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    Clinical Trial Results:
    CONVINCE - (COlchicine for preventioN of Vascular Inflammation in Non- CardioEmbolic stroke) – a randomised clinical trial of low-dose colchicine for secondary prevention after stroke

    Summary
    EudraCT number
    		 2015-004505-16
    Trial protocol
    		 IE   ES   GB   DE   CZ   DK   PT   BE   LT   NL  
    Global end of trial date
    31 Jan 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jun 2025
    First version publication date
    07 Jun 2025
    Other versions
    Summary report(s)
    		 The Lancet CONVINCE June 2024

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CONVINCE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02898610
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University College Dublin
    Sponsor organisation address
    UCD Clinical Research Centre, Dublin, Ireland, D07 A8NN
    Public contact
    Prof Peter Kelly, The Irish Stroke Clinical Trials Network, 353 17164576, pjkelly@mater.ie
    Scientific contact
    Prof Peter Kelly, The Irish Stroke Clinical Trials Network, 353 17164575, pjkelly@mater.ie
    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
    31 Jan 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jan 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the efficacy of low dose colchicine (0.5mg/day) plus usual care (antiplatelet, lipid-lowering, antihypertensive treatment, and appropriate lifestyle advice) compared with usual care alone to prevent non-fatal recurrent ischaemic stroke, myocardial infarction, cardiac arrest, and vascular death after ischaemic stroke or transient ischaemic attack (TIA) not caused by cardiac embolism or other defined causes unrelated to atherosclerosis.
    Protection of trial subjects
    PROBE Study design aligned with clinical care. Patient visits every 6 months.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Dec 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Ethical reason, Regulatory reason, Scientific research
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 18
    Country: Number of subjects enrolled
    Poland: 68
    Country: Number of subjects enrolled
    Portugal: 122
    Country: Number of subjects enrolled
    Spain: 277
    Country: Number of subjects enrolled
    United Kingdom: 1219
    Country: Number of subjects enrolled
    Belgium: 365
    Country: Number of subjects enrolled
    Czechia: 21
    Country: Number of subjects enrolled
    Denmark: 74
    Country: Number of subjects enrolled
    Estonia: 12
    Country: Number of subjects enrolled
    Germany: 428
    Country: Number of subjects enrolled
    Ireland: 478
    Country: Number of subjects enrolled
    Lithuania: 14
    Country: Number of subjects enrolled
    Canada: 36
    Country: Number of subjects enrolled
    Switzerland: 22
    Worldwide total number of subjects
    3154
    EEA total number of subjects
    1877
    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)
    1367
    From 65 to 84 years
    1707
    85 years and over
    80

    Subject disposition

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    Recruitment
    Recruitment details
    		 A randomised, parallel-group, open-label, blinded endpoint assessed trial comparing long-term colchicine (0·5 mg orally per day) plus guideline-based usual care with usual care only. Hospital-based patients with non-severe, non-cardioembolic ischaemic stroke or high-risk transient ischaemic attack were eligible.

    Pre-assignment
    Screening details
    		 Hospital-based patients with non-severe, non-cardioembolic ischaemic stroke or high-risk transient ischaemic attack were eligible. Full inclusion / exclusion outlined in the trial protocol.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    Only outcome assessors were blinded to which arm the patient was randomised to.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention Arm
    Arm description
    		 Low-dose colchicine, plus usual care (defined in the protocol)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Colchicine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Low-dose colchicine, 0.5mg/day, oral administration

    Arm title
    		 Control Arm
    Arm description
    		 Usual care only, defined as anti-platelet, lipid-lowering, and anti- hypertensive treatment and lifestyle advice (smoking cessation, diet and physical activity), as deemed appropriate by the treating clinician.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Outcome assessor was blinded
    Number of subjects in period 1 [2]
    		Intervention Arm Control Arm
    Started
    1569
    1575
    Completed
    1565
    1572
    Not completed
    4
    3
         Protocol deviation
    4
    3
    Notes
    [2] - 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: 10 patients withdrew consent hence the difference in numbers Number of patients enrolled 3154. Ten patients withdrew consent for analysis of their data, leaving 3144 patients in the intention-to-treat analysis: 1569 (colchicine and usual care) and 1575 (usual care alone).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention Arm
    Reporting group description
    		 Low-dose colchicine, plus usual care (defined in the protocol)

    Reporting group title
    Control Arm
    Reporting group description
    		 Usual care only, defined as anti-platelet, lipid-lowering, and anti- hypertensive treatment and lifestyle advice (smoking cessation, diet and physical activity), as deemed appropriate by the treating clinician.

    Reporting group values
    		 Intervention Arm Control Arm Total
    Number of subjects
    		 1569 1575 3144
    Age categorical
    Age 40 years or greater
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
        Age 40 and greater
    		 1569 1575 3144
    Gender categorical
    Units: Subjects
        Female
    		 488 465 953
        Male
    		 1081 1110 2191

    End points

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    End points reporting groups
    Reporting group title
    Intervention Arm
    Reporting group description
    		 Low-dose colchicine, plus usual care (defined in the protocol)

    Reporting group title
    Control Arm
    Reporting group description
    		 Usual care only, defined as anti-platelet, lipid-lowering, and anti- hypertensive treatment and lifestyle advice (smoking cessation, diet and physical activity), as deemed appropriate by the treating clinician.

    Primary: Outcomes reported

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    End point title
    		 Outcomes reported
    End point description
    Primary efficacy analysis was by intention to treat, comparing time to primary outcome event in colchicine-treated and usual-care groups via a log-rank test. Events confirmed through centralised adjudication to meet protocol-defined primary outcome criteria, were included in the analyses of the number of occurrences of the composite primary outcome for the respective treatment group. The components of the primary composite efficacy outcome measure are defined below: Non-fatal ischaemic stroke (defined in Protocol) Non-fatal myocardial infarction Non-fatal cardiac arrest Hospitalization for Unstable Angina: TIMI definition Vascular death
    End point type
    Primary
    End point timeframe
    The primary efficacy outcome measure will be time to the first occurrence of non-fatal recurrent ischaemic stroke, non-fatal myocardial infarction, non-fatal cardiac arrest, hospitalization for unstable angina or vascular death.
    End point values
    		 Intervention Arm Control Arm
    Number of subjects analysed
    1569
    1575
    Units: number of outcomes
    153
    185
    Statistical analysis title
    		 Primary Analysis
    Statistical analysis description
    The statistical approach was a comparison of time to primary outcome event (first recurrent event in the outcome composite) in colchicine-treated and usual-care groups. The effect size and precision was reported as hazard ratio with 95% confidence intervals using Cox proportional hazards modelling. The hazard ratio was adjusted for the three mandatory minimisation variables (age, duration since last event, type of qualifying event) specified in the randomisation algorithm.
    Comparison groups
    Intervention Arm v Control Arm
    Number of subjects included in analysis
    3144
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 ≤ 0.048 [1]
    Method
    		 COX PH Model
    Parameter type
    		 Hazard ratio (HR)
    Confidence interval
         level
    		 95%
    Notes
    [1] - For the primary analysis, a P-value of 0.048 or less will be considered as statistically significant (two-sided alpha), accounting for the 'alpha-spend' of 0.001 in each of 2 interim analysis.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event collection began at randomisation and finished at the end-of-trial assessment (28 days after last dose of study medication).
    Adverse event reporting additional description
    Subjects were interviewed during each subject visit to determine if an adverse event had occurred. Specific monitoring for the following adverse events performed in colchicine-treated and usual care groups:
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Intervention Arm
    Reporting group description
    		 Low-dose colchicine, plus usual care (defined in the protocol)

    Reporting group title
    Control Arm
    Reporting group description
    		 Usual care only, defined as anti-platelet, lipid-lowering, and anti- hypertensive treatment and lifestyle advice (smoking cessation, diet and physical activity), as deemed appropriate by the treating clinician.

    Serious adverse events
    		 Intervention Arm Control Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    594 / 1569 (37.86%)
    596 / 1575 (37.84%)
         number of deaths (all causes)
    69
    70
         number of deaths resulting from adverse events
    53
    53
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
         subjects affected / exposed
    73 / 1569 (4.65%)
    73 / 1575 (4.63%)
         occurrences causally related to treatment / all
    0 / 87
    0 / 81
         deaths causally related to treatment / all
    0 / 21
    0 / 26
    Vascular disorders
    Vascular disorders
         subjects affected / exposed
    43 / 1569 (2.74%)
    33 / 1575 (2.10%)
         occurrences causally related to treatment / all
    0 / 48
    0 / 35
         deaths causally related to treatment / all
    0 / 6
    0 / 4
    Surgical and medical procedures
    Surgical and medical procedures
         subjects affected / exposed
    91 / 1569 (5.80%)
    101 / 1575 (6.41%)
         occurrences causally related to treatment / all
    0 / 110
    0 / 114
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General disorders and administration site conditions
         subjects affected / exposed
    25 / 1569 (1.59%)
    19 / 1575 (1.21%)
         occurrences causally related to treatment / all
    0 / 26
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Immune System Disorders
         subjects affected / exposed
    3 / 1569 (0.19%)
    0 / 1575 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Social circumstances
         subjects affected / exposed
    1 / 1569 (0.06%)
    0 / 1575 (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
    Reproductive system and breast disorders
         subjects affected / exposed
    4 / 1569 (0.25%)
    4 / 1575 (0.25%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
         subjects affected / exposed
    31 / 1569 (1.98%)
    38 / 1575 (2.41%)
         occurrences causally related to treatment / all
    0 / 45
    0 / 46
         deaths causally related to treatment / all
    0 / 6
    0 / 3
    Psychiatric disorders
    Psychiatric disorders
         subjects affected / exposed
    14 / 1569 (0.89%)
    16 / 1575 (1.02%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 19
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Product issues
    Product issues
         subjects affected / exposed
    1 / 1569 (0.06%)
    0 / 1575 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatobiliary disorders
         subjects affected / exposed
    10 / 1569 (0.64%)
    12 / 1575 (0.76%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Investigations
    Investigations
         subjects affected / exposed
    26 / 1569 (1.66%)
    24 / 1575 (1.52%)
         occurrences causally related to treatment / all
    0 / 28
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Injury, poisoning and procedural complications
         subjects affected / exposed
    62 / 1569 (3.95%)
    62 / 1575 (3.94%)
         occurrences causally related to treatment / all
    0 / 71
    0 / 69
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Congenital, familial and genetic disorders
         subjects affected / exposed
    3 / 1569 (0.19%)
    5 / 1575 (0.32%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac disorders
         subjects affected / exposed
    44 / 1569 (2.80%)
    54 / 1575 (3.43%)
         occurrences causally related to treatment / all
    0 / 59
    0 / 69
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Nervous system disorders
         subjects affected / exposed
    112 / 1569 (7.14%)
    116 / 1575 (7.37%)
         occurrences causally related to treatment / all
    0 / 135
    0 / 149
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
         subjects affected / exposed
    9 / 1569 (0.57%)
    10 / 1575 (0.63%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Ear and labyrinth disorders
         subjects affected / exposed
    7 / 1569 (0.45%)
    10 / 1575 (0.63%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Eye Disorders
         subjects affected / exposed
    4 / 1569 (0.25%)
    7 / 1575 (0.44%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal disorders
         subjects affected / exposed
    46 / 1569 (2.93%)
    48 / 1575 (3.05%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 48
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
         subjects affected / exposed
    6 / 1569 (0.38%)
    4 / 1575 (0.25%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal and urinary disorders
         subjects affected / exposed
    23 / 1569 (1.47%)
    16 / 1575 (1.02%)
         occurrences causally related to treatment / all
    0 / 28
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Endocrine disorders
    Endocrine disorders
         subjects affected / exposed
    1 / 1569 (0.06%)
    1 / 1575 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
         subjects affected / exposed
    20 / 1569 (1.27%)
    29 / 1575 (1.84%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 33
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infections and infestations
         subjects affected / exposed
    256 / 1569 (16.32%)
    252 / 1575 (16.00%)
         occurrences causally related to treatment / all
    0 / 316
    0 / 313
         deaths causally related to treatment / all
    0 / 11
    0 / 9
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
         subjects affected / exposed
    18 / 1569 (1.15%)
    20 / 1575 (1.27%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Intervention Arm Control Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1013 / 1569 (64.56%)
    925 / 1575 (58.73%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
         subjects affected / exposed
    44 / 1569 (2.80%)
    40 / 1575 (2.54%)
         occurrences all number
    49
    42
    Vascular disorders
    Vascular disorders
         subjects affected / exposed
    111 / 1569 (7.07%)
    100 / 1575 (6.35%)
         occurrences all number
    112
    115
    Surgical and medical procedures
    Surgical and medical procedures
         subjects affected / exposed
    88 / 1569 (5.61%)
    93 / 1575 (5.90%)
         occurrences all number
    110
    115
    General disorders and administration site conditions
    General disorders and administration site conditions
         subjects affected / exposed
    99 / 1569 (6.31%)
    105 / 1575 (6.67%)
         occurrences all number
    115
    122
    Immune system disorders
    Immune system disorders
         subjects affected / exposed
    9 / 1569 (0.57%)
    2 / 1575 (0.13%)
         occurrences all number
    9
    2
    Social circumstances
    Social circumstance
         subjects affected / exposed
    2 / 1569 (0.13%)
    1 / 1575 (0.06%)
         occurrences all number
    2
    1
    Reproductive system and breast disorders
    Reproductive system and breast disorders
         subjects affected / exposed
    18 / 1569 (1.15%)
    31 / 1575 (1.97%)
         occurrences all number
    18
    34
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
         subjects affected / exposed
    101 / 1569 (6.44%)
    109 / 1575 (6.92%)
         occurrences all number
    112
    135
    Psychiatric disorders
    Psychiatric disorders
         subjects affected / exposed
    64 / 1569 (4.08%)
    62 / 1575 (3.94%)
         occurrences all number
    69
    71
    Product issues
    Product issues
         subjects affected / exposed
    0 / 1569 (0.00%)
    2 / 1575 (0.13%)
         occurrences all number
    0
    2
    Hepatobiliary disorders
    Hepatobiliary disorders
         subjects affected / exposed
    17 / 1569 (1.08%)
    12 / 1575 (0.76%)
         occurrences all number
    18
    13
    Investigations
    Investigations
         subjects affected / exposed
    206 / 1569 (13.13%)
    177 / 1575 (11.24%)
         occurrences all number
    288
    264
    Injury, poisoning and procedural complications
    Injury, poisoning and procedural complications
         subjects affected / exposed
    136 / 1569 (8.67%)
    125 / 1575 (7.94%)
         occurrences all number
    182
    163
    Congenital, familial and genetic disorders
    Congenital, familial and genetic disorders
         subjects affected / exposed
    8 / 1569 (0.51%)
    7 / 1575 (0.44%)
         occurrences all number
    8
    7
    Cardiac disorders
    Cardiac disorders
         subjects affected / exposed
    101 / 1569 (6.44%)
    117 / 1575 (7.43%)
         occurrences all number
    119
    139
    Nervous system disorders
    Nervous System Disorders
         subjects affected / exposed
    253 / 1569 (16.12%)
    264 / 1575 (16.76%)
         occurrences all number
    338
    346
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
         subjects affected / exposed
    31 / 1569 (1.98%)
    40 / 1575 (2.54%)
         occurrences all number
    34
    55
    Ear and labyrinth disorders
    Ear and labyrinth disorders
         subjects affected / exposed
    29 / 1569 (1.85%)
    30 / 1575 (1.90%)
         occurrences all number
    32
    32
    Eye disorders
    Eye disorders
         subjects affected / exposed
    59 / 1569 (3.76%)
    49 / 1575 (3.11%)
         occurrences all number
    66
    54
    Gastrointestinal disorders
    Gastrointestinal disorders
         subjects affected / exposed
    296 / 1569 (18.87%)
    131 / 1575 (8.32%)
         occurrences all number
    409
    172
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
         subjects affected / exposed
    99 / 1569 (6.31%)
    55 / 1575 (3.49%)
         occurrences all number
    115
    64
    Renal and urinary disorders
    Renal and urinary disorders
         subjects affected / exposed
    80 / 1569 (5.10%)
    75 / 1575 (4.76%)
         occurrences all number
    88
    90
    Endocrine disorders
    Endocrine disorders
         subjects affected / exposed
    4 / 1569 (0.25%)
    14 / 1575 (0.89%)
         occurrences all number
    5
    16
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
         subjects affected / exposed
    200 / 1569 (12.75%)
    198 / 1575 (12.57%)
         occurrences all number
    261
    267
    Infections and infestations
    Infections and infestations
         subjects affected / exposed
    226 / 1569 (14.40%)
    240 / 1575 (15.24%)
         occurrences all number
    316
    319
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
         subjects affected / exposed
    94 / 1569 (5.99%)
    110 / 1575 (6.98%)
         occurrences all number
    109
    127

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Mar 2020
    Temporary Halt to recruitment and contingency arrangements due to COVID 19 pandemic
    15 May 2020
    Recruitment recommenced
    01 Feb 2021
    Increase sample size Change in study timelines Modification of the trial procedures to reduce risk of COVID to trial participants from follow-up visits:

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    20 Mar 2020
    Temporary pause in recruitment due to onset of COVID 19 pandemic
    15 May 2020

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/38857611
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