes) requiring treatment. Treatment is defined as administration of a Factor XIII-containing product to treat the bleeding event (e.g. FXIII concentrate, plasma or cryoprecipitate).
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Factor XIII
    Number of subjects analysed
    41
    Units: participants
    2
    No statistical analyses for this end point

    Secondary: Number of participants with spontaneous or traumatic bleeding episodes

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    End point title
    		 Number of participants with spontaneous or traumatic bleeding episodes
    End point description
    Number of participants with spontaneous or traumatic bleeding episodes without regard to treatment
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Factor XIII
    Number of subjects analysed
    41
    Units: participants
    9
    No statistical analyses for this end point

    Secondary: Severity of bleeding episodes

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    End point title
    		 Severity of bleeding episodes
    End point description
    Each bleeding episode was rated by the investigator to indicate the primary location of the bleed, with a rating of minor, moderate, or severe, as follows: • Minor: uncomplicated hemarthroses; superficial muscular or soft tissue hemorrhage, • Moderate: intramuscular or soft tissue hemorrhage with dissection; hemorrhage in mucous membranes, gross hematuria, dental work, or • Severe: hemorrhage in the pharynx, retropharynx, retroperitoneum, or central nervous system (CNS).
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Factor XIII
    Number of subjects analysed
    9 [2]
    Units: participants
        Minor
    7
        Moderate
    2
        Severe
    0
    Notes
    [2] - Participants with a bleeding episode (spontaneous, traumatic, and/or surgical)
    No statistical analyses for this end point

    Secondary: Bleeding episodes by CTCAE grade

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    End point title
    		 Bleeding episodes by CTCAE grade
    End point description
    Bleeding episode severity was categorized from Grade 1 to 5 by the investigator using the National Cancer Institute’s (NCI) Common Terminology Criteria for Adverse Events (Version 3.0) (CTCAE) according to the following: • Grade 1, Mild: Symptoms are easily tolerated and there is no interference with daily activities. • Grade 2, Moderate: Discomfort enough to cause some interference with daily activities. • Grade 3, Severe: Incapacitating with inability to work or do usual activity. • Grade 4, Life-Threatening: Results in a threat to life or in an incapacitating disability. • Grade 5, Death.
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Factor XIII
    Number of subjects analysed
    9 [3]
    Units: participants
        Grade 1 - Mild
    6
        Grade 2 - Moderate
    3
        Grade 3 - Severe
    0
        Grade 4 - Life-threatening
    0
        Grade 5 - Fatal
    0
    Notes
    [3] - Participants with a bleeding episode (spontaneous, traumatic and/or surgical)
    No statistical analyses for this end point

    Secondary: Etiology of bleeding episodes

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    End point title
    		 Etiology of bleeding episodes
    End point description
    The primary etiology of the bleeding episode was rated as spontaneous, traumatic (including exercise-induced bleeding), associated with surgery, or “other”. Participants may have been counted in more than 1 etiology category due to experiencing more than one bleeding episode.
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Factor XIII
    Number of subjects analysed
    9 [4]
    Units: participants
        Spontaneous
    3
        Traumatic
    8
        Associated with Surgery
    1
        Other
    0
    Notes
    [4] - Participants with a bleeding episode (spontaneous, traumatic and/or surgical)
    No statistical analyses for this end point

    Secondary: Number of participants with a primary hemostatic efficacy rating of successful after FXIII treatment of an acute bleeding episode or for prophylaxis before scheduled surgery

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    End point title
    		 Number of participants with a primary hemostatic efficacy rating of successful after FXIII treatment of an acute bleeding episode or for prophylaxis before scheduled surgery
    End point description
    Hemostatic efficacy following Factor XIII Concentrate (Human) treatment of spontaneous, traumatic, or acute bleeding episodes, and during scheduled surgery where an additional dose of Factor XIII Concentrate (Human) was given pre-surgery was assessed clinically by the investigator or treating physician. Successful hemostatic efficacy following Factor XIII Concentrate (Human) treatment of an acute bleeding episode was defined as complete or incomplete restoration of hemostasis in the absence of other IV hemostatic intervention (e.g., cryo, plasma, Factor XIII). Successful hemostatic efficacy during surgery (following Factor XIII Concentrate [Human] administration pre-surgery) was assessed as normal or mildly abnormal hemostasis in terms of quantity and/or quality (e.g., slight oozing, prolonged time to hemostasis with somewhat increased bleeding compared to a non-factor deficient subject) in the absence of other IV hemostatic intervention (e.g., cryo, plasma, Factor XIII).
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Factor XIII
    Number of subjects analysed
    3 [5]
    Units: participants
        Acute bleeding episode (N=1)
    1
        Prophylaxis before surgery (N=2)
    2
    Notes
    [5] - Participants treated with FXIII for acute bleeding (1) or prophylaxis before surgery (2)
    No statistical analyses for this end point

    Secondary: Association of the Incidence of Spontaneous Bleeding Events Requiring Treatment and FXIII Activity Trough Levels

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    End point title
    		 Association of the Incidence of Spontaneous Bleeding Events Requiring Treatment and FXIII Activity Trough Levels
    End point description
    P-value determined from Generalized Estimating Equation (GEE) model parameter estimates with bleeding as the response variable and FXIII activity trough level as the explanatory variable. Note: no subjects had spontaneous bleeding events requiring treatment with a FXIII-containing product, so no subjects were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Factor XIII
    Number of subjects analysed
    0 [6]
    Units: p-value
        number (not applicable)
    Notes
    [6] - Participants with spontaneous bleeding events requiring treatment with a FXIII-containing product.
    No statistical analyses for this end point

    Secondary: Peak FXIII Concentration at Steady State

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    End point title
    		 Peak FXIII Concentration at Steady State
    End point description
    End point type
    Secondary
    End point timeframe
    At 12, 24, 36 and 48 weeks: at 30 and 60 minutes after the end of the infusion.
    End point values
    		 Factor XIII
    Number of subjects analysed
    41 [7]
    Units: IU/mL
    arithmetic mean (standard deviation)
        Week 12 (n = 40)
    0.968 ± 0.2292
        Week 24 (n = 40)
    1.045 ± 0.3825
        Week 36 (n = 41)
    0.962 ± 0.2306
        Week 48 (n = 40)
    0.983 ± 0.2633
    Notes
    [7] - Subjects who received a dose of FXIII Concentrate (human) for whom valid PK parameters were obtained
    No statistical analyses for this end point

    Secondary: Trough FXIII Concentration at Steady State

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    End point title
    		 Trough FXIII Concentration at Steady State
    End point description
    End point type
    Secondary
    End point timeframe
    At 12, 24, 36 and 48 weeks: immediately before infusion.
    End point values
    		 Factor XIII
    Number of subjects analysed
    41 [8]
    Units: IU/mL
    arithmetic mean (standard deviation)
        Week 12 (n = 40)
    0.132 ± 0.0305
        Week 24 (n = 41)
    0.136 ± 0.0362
        Week 36 (n = 41)
    0.13 ± 0.0254
        Week 48 (n = 41)
    0.15 ± 0.1138
    Notes
    [8] - Subjects who received a dose of FXIII Concentrate (human) for whom valid PK parameters were obtained
    No statistical analyses for this end point

    Secondary: Time to Peak Concentration

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    End point title
    		 Time to Peak Concentration
    End point description
    End point type
    Secondary
    End point timeframe
    At 12, 24, 36 and 48 weeks: immediately before infusion, then at 30 and 60 minutes after the end of the infusion
    End point values
    		 Factor XIII
    Number of subjects analysed
    41 [9]
    Units: hours
    arithmetic mean (standard deviation)
        Week 12 (n = 40)
    0.632 ± 0.2296
        Week 24 (n = 40)
    0.615 ± 0.1978
        Week 36 (n = 39)
    0.623 ± 0.235
        Week 48 (n = 40)
    0.636 ± 0.2328
    Notes
    [9] - Subjects who received a dose of FXIII Concentrate (human) for whom valid PK parameters were obtained
    No statistical analyses for this end point

    Secondary: Incremental Recovery

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    End point title
    		 Incremental Recovery
    End point description
    Incremental recovery (IU/mL/IU/kg) is defined as maximum (peak) FXIII activity (IU/mL) obtained following infusion, per dose of (IU/kg) infusion.
    End point type
    Secondary
    End point timeframe
    At 12, 24, 36 and 48 weeks: immediately before infusion, then at 30 and 60 minutes after the end of the infusion.
    End point values
    		 Factor XIII
    Number of subjects analysed
    41 [10]
    Units: IU/mL/IU/kg
    arithmetic mean (standard deviation)
        Week 12 (n = 39)
    0.021 ± 0.0059
        Week 24 (n = 38)
    0.023 ± 0.0104
        Week 36 (n = 39)
    0.021 ± 0.0056
        Week 48 (n = 38)
    0.02 ± 0.0056
    Notes
    [10] - Subjects who received a dose of FXIII Concentrate (human) for whom valid PK parameters were obtained
    No statistical analyses for this end point

    Secondary: Number of participants Achieving Trough Factor XIII Levels of 5% or Higher

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    End point title
    		 Number of participants Achieving Trough Factor XIII Levels of 5% or Higher
    End point description
    The number of participants with Factor XIII level ≥ 5% before infusion at Week 12, Week 24, Week 36 and Week 48.
    End point type
    Secondary
    End point timeframe
    At 12, 24, 36 and 48 weeks: immediately before infusion.
    End point values
    		 Factor XIII
    Number of subjects analysed
    41 [11]
    Units: participants
        Week 12 (n = 40)
    40
        Week 24 (n = 41)
    41
        Week 36 (n = 41)
    41
        Week 48 (n = 41)
    40
    Notes
    [11] - Participants with data at each visit/time point.
    No statistical analyses for this end point

    Secondary: Number of participants with adverse events

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    End point title
    		 Number of participants with adverse events
    End point description
    Number of subjects with any treatment-emergent adverse event (AE), treatment-related AE or serious AE (SAE). Treatment related AEs are defined as AEs whose relationship to study treatment is related, or possibly related, and AEs with missing relationship.
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Factor XIII
    Number of subjects analysed
    41
    Units: participants
        Any treatment-emergent AEs
    33
        Any treatment-emergent and treatment-related AE
    3
        Any treatment-emergent SAE
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 months
    Adverse event reporting additional description
    The Safety Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study. Data presented for other, non-serious AEs are for treatment-emergent AEs.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Factor XIII
    Reporting group description
    		 Initially, subjects received Factor XIII Concentrate (Human) at a dose of 40 U/kg by intravenous (IV) infusion. Subsequent doses were guided by the individual subject’s Factor XIII activity levels, with the objective of dosing every 28 days (4 weeks) to maintain a Factor XIII activity trough level of approximately 5 to 20%. Subjects remained in the study for up to approximately 1 year.

    Serious adverse events
    		 Factor XIII
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 41 (9.76%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Hip injury
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Traumatic chest injury NOS
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chest pain with radiation to left arm
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Factor XIII
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 41 (65.85%)
    Investigations
    Thrombin-antithrombin III complex increased
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    5
    Injury, poisoning and procedural complications
    Abrasions
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    5
    Fall
         subjects affected / exposed
    4 / 41 (9.76%)
         occurrences all number
    4
    Bruising of thigh
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    10
    General disorders and administration site conditions
    Fever
         subjects affected / exposed
    5 / 41 (12.20%)
         occurrences all number
    5
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    6
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 41 (12.20%)
         occurrences all number
    6
    Nasal congestion
         subjects affected / exposed
    4 / 41 (9.76%)
         occurrences all number
    4
    Rhinorrhea
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    4
    Sore throat
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Wrist pain
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    Infections and infestations
    Upper respiratory infection
         subjects affected / exposed
    10 / 41 (24.39%)
         occurrences all number
    11

    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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