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    Clinical Trial Results:
    A Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia type 2

    Summary
    EudraCT number
    		 2017-003234-82
    Trial protocol
    		 GB   FR  
    Global end of trial date
    09 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Aug 2024
    First version publication date
    04 Aug 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    NTMT-03-A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03316300
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Neurotech Pharmaceuticals Inc
    Sponsor organisation address
    900 Highland Corporate Drive, Suite 101, Cumberland, RI, United States, 02864
    Public contact
    Kevin Hibbert, Neurotech Pharmaceuticals, k.hibbert@neurotechusa.com
    Scientific contact
    Kevin Hibbert, Neurotech Pharmaceuticals, k.hibbert@neurotechusa.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
    30 Nov 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Aug 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The overall objective of this study is to evaluate the efficacy and safety of NT-501 for the treatment of MacTel. Primary objective: To determine the rate of change in the area of ellipsoid zone (EZ) loss (photoreceptor inner segment/outer segment [IS/OS]; macular photoreceptor loss) over 24 months, as measured by spectral domain-optical coherence tomography (SD-OCT) in the study eye of subjects with macular telangiectasia type 2 (MacTel). The secondary objective: To evaluate the safety of NT-501 in subjects with MacTel.
    Protection of trial subjects
    Ethics committee approval
    Background therapy
    		 None
    Evidence for comparator
    		 A sham surgical procedure was performed to mimic the implant procedure; there was no comparator product.
    Actual start date of recruitment
    17 Nov 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 12
    Country: Number of subjects enrolled
    United States: 78
    Country: Number of subjects enrolled
    United Kingdom: 15
    Country: Number of subjects enrolled
    France: 15
    Worldwide total number of subjects
    120
    EEA total number of subjects
    15
    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)
    78
    From 65 to 84 years
    42
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Screening period for up to 30 days

    Pre-assignment
    Screening details
    		 NTMT-03-A: 120 subjects enrolled (5 participants withdrew after randomization) but prior to the implantation/sham surgery procedure; 61 subjects in NT-501 arm and 59 subjects in sham arm.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Subject, Data analyst, Carer, Assessor
    Blinding implementation details
    The subjects and all personnel at the image reading center remained masked to the treatment assignment throughout the study. In addition, the refractionist, VA examiner, and photographers/imagers were masked to treatment assignment (NT-501 implantation or sham procedure) at all follow-up visits. The ophthalmologist, surgeon, and clinic coordinator were instructed not to discuss the assigned treatment with the subject.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 NT-501
    Arm description
    		 Test product
    Arm type
    		 Experimental

    Investigational medicinal product name
    NT-501 Implant
    Investigational medicinal product code
    NT-501
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Intravitreal use
    Dosage and administration details
    Each implant consisting of hCNTF-secreting NTC-201-6A.02 cells encapsulated within supportive matrices and surrounded by a semipermeable polymer membrane. The NTC-201-6A cells continuously secrete CNTF from the NT-501 implant into the vitreous cavity. Implanted by a qualified Health Care Professional.

    Arm title
    		 Sham Procedure
    Arm description
    		 A sham surgical procedure was performed to mimic the implant procedure; there was no comparator product.
    Arm type
    		 sham surgical procedure

    Investigational medicinal product name
    Sham procedure
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Intravitreal use
    Dosage and administration details
    The sham surgery involved a superficial conjunctival incision performed under local anesthetic and closure with a single suture.

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: The subjects and all personnel at the image reading center remained masked to the treatment assignment throughout the study. In addition, the refractionist, VA examiner, and photographers/imagers were masked to treatment assignment (NT-501 implantation or sham procedure) at all follow-up visits. The ophthalmologist, surgeon, and clinic coordinator were instructed not to discuss the assigned treatment with the subject.
    Number of subjects in period 1
    		NT-501 Sham Procedure
    Started
    61
    59
    Completed
    53
    52
    Not completed
    8
    7
         Consent withdrawn by subject
    3
    2
         Eligible and did not enroll in amendment
    4
    4
         Adverse event, non-fatal
    1
    -
         COVID-19
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 120 120
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 78 78
        From 65-84 years
    		 42 42
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 82 82
        Male
    		 38 38
    Subject analysis sets

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population included all randomized subjects who underwent either NT-501 implantation surgery or sham surgery and had at least 1 safety measurement.

    Subject analysis set title
    Modified Intention-to-Treat population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The mITT population comprised all randomized subjects who underwent either NT-501 implantation surgery or sham surgery

    Subject analysis set title
    Per Protocol Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP population included all subjects in the mITT population who had no important protocol deviations (ie, deviations that may have had a substantial impact on the primary efficacy endpoint).

    Subject analysis sets values
    		 Safety population Modified Intention-to-Treat population Per Protocol Population
    Number of subjects
    115
    115
    111
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    74
    74
    72
        From 65-84 years
    41
    41
    39
        85 years and over
    Age continuous
    Units:
        
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    79
    79
    77
        Male
    36
    36
    34

    End points

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    End points reporting groups
    Reporting group title
    NT-501
    Reporting group description
    		 Test product

    Reporting group title
    Sham Procedure
    Reporting group description
    		 A sham surgical procedure was performed to mimic the implant procedure; there was no comparator product.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population included all randomized subjects who underwent either NT-501 implantation surgery or sham surgery and had at least 1 safety measurement.

    Subject analysis set title
    Modified Intention-to-Treat population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The mITT population comprised all randomized subjects who underwent either NT-501 implantation surgery or sham surgery

    Subject analysis set title
    Per Protocol Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP population included all subjects in the mITT population who had no important protocol deviations (ie, deviations that may have had a substantial impact on the primary efficacy endpoint).

    Primary: Primary Efficacy Endpoint

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    End point title
    		 Primary Efficacy Endpoint
    End point description
    The rate of change in the area of EZ loss (IS/OS; macular photoreceptor loss) from baseline through month 24, as assessed using SD-OCT in the study eye of subjects with MacTel.
    End point type
    Primary
    End point timeframe
    End point timeframe is 2 years Baseline, Month 6, 12, 16, 20 and 24. Month 6 was collected but not included in the primary analyses.
    End point values
    		 NT-501 Sham Procedure
    Number of subjects analysed
    58
    57
    Units: mm^2
        number (not applicable)
    0.075
    0.166
    Statistical analysis title
    		 Statistical Analysis - NT-501 vs Sham Procedure
    Statistical analysis description
    The efficacy and safety of the NT-501 implant that delivers a daily dose of CNTF in comparison to sham surgery with no implant, in participants with confirmed MacTel.
    Comparison groups
    NT-501 v Sham Procedure
    Number of subjects included in analysis
    115
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 longitudinal mixed model
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.091
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.13
         upper limit
    		 -0.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0176

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the Clinical Trial
    Adverse event reporting additional description
    Please note that only non-ocular and ocular events in the study eye have been reported. The Adverse events reported are those that occurred through month 24.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    NT-501
    Reporting group description
    		 Test product

    Reporting group title
    Sham Procedure
    Reporting group description
    		 A sham surgical procedure was performed to mimic the implant procedure; there was no comparator product.

    Serious adverse events
    		 NT-501 Sham Procedure
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 58 (20.69%)
    7 / 57 (12.28%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Suture related complication
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue injury
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Coronary arterial stent insertion
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cystocele
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 NT-501 Sham Procedure
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    54 / 58 (93.10%)
    47 / 57 (82.46%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 57 (1.75%)
         occurrences all number
    1
    1
    Eye naevus
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Colorectal adenoma
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Lung carcinoma cell type unspecified recurrent
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Salivary gland neoplasm
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 58 (1.72%)
    5 / 57 (8.77%)
         occurrences all number
    1
    5
    Deep vein thrombosis
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Essential hypertension
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Raynaud's phenomenon
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    Mole excision
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Skin neoplasm excision
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Chest pain
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Influenza like illness
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    Fatigue
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Swelling face
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Seasonal allergy
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Erectile dysfunction
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Ovarian cyst
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 58 (3.45%)
    1 / 57 (1.75%)
         occurrences all number
    2
    1
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Obstructive sleep apnoea syndrome
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    Anxiety
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Investigations
    Intraocular pressure increased
         subjects affected / exposed
    2 / 58 (3.45%)
    1 / 57 (1.75%)
         occurrences all number
    2
    1
    Biopsy prostate abnormal
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Blood glucose increased
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Endoscopy gastrointestinal
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Heart rate irregular
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Staphylococcus test positive
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Suture related complication
         subjects affected / exposed
    2 / 58 (3.45%)
    1 / 57 (1.75%)
         occurrences all number
    2
    1
    Cataract traumatic
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Corneal abrasion
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Hyphaema
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Fall
         subjects affected / exposed
    1 / 58 (1.72%)
    2 / 57 (3.51%)
         occurrences all number
    1
    2
    Tooth fracture
         subjects affected / exposed
    2 / 58 (3.45%)
    1 / 57 (1.75%)
         occurrences all number
    2
    1
    Soft tissue injury
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 57 (1.75%)
         occurrences all number
    1
    1
    Back injury
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Comminuted fracture
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Contusion
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Dental restoration failure
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Foot fracture
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Joint dislocation
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Ligament injury
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Muscle injury
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Procedural nausea
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Skin laceration
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Tendon injury
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Upper limb fracture
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Wound dehiscence
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Wrist fracture
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Congenital, familial and genetic disorders
    Type V hyperlipidaemia
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Corneal dystrophy
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 57 (1.75%)
         occurrences all number
    1
    1
    Angina pectoris
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 57 (1.75%)
         occurrences all number
    1
    1
    Arrhythmia
         subjects affected / exposed
    0 / 58 (0.00%)
    2 / 57 (3.51%)
         occurrences all number
    0
    2
    Coronary artery occlusion
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Tachycardia
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Coronary artery disease
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 57 (1.75%)
         occurrences all number
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 58 (6.90%)
    3 / 57 (5.26%)
         occurrences all number
    4
    3
    Neuropathy peripheral
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    Balance disorder
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Carotid artery occlusion
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Cubital tunnel syndrome
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Memory impairment
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Metabolic encephalopathy
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Migraine
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Parkinson's disease
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Radiculopathy
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Sciatica
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Sinus headache
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Syncope
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    0 / 58 (0.00%)
    2 / 57 (3.51%)
         occurrences all number
    0
    2
    Excessive cerumen production
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Vertigo
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    18 / 58 (31.03%)
    12 / 57 (21.05%)
         occurrences all number
    18
    12
    Dry eye
         subjects affected / exposed
    8 / 58 (13.79%)
    6 / 57 (10.53%)
         occurrences all number
    8
    6
    Delayed dark adaptation
         subjects affected / exposed
    12 / 58 (20.69%)
    1 / 57 (1.75%)
         occurrences all number
    12
    1
    Eye pain
         subjects affected / exposed
    8 / 58 (13.79%)
    5 / 57 (8.77%)
         occurrences all number
    8
    5
    Foreign body sensation in eyes
         subjects affected / exposed
    6 / 58 (10.34%)
    7 / 57 (12.28%)
         occurrences all number
    6
    7
    Eye pruritus
         subjects affected / exposed
    9 / 58 (15.52%)
    3 / 57 (5.26%)
         occurrences all number
    9
    3
    Miosis
         subjects affected / exposed
    10 / 58 (17.24%)
    0 / 57 (0.00%)
         occurrences all number
    10
    0
    Vision blurred
         subjects affected / exposed
    7 / 58 (12.07%)
    3 / 57 (5.26%)
         occurrences all number
    7
    3
    Ocular discomfort
         subjects affected / exposed
    8 / 58 (13.79%)
    1 / 57 (1.75%)
         occurrences all number
    8
    1
    Conjunctival hyperaemia
         subjects affected / exposed
    4 / 58 (6.90%)
    3 / 57 (5.26%)
         occurrences all number
    4
    3
    Vitreous floaters
         subjects affected / exposed
    7 / 58 (12.07%)
    0 / 57 (0.00%)
         occurrences all number
    7
    0
    Conjunctival oedema
         subjects affected / exposed
    4 / 58 (6.90%)
    2 / 57 (3.51%)
         occurrences all number
    4
    2
    Choroidal neovascularisation
         subjects affected / exposed
    0 / 58 (0.00%)
    2 / 57 (3.51%)
         occurrences all number
    0
    2
    Cataract
         subjects affected / exposed
    3 / 58 (5.17%)
    1 / 57 (1.75%)
         occurrences all number
    3
    1
    Cataract subcapsular
         subjects affected / exposed
    3 / 58 (5.17%)
    0 / 57 (0.00%)
         occurrences all number
    3
    0
    Eye irritation
         subjects affected / exposed
    4 / 58 (6.90%)
    0 / 57 (0.00%)
         occurrences all number
    4
    0
    Iridocyclitis
         subjects affected / exposed
    3 / 58 (5.17%)
    1 / 57 (1.75%)
         occurrences all number
    3
    1
    Photopsia
         subjects affected / exposed
    4 / 58 (6.90%)
    0 / 57 (0.00%)
         occurrences all number
    4
    0
    Visual impairment
         subjects affected / exposed
    0 / 58 (0.00%)
    3 / 57 (5.26%)
         occurrences all number
    0
    3
    Vitreous haemorrhage
         subjects affected / exposed
    4 / 58 (6.90%)
    0 / 57 (0.00%)
         occurrences all number
    4
    0
    Blepharospasm
         subjects affected / exposed
    0 / 58 (0.00%)
    2 / 57 (3.51%)
         occurrences all number
    0
    2
    Anterior chamber cell
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    Eye discharge
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    Punctate keratitis
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    Uveitis
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    Vitreous detachment
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    Abnormal sensation in eye
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    Anisocoria
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Corneal pigmentation
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Cystoid macular oedema
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Delayed light adaptation
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Diplopia
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Eccentric fixation
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Lenticular opacities
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Macular oedema
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Meibomian gland dysfunction
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Night blindness
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Photophobia
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Presbyopia
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Retinal artery embolism
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Retinal haemorrhage
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Retinal thickening
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Ulcerative keratitis
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Visual acuity reduced
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Visual field defect
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Vitreoretinal traction syndrome
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Cataract nuclear
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 57 (1.75%)
         occurrences all number
    1
    1
    Epiretinal membrane
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Keratitis
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Diverticulum
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Dyspepsia
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Food poisoning
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Large intestine polyp
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Pancreatic cyst
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Hepatic steatosis
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 58 (0.00%)
    3 / 57 (5.26%)
         occurrences all number
    0
    3
    Blister
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Dermatitis allergic
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Neurodermatitis
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Micturition urgency
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    7 / 58 (12.07%)
    1 / 57 (1.75%)
         occurrences all number
    7
    1
    Arthritis
         subjects affected / exposed
    3 / 58 (5.17%)
    2 / 57 (3.51%)
         occurrences all number
    3
    2
    Osteoarthritis
         subjects affected / exposed
    2 / 58 (3.45%)
    2 / 57 (3.51%)
         occurrences all number
    2
    2
    Tendonitis
         subjects affected / exposed
    3 / 58 (5.17%)
    0 / 57 (0.00%)
         occurrences all number
    3
    0
    Pain in extremity
         subjects affected / exposed
    2 / 58 (3.45%)
    0 / 57 (0.00%)
         occurrences all number
    2
    0
    Back pain
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Bone lesion
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Intervertebral disc degeneration
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Osteonecrosis
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Osteopenia
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Conjunctivitis viral
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Hordeolum
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    COVID-19
         subjects affected / exposed
    3 / 58 (5.17%)
    4 / 57 (7.02%)
         occurrences all number
    3
    4
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 58 (5.17%)
    2 / 57 (3.51%)
         occurrences all number
    3
    2
    Influenza
         subjects affected / exposed
    0 / 58 (0.00%)
    3 / 57 (5.26%)
         occurrences all number
    0
    3
    Nasopharyngitis
         subjects affected / exposed
    2 / 58 (3.45%)
    1 / 57 (1.75%)
         occurrences all number
    2
    1
    Sinusitis
         subjects affected / exposed
    2 / 58 (3.45%)
    1 / 57 (1.75%)
         occurrences all number
    2
    1
    Tooth infection
         subjects affected / exposed
    1 / 58 (1.72%)
    2 / 57 (3.51%)
         occurrences all number
    1
    2
    Herpes zoster
         subjects affected / exposed
    0 / 58 (0.00%)
    2 / 57 (3.51%)
         occurrences all number
    0
    2
    Pneumonia
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 57 (1.75%)
         occurrences all number
    1
    1
    Sepsis
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 58 (1.72%)
    1 / 57 (1.75%)
         occurrences all number
    1
    1
    Abscess jaw
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Abscess limb
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Cellulitis
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Impetigo
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Infected bite
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Staphylococcal infection
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Suspected COVID-19
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Tooth abscess
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Wound abscess
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Vaginal infection
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 58 (1.72%)
    0 / 57 (0.00%)
         occurrences all number
    1
    0
    Glucose tolerance impaired
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Hypernatraemia
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1
    Vitamin D deficiency
         subjects affected / exposed
    0 / 58 (0.00%)
    1 / 57 (1.75%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jun 2019
    Protocol Version 4.0 Global
    12 Apr 2021
    Protocol Version 6.1
    31 Aug 2021
    Protocol Verison 7.0

    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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