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    Clinical Trial Results:
    Efficacy and safety of opicapone in clinical practice in Parkinson’s Disease patients with wearing-off motor fluctuations

    Summary
    EudraCT number
    2016-002391-27
    Trial protocol
    GB   DE  
    Global end of trial date
    10 Jul 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    17 Oct 2019
    First version publication date
    17 Oct 2019
    Other versions
    Summary report(s)
    Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    BIA-OPC-401
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    BIAL - Portela & CA, S.A.
    Sponsor organisation address
    À Av. Siderurgia Nacional, Coronado, Portugal, 4745-457
    Public contact
    André Garrido, BIAL - Portela & Cª, S.A., 00351 229866100, andre.garrido@bial.com
    Scientific contact
    José Francisco Rocha, BIAL - Portela & Cª, S.A., 00351 229866100, jose.rocha@bial.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
    17 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the change in subject’s condition according to the Investigator’s Global Assessment of Change after three months of treatment with 50 mg opicapone once daily in a heterogeneous patient population reflecting daily clinical practice.
    Protection of trial subjects
    This trial will be performed in specialised neurological centres and neurological private practices. The trial will be conducted in compliance with this protocol, by trial personnel, who are qualified by education, training, and experience in their roles, with adherence to Good Clinical Practice (GCP), the applicable regulatory requirements, and ethical principles based on the Declaration of Helsinki.
    Background therapy
    L-dopa/DDCI
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Nov 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 134
    Country: Number of subjects enrolled
    Germany: 372
    Worldwide total number of subjects
    506
    EEA total number of subjects
    506
    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)
    167
    From 65 to 84 years
    333
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects of ≥ 30 years of age with documented history of diagnosed with idiopathic PD and treated with three to seven daily doses of L-dopa/DDCI or L-dopa/DDCI/entacapone were recruited.

    Pre-assignment
    Screening details
    506 subjects were enrolled. 4 subjects were screening failures. Further 7 screened subjects prematurely discontinued from the trial before taking IMP.

    Pre-assignment period milestones
    Number of subjects started
    506
    Number of subjects completed
    495

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Ineligibility: 4
    Reason: Number of subjects
    Other: 2
    Reason: Number of subjects
    Non-compliance: 1
    Reason: Number of subjects
    Consent withdrawn by subject: 4
    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Opicapone
    Arm description
    Opicapone (BIA 9-1067), 50mg hard capsules, once daily in the evening
    Arm type
    Experimental

    Investigational medicinal product name
    Opicapone
    Investigational medicinal product code
    OPC
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    All subjects will start treatment with 50 mg OPC in the evening on the day of Visit 1 and will take 50 mg OPC once daily throughout the entire trial. The last OPC intake will take place in the evening prior to Visit 4. The 50 mg OPC capsule has to be taken once daily at bedtime at least one hour before or after the last L-dopa/DDCI dose.

    Number of subjects in period 1 [1]
    Opicapone
    Started
    495
    Completed
    386
    Not completed
    109
         Other
    4
         Lack of efficacy
    3
         Non-compliance
    2
         Adverse event, non-fatal
    76
         Consent withdrawn by subject
    14
         Adverse event, serious non-fatal
    8
         Development of exclusion criterion
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline period does not include 1 subject who was a screening failure.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Opicapone
    Reporting group description
    Opicapone (BIA 9-1067), 50mg hard capsules, once daily in the evening

    Reporting group values
    Opicapone Total
    Number of subjects
    495 495
    Age Categorical
    Age Categorical Characteristic
    Units: Subjects
        In Utero
    0 0
        Preterm newborn- gestational age < 37 wk
    0 0
        Newborns (0-27days)
    0 0
        Infants and toddlers (28days – 23months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 year)
    0 0
        From 18 - 64 years
    164 164
        From 65 – 84 years
    325 325
        Over 85 years
    6 6
    Age Continuous
    Age Continuous Characteristic
    Units: Years
        arithmetic mean (standard deviation)
    67.7 ± 8.98 -
    Gender Categorical
    Gender Categorical Characteristic
    Units: Subjects
        Female
    179 179
        Male
    315 315
        Missing
    1 1

    End points

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    End points reporting groups
    Reporting group title
    Opicapone
    Reporting group description
    Opicapone (BIA 9-1067), 50mg hard capsules, once daily in the evening

    Subject analysis set title
    Opicapone x Safety Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All subjects who received at least one dose of OPC.

    Subject analysis set title
    Opicapone x Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All subjects treated with at least one dose of OPC and with at least one Investigator’s Global Assessment of Change.

    Subject analysis set title
    Opicapone x Per Protocol Set
    Subject analysis set type
    Per protocol
    Subject analysis set description
    All subjects of the FAS without any major protocol deviation.

    Primary: Investigator's Global Assessment of Change

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    End point title
    Investigator's Global Assessment of Change [1]
    End point description
    Investigator’s Global Assessment of Change at Visit 4.
    End point type
    Primary
    End point timeframe
    Baseline up to Visit 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: No statistical analyses have been performed for this primary end point.
    End point values
    Opicapone x Full Analysis Set
    Number of subjects analysed
    477
    Units: Number of subjects
    number (not applicable)
        Not assessed
    3
        Very much improved
    31
        Much improved
    174
        Minimally improved
    135
        No change
    88
        Minimally worse
    28
        Much worse
    15
        Very much worse
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs with onset or worsening after first intake of IMP until trial termination (regularly or premature).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Opicapone x Safety Set
    Reporting group description
    All subjects who received at least one dose of OPC.

    Serious adverse events
    Opicapone x Safety Set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    34 / 495 (6.87%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Vascular disorders
    Aortic stenosis
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypertension
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Inflammation of wound
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ligament sprain
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Dementia
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Drop attacks
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Freezing phenomenon
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Parkinson's disease
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hallucination, visual
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Faecal vomiting
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Volvulus
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Spondylolisthesis
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Endocarditis
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    3 / 495 (0.61%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Opicapone x Safety Set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    365 / 495 (73.74%)
    Vascular disorders
    Blood pressure fluctuation
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Flushing
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Hot flush
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Hypertension
         subjects affected / exposed
    7 / 495 (1.41%)
         occurrences all number
    7
    Hypertensive crisis
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Hypotension
         subjects affected / exposed
    11 / 495 (2.22%)
         occurrences all number
    11
    Orthostatic hypotension
         subjects affected / exposed
    3 / 495 (0.61%)
         occurrences all number
    3
    Pallor
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Phlebitis
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Seasonal allergy
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Social circumstances
    Gambling
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Chest pain
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Chills
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Crying
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Discomfort
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Drug effect decreased
         subjects affected / exposed
    11 / 495 (2.22%)
         occurrences all number
    11
    Fatigue
         subjects affected / exposed
    15 / 495 (3.03%)
         occurrences all number
    15
    Gait disturbance
         subjects affected / exposed
    6 / 495 (1.21%)
         occurrences all number
    6
    Influenza like illness
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Malaise
         subjects affected / exposed
    3 / 495 (0.61%)
         occurrences all number
    3
    Medical device site mass
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Medical device site rash
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    2
    Mucosal dryness
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Oedema
         subjects affected / exposed
    3 / 495 (0.61%)
         occurrences all number
    3
    Oedema peripheral
         subjects affected / exposed
    4 / 495 (0.81%)
         occurrences all number
    5
    Pain
         subjects affected / exposed
    11 / 495 (2.22%)
         occurrences all number
    11
    Pyrexia
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Abnormal dreams
         subjects affected / exposed
    9 / 495 (1.82%)
         occurrences all number
    10
    Affect lability
         subjects affected / exposed
    3 / 495 (0.61%)
         occurrences all number
    3
    Aggression
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Agitation
         subjects affected / exposed
    4 / 495 (0.81%)
         occurrences all number
    4
    Anorgasmia
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Anxiety
         subjects affected / exposed
    12 / 495 (2.42%)
         occurrences all number
    12
    Apathy
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Confusional state
         subjects affected / exposed
    14 / 495 (2.83%)
         occurrences all number
    16
    Depressed mood
         subjects affected / exposed
    8 / 495 (1.62%)
         occurrences all number
    8
    Depression
         subjects affected / exposed
    18 / 495 (3.64%)
         occurrences all number
    18
    Disinhibition
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Disorientation
         subjects affected / exposed
    5 / 495 (1.01%)
         occurrences all number
    5
    Hallucination
         subjects affected / exposed
    20 / 495 (4.04%)
         occurrences all number
    24
    Hallucination, auditory
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Hallucination, olfactory
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    2
    Hallucination, visual
         subjects affected / exposed
    10 / 495 (2.02%)
         occurrences all number
    13
    Hypersexuality
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Impulse-control disorder
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Initial insomnia
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    22 / 495 (4.44%)
         occurrences all number
    25
    Libido increased
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Middle insomnia
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Nervousness
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Nightmare
         subjects affected / exposed
    5 / 495 (1.01%)
         occurrences all number
    6
    Obsessive-compulsive disorder
         subjects affected / exposed
    3 / 495 (0.61%)
         occurrences all number
    4
    Paranoia
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Persecutory delusion
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Persistent depressive disorder
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Rapid eye movement sleep behaviour disorder
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Rapid eye movements sleep abnormal
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Restlessness
         subjects affected / exposed
    14 / 495 (2.83%)
         occurrences all number
    15
    Sleep attacks
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Sleep disorder
         subjects affected / exposed
    11 / 495 (2.22%)
         occurrences all number
    12
    Somnambulism
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Tearfulness
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Chest injury
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Concussion
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Contusion
         subjects affected / exposed
    7 / 495 (1.41%)
         occurrences all number
    8
    Epicondylitis
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Eye injury
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Face injury
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Fall
         subjects affected / exposed
    30 / 495 (6.06%)
         occurrences all number
    45
    Fibula fracture
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Hand fracture
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Head injury
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Humerus fracture
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Laceration
         subjects affected / exposed
    3 / 495 (0.61%)
         occurrences all number
    3
    Muscle strain
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Pubis fracture
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Rib fracture
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Scratch
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    4
    Thermal burn
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Upper limb fracture
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Wrist fracture
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Investigations
    Blood cholesterol increased
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Blood folate decreased
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Blood magnesium decreased
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Blood pressure decreased
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Blood pressure increased
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Body temperature increased
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Bone density decreased
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Cardiac murmur
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Heart rate increased
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Lymph node palpable
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Nuclear magnetic resonance imaging abnormal
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Serum ferritin decreased
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Weight decreased
         subjects affected / exposed
    6 / 495 (1.21%)
         occurrences all number
    6
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Tachycardia
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Congenital, familial and genetic disorders
    Congenital cystic kidney disease
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    2
    Cough
         subjects affected / exposed
    7 / 495 (1.41%)
         occurrences all number
    7
    Dry throat
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Dysphonia
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Dyspnoea
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Dyspnoea exertional
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Epistaxis
         subjects affected / exposed
    3 / 495 (0.61%)
         occurrences all number
    3
    Nasal congestion
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Oropharyngeal pain
         subjects affected / exposed
    3 / 495 (0.61%)
         occurrences all number
    3
    Pharyngeal erythema
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Wheezing
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Iron deficiency anaemia
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Akinesia
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Altered state of consciousness
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Balance disorder
         subjects affected / exposed
    6 / 495 (1.21%)
         occurrences all number
    6
    Bradykinesia
         subjects affected / exposed
    11 / 495 (2.22%)
         occurrences all number
    12
    Burning feet syndrome
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Decreased vibratory sense
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Dementia
         subjects affected / exposed
    3 / 495 (0.61%)
         occurrences all number
    3
    Dementia with Lewy bodies
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Disturbance in attention
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Dizziness
         subjects affected / exposed
    29 / 495 (5.86%)
         occurrences all number
    30
    Dizziness postural
         subjects affected / exposed
    4 / 495 (0.81%)
         occurrences all number
    4
    Dysarthria
         subjects affected / exposed
    3 / 495 (0.61%)
         occurrences all number
    3
    Dysgeusia
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Dyskinesia
         subjects affected / exposed
    71 / 495 (14.34%)
         occurrences all number
    79
    Dystonia
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Facial paralysis
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Fine motor skill dysfunction
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Freezing phenomenon
         subjects affected / exposed
    6 / 495 (1.21%)
         occurrences all number
    6
    Headache
         subjects affected / exposed
    13 / 495 (2.63%)
         occurrences all number
    13
    Hyperkinesia
         subjects affected / exposed
    6 / 495 (1.21%)
         occurrences all number
    6
    Hyperreflexia
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Hypoaesthesia
         subjects affected / exposed
    8 / 495 (1.62%)
         occurrences all number
    8
    Hypokinesia
         subjects affected / exposed
    8 / 495 (1.62%)
         occurrences all number
    8
    Memory impairment
         subjects affected / exposed
    4 / 495 (0.81%)
         occurrences all number
    4
    Mental impairment
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Microsleep
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Myasthenia gravis
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Neuropathy peripheral
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    On and off phenomenon
         subjects affected / exposed
    12 / 495 (2.42%)
         occurrences all number
    13
    Orthostatic intolerance
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Orthostatic tremor
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Paraesthesia
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Parkinson's disease
         subjects affected / exposed
    8 / 495 (1.62%)
         occurrences all number
    8
    Parkinsonian gait
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Parkinsonism
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Polyneuropathy
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Poor quality sleep
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Presyncope
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Psychomotor hyperactivity
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Restless legs syndrome
         subjects affected / exposed
    8 / 495 (1.62%)
         occurrences all number
    8
    Sciatica
         subjects affected / exposed
    5 / 495 (1.01%)
         occurrences all number
    6
    Sensory disturbance
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Somnolence
         subjects affected / exposed
    10 / 495 (2.02%)
         occurrences all number
    10
    Speech disorder
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Syncope
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Tremor
         subjects affected / exposed
    18 / 495 (3.64%)
         occurrences all number
    18
    Visual field defect
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Eye disorders
    Astigmatism
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Blepharitis
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Cataract
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Diplopia
         subjects affected / exposed
    4 / 495 (0.81%)
         occurrences all number
    4
    Dry eye
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Eye movement disorder
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Eyelid oedema
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Lacrimation increased
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Saccadic eye movement
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Vision blurred
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Visual impairment
         subjects affected / exposed
    4 / 495 (0.81%)
         occurrences all number
    5
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Excessive cerumen production
         subjects affected / exposed
    3 / 495 (0.61%)
         occurrences all number
    3
    Hypoacusis
         subjects affected / exposed
    3 / 495 (0.61%)
         occurrences all number
    3
    Tinnitus
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Vertigo
         subjects affected / exposed
    6 / 495 (1.21%)
         occurrences all number
    7
    Vertigo positional
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Abdominal distension
         subjects affected / exposed
    3 / 495 (0.61%)
         occurrences all number
    3
    Abdominal pain
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Abdominal pain upper
         subjects affected / exposed
    10 / 495 (2.02%)
         occurrences all number
    12
    Aptyalism
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    43 / 495 (8.69%)
         occurrences all number
    47
    Diarrhoea
         subjects affected / exposed
    13 / 495 (2.63%)
         occurrences all number
    14
    Dry mouth
         subjects affected / exposed
    40 / 495 (8.08%)
         occurrences all number
    45
    Dyspepsia
         subjects affected / exposed
    4 / 495 (0.81%)
         occurrences all number
    4
    Dysphagia
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Epigastric discomfort
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Eructation
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Flatulence
         subjects affected / exposed
    4 / 495 (0.81%)
         occurrences all number
    4
    Gastric mucosa erythema
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Gastritis erosive
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    4 / 495 (0.81%)
         occurrences all number
    4
    Haemorrhoids
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Lip swelling
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    35 / 495 (7.07%)
         occurrences all number
    38
    Oesophagitis
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Oral pain
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Saliva discolouration
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Salivary hypersecretion
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    8 / 495 (1.62%)
         occurrences all number
    8
    Renal and urinary disorders
    Chromaturia
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Incontinence
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Micturition urgency
         subjects affected / exposed
    4 / 495 (0.81%)
         occurrences all number
    4
    Nocturia
         subjects affected / exposed
    5 / 495 (1.01%)
         occurrences all number
    5
    Pollakiuria
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Polyuria
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Renal cyst
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Urge incontinence
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Urinary incontinence
         subjects affected / exposed
    3 / 495 (0.61%)
         occurrences all number
    3
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Hepatic cyst
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Dry skin
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Erythema
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Hand dermatitis
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Hyperhidrosis
         subjects affected / exposed
    9 / 495 (1.82%)
         occurrences all number
    9
    Night sweats
         subjects affected / exposed
    3 / 495 (0.61%)
         occurrences all number
    3
    Pigmentation disorder
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Psoriasis
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    4 / 495 (0.81%)
         occurrences all number
    4
    Rash pruritic
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Rosacea
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Skin irritation
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Skin striae
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Product issues
    Device dislocation
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    7 / 495 (1.41%)
         occurrences all number
    7
    Back pain
         subjects affected / exposed
    16 / 495 (3.23%)
         occurrences all number
    16
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Joint swelling
         subjects affected / exposed
    4 / 495 (0.81%)
         occurrences all number
    4
    Limb discomfort
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Mobility decreased
         subjects affected / exposed
    11 / 495 (2.22%)
         occurrences all number
    12
    Muscle rigidity
         subjects affected / exposed
    11 / 495 (2.22%)
         occurrences all number
    13
    Muscle spasms
         subjects affected / exposed
    13 / 495 (2.63%)
         occurrences all number
    14
    Muscle tightness
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Muscle twitching
         subjects affected / exposed
    5 / 495 (1.01%)
         occurrences all number
    6
    Muscular weakness
         subjects affected / exposed
    4 / 495 (0.81%)
         occurrences all number
    4
    Musculoskeletal pain
         subjects affected / exposed
    3 / 495 (0.61%)
         occurrences all number
    3
    Musculoskeletal stiffness
         subjects affected / exposed
    5 / 495 (1.01%)
         occurrences all number
    5
    Myalgia
         subjects affected / exposed
    4 / 495 (0.81%)
         occurrences all number
    4
    Neck pain
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Osteoarthritis
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Osteochondrosis
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Osteoporosis
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    12 / 495 (2.42%)
         occurrences all number
    14
    Rheumatoid arthritis
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Spinal column stenosis
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Spinal pain
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Tendonitis
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Abnormal loss of weight
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Decreased appetite
         subjects affected / exposed
    5 / 495 (1.01%)
         occurrences all number
    5
    Diabetes mellitus
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Food craving
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Gout
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Hyperkalaemia
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Hypovolaemia
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Magnesium deficiency
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Vitamin B12 deficiency
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Vitamin D deficiency
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Infections and infestations
    Angular cheilitis
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Candida infection
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Cellulitis
         subjects affected / exposed
    3 / 495 (0.61%)
         occurrences all number
    3
    Chronic sinusitis
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Cystitis
         subjects affected / exposed
    5 / 495 (1.01%)
         occurrences all number
    5
    Eye infection
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Gastrointestinal infection
         subjects affected / exposed
    4 / 495 (0.81%)
         occurrences all number
    4
    Influenza
         subjects affected / exposed
    3 / 495 (0.61%)
         occurrences all number
    4
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 495 (0.61%)
         occurrences all number
    3
    Nasopharyngitis
         subjects affected / exposed
    19 / 495 (3.84%)
         occurrences all number
    20
    Onychomycosis
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Pulpitis dental
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2
    Tooth infection
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 495 (0.20%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    7 / 495 (1.41%)
         occurrences all number
    9
    Viral infection
         subjects affected / exposed
    2 / 495 (0.40%)
         occurrences all number
    2

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Sep 2016
    Global Protocol Amendment No. 1, DE
    20 Sep 2016
    Global Protocol Amendment No. 1, UK
    03 Nov 2016
    Global Protocol Amendment No. 2, UK
    20 Dec 2016
    Global Protocol Amendment No. 2, DE
    20 Dec 2016
    Global Protocol Amendment No. 3, UK
    20 Sep 2017
    Global Protocol Amendment No. 4, UK
    17 Oct 2017
    Global Protocol Amendment No. 3, DE

    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
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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