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    Clinical Trial Results:
    Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies (BROADWAY): A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With Underlying HeFH and/or Atherosclerotic Cardiovascular Disease (ASCVD) Who are Not Adequately Controlled by Their Lipid Modifying Therapies

    Summary
    EudraCT number
    		 2021-005065-40
    Trial protocol
    		 NL   DK   CZ  
    Global end of trial date
    26 Sep 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2025
    First version publication date
    23 Oct 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    TA-8995-302
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05142722
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    NewAmsterdam Pharma B.V.
    Sponsor organisation address
    Gooimeer 2-35, DC Naarden, Netherlands, 1411
    Public contact
    Study Director, NewAmsterdam Pharma B.V., +31 35 2062971 , study.director@newamsterdampharma.com
    Scientific contact
    Study Director, NewAmsterdam Pharma B.V., +31 35 2062971 , study.director@newamsterdampharma.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
    27 Feb 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Sep 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the effect of obicetrapib on LDL-C levels at Day 84.
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki and with all applicable laws and regulations of the locale and country where the study was conducted, and in compliance with Good Clinical Practice Guidelines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Dec 2021
    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
    United States: 904
    Country: Number of subjects enrolled
    Denmark: 91
    Country: Number of subjects enrolled
    Poland: 403
    Country: Number of subjects enrolled
    Czechia: 161
    Country: Number of subjects enrolled
    Netherlands: 226
    Country: Number of subjects enrolled
    China: 317
    Country: Number of subjects enrolled
    Georgia: 298
    Country: Number of subjects enrolled
    Japan: 130
    Worldwide total number of subjects
    2530
    EEA total number of subjects
    881
    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)
    1066
    From 65 to 84 years
    1437
    85 years and over
    27

    Subject disposition

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    Recruitment
    Recruitment details
    		 4214 patients were screened: out of 4214, 2530 participants were randomized (2:1) (obicetrapib: placebo): 1686 participants to the obicetrapib 10 mg group and 844 participants to the placebo group

    Pre-assignment
    Screening details
    		 4214 patients were screened

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 one placebo tablet once daily; Placebo: placebo tablet made to resemble active
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matching placebo tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily matching placebo tablet

    Arm title
    		 Obicetrapib 10 mg
    Arm description
    		 one 10 mg obicetrapib tablet once daily; Obicetrapib: 10 mg obicetrapib tablet
    Arm type
    		 Experimental

    Investigational medicinal product name
    Obicetrapib 10 mg tablet
    Investigational medicinal product code
    TA-8995
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and administration details: once daily 10 mg obicetrapib tablet

    Number of subjects in period 1
    		Placebo Obicetrapib 10 mg
    Started
    844
    1686
    Completed
    795
    1600
    Not completed
    49
    86
         Consent withdrawn by subject
    20
    27
         Physician decision
    -
    1
         Adverse event, non-fatal
    2
    1
         Death
    11
    17
         Participant Moved Away
    -
    2
         Lost to follow-up
    16
    38

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 one placebo tablet once daily; Placebo: placebo tablet made to resemble active

    Reporting group title
    Obicetrapib 10 mg
    Reporting group description
    		 one 10 mg obicetrapib tablet once daily; Obicetrapib: 10 mg obicetrapib tablet

    Reporting group values
    		 Placebo Obicetrapib 10 mg Total
    Number of subjects
    		 844 1686 2530
    Age categorical
    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)
    		 360 706 1066
        From 65-84 years
    		 469 968 1437
        85 years and over
    		 15 12 27
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.3 ( 9.61 ) 65.4 ( 9.90 ) -
    Gender categorical
    Units: Subjects
        Female
    		 280 573 853
        Male
    		 564 1113 1677
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 46 80 126
        Not Hispanic or Latino
    		 798 1605 2403
        Unknown or Not Reported
    		 0 1 1
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 1 5 6
        Asian
    		 150 312 462
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 39 112 151
        White
    		 647 1241 1888
        More than one race
    		 2 7 9
        Unknown or Not Reported
    		 5 9 14
    Baseline Low-Density Lipoprotein Cholesterol (LDL-C)
    Baseline LDL-C is defined as the last measurement prior to the first dose of study drug. LDL-C was measured by Preparative Ultracentrifugation (PUC).
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 98.4 ( 37.94 ) 98.1 ( 37.05 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 one placebo tablet once daily; Placebo: placebo tablet made to resemble active

    Reporting group title
    Obicetrapib 10 mg
    Reporting group description
    		 one 10 mg obicetrapib tablet once daily; Obicetrapib: 10 mg obicetrapib tablet

    Primary: 1. Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC]

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    End point title
    		 1. Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC]
    End point description
    LS mean percent change from baseline to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group [PUC]. LDL-C level was measured by preparative ultracentrifugation (PUC).
    End point type
    Primary
    End point timeframe
    84 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    842
    1679
    Units: Percent Change from Baseline
        least squares mean (standard error)
    2.70 ( 1.571 )
    -29.94 ( 1.104 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Obicetrapib 10 mg v Placebo
    Number of subjects included in analysis
    2521
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -32.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -35.79
         upper limit
    		 -29.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.602

    Secondary: 2. Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins]

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    End point title
    		 2. Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins]
    End point description
    LS mean percent change from baseline to Day 180 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group [Martin/Hopkins]. LDL-C value was calculated using the Martin/Hopkins equation unless TG >= 400 mg/dL or LDL-C <= 50 mg/dL; where, LDL-C value was measured directly by preparative ultracentrifugation (PUC).
    End point type
    Secondary
    End point timeframe
    180 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    843
    1685
    Units: percent change from baseline
        least squares mean (standard error)
    4.68 ( 1.625 )
    -29.09 ( 1.176 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib 10 mg
    Number of subjects included in analysis
    2528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -33.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37.07
         upper limit
    		 -30.49
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.678

    Secondary: 3. Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC]

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    End point title
    		 3. Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC]
    End point description
    LS mean percent change from baseline to Day 365 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group [PUC]. LDL-C level was measured by preparative ultracentrifugation (PUC).
    End point type
    Secondary
    End point timeframe
    365 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    842
    1679
    Units: percent change from baseline
        least squares mean (standard error)
    -1.27 ( 1.798 )
    -25.25 ( 1.480 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib 10 mg
    Number of subjects included in analysis
    2521
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -23.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.87
         upper limit
    		 -20.09
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.979
    Notes
    [1] - The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value <0.05

    Secondary: 4. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84

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    End point title
    		 4. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84
    End point description
    LS mean percent change from baseline to Day 84 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.
    End point type
    Secondary
    End point timeframe
    84 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    843
    1685
    Units: percent change from baseline
        least squares mean (standard error)
    1.08 ( 0.911 )
    -17.84 ( 0.669 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib 10 mg
    Number of subjects included in analysis
    2528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [2]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -18.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.76
         upper limit
    		 -17.09
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.936
    Notes
    [2] - The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value<0.05

    Secondary: 5. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180

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    End point title
    		 5. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180
    End point description
    LS mean percent change from baseline to Day 180 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.
    End point type
    Secondary
    End point timeframe
    180 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    843
    1685
    Units: percent change from baseline
        least squares mean (standard error)
    2.23 ( 1.033 )
    -16.07 ( 0.742 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib 10 mg
    Number of subjects included in analysis
    2528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [3]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -18.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.38
         upper limit
    		 -16.23
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.057
    Notes
    [3] - The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value<0.05

    Secondary: 6. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 365

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    End point title
    		 6. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 365
    End point description
    LS mean percent change from baseline to Day 365 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.
    End point type
    Secondary
    End point timeframe
    365 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    843
    1685
    Units: percent change from baseline
        least squares mean (standard error)
    -1.77 ( 1.165 )
    -15.57 ( 0.914 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib 10 mg
    Number of subjects included in analysis
    2528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [4]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -13.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.2
         upper limit
    		 -11.41
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.219
    Notes
    [4] - The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value<0.05

    Secondary: 7. Percent Change in Non-HDL-C From Baseline to Day 84

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    End point title
    		 7. Percent Change in Non-HDL-C From Baseline to Day 84
    End point description
    LS mean percent change from baseline to Day 84 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) in obicetrapib group compared to the placebo group.
    End point type
    Secondary
    End point timeframe
    84 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    843
    1685
    Units: percent change from baseline
        least squares mean (standard error)
    2.81 ( 1.212 )
    -26.64 ( 0.892 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Obicetrapib 10 mg v Placebo
    Number of subjects included in analysis
    2528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [5]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -29.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31.89
         upper limit
    		 -26.99
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.251
    Notes
    [5] - The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value<0.05

    Secondary: 8. Percent Change in Non-HDL-C From Baseline to Day 180

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    End point title
    		 8. Percent Change in Non-HDL-C From Baseline to Day 180
    End point description
    LS mean percent change from baseline to Day 180 in Non-high-density Lipoprotein Cholesterol (non-HDL-C) in obicetrapib group compared to the placebo group.
    End point type
    Secondary
    End point timeframe
    180 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    843
    1685
    Units: percent change from baseline
        least squares mean (standard error)
    3.68 ( 1.302 )
    -24.63 ( 0.972 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib 10 mg
    Number of subjects included in analysis
    2528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [6]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -28.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.94
         upper limit
    		 -25.69
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.339
    Notes
    [6] - The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value<0.05

    Secondary: 9. Percent Change in Non-HDL-C From Baseline to Day 365

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    End point title
    		 9. Percent Change in Non-HDL-C From Baseline to Day 365
    End point description
    LS mean percent change from baseline to Day 365 in Non-high-density Lipoprotein Cholesterol (non-HDL-C) in obicetrapib group compared to the placebo group.
    End point type
    Secondary
    End point timeframe
    365 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    843
    1685
    Units: percent change from baseline
        least squares mean (standard error)
    0.63 ( 1.480 )
    -22.38 ( 1.186 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib 10 mg
    Number of subjects included in analysis
    2528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [7]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -23.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.09
         upper limit
    		 -19.95
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.564
    Notes
    [7] - The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value<0.05

    Secondary: 10. Percent Change in HDL-C From Baseline to Day 84

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    End point title
    		 10. Percent Change in HDL-C From Baseline to Day 84
    End point description
    LS mean percent change from baseline to Day 84 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group.
    End point type
    Secondary
    End point timeframe
    84 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    843
    1685
    Units: percent change from baseline
        least squares mean (standard error)
    0.61 ( 1.391 )
    136.87 ( 1.857 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib 10 mg
    Number of subjects included in analysis
    2528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    136.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 132.46
         upper limit
    		 140.07
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.939

    Secondary: 11. Percent Change in HDL-C From Baseline to Day 180

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    End point title
    		 11. Percent Change in HDL-C From Baseline to Day 180
    End point description
    LS mean percent change from baseline to Day 180 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group.
    End point type
    Secondary
    End point timeframe
    180 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    843
    1685
    Units: percent change from baseline
        least squares mean (standard error)
    1.18 ( 1.897 )
    135.61 ( 2.192 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib 10 mg
    Number of subjects included in analysis
    2528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [8]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    134.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 129.84
         upper limit
    		 139.03
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.343
    Notes
    [8] - The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value<0.05

    Secondary: 12. Percent Change in HDL-C From Baseline to Day 365

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    End point title
    		 12. Percent Change in HDL-C From Baseline to Day 365
    End point description
    LS mean percent change from baseline to Day 365 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group.
    End point type
    Secondary
    End point timeframe
    365 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    843
    1685
    Units: percent change from baseline
        least squares mean (standard error)
    3.36 ( 1.651 )
    125.40 ( 2.193 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Obicetrapib 10 mg v Placebo
    Number of subjects included in analysis
    2528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [9]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    122.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 117.53
         upper limit
    		 126.55
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.299
    Notes
    [9] - The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value<0.05

    Secondary: 13. Percent Change in Lp(a) From Baseline to Day 84

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    End point title
    		 13. Percent Change in Lp(a) From Baseline to Day 84
    End point description
    LS mean percent change from baseline to Day 84 in Lipoprotein (a) [Lp(a)] in obicetrapib group compared to the placebo group.
    End point type
    Secondary
    End point timeframe
    84 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    843
    1685
    Units: percent change from baseline
        least squares mean (standard error)
    13.65 ( 8.240 )
    -0.48 ( 19.855 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib 10 mg
    Number of subjects included in analysis
    2528
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4841 [10]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -14.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -53.68
         upper limit
    		 25.44
    Variability estimate
    Standard error of the mean
    Dispersion value
    20.183
    Notes
    [10] - The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value<0.05; therefore hierarchical testing was stopped for subsequent secondary endpoints

    Secondary: 14. Percent Change in Apolipoprotein A1 (ApoA1) From Baseline to Day 84

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    End point title
    		 14. Percent Change in Apolipoprotein A1 (ApoA1) From Baseline to Day 84
    End point description
    LS mean percent change from baseline to Day 84 in Apolipoprotein A1 (ApoA1) in obicetrapib group compared to the placebo group.
    End point type
    Secondary
    End point timeframe
    84 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    843
    1685
    Units: percent change from baseline
        least squares mean (standard error)
    0.26 ( 0.597 )
    43.44 ( 0.686 )
    No statistical analyses for this end point

    Secondary: 15. Percent Change in Total Cholesterol From Baseline to Day 84

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    End point title
    		 15. Percent Change in Total Cholesterol From Baseline to Day 84
    End point description
    LS mean percent change from baseline to Day 84 in Total Cholesterol (TC) in obicetrapib group compared to the placebo group.
    End point type
    Secondary
    End point timeframe
    84 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    843
    1685
    Units: percent change from baseline
        least squares mean (standard error)
    -0.02 ( 0.757 )
    17.66 ( 0.702 )
    No statistical analyses for this end point

    Secondary: 16. Percent Change in Total Cholesterol From Baseline to Day 180

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    End point title
    		 16. Percent Change in Total Cholesterol From Baseline to Day 180
    End point description
    LS mean percent change from baseline to Day 180 in Total Cholesterol in obicetrapib group compared to the placebo group.
    End point type
    Secondary
    End point timeframe
    180 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    843
    1685
    Units: percent change from baseline
        least squares mean (standard error)
    0.85 ( 0.893 )
    18.68 ( 0.769 )
    No statistical analyses for this end point

    Secondary: 17. Percent Change in Total Cholesterol From Baseline to Day 365

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    End point title
    		 17. Percent Change in Total Cholesterol From Baseline to Day 365
    End point description
    LS mean percent change from baseline to Day 365 in Total Cholesterol in obicetrapib group compared to the placebo group.
    End point type
    Secondary
    End point timeframe
    365 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    843
    1685
    Units: percent change from baseline
        least squares mean (standard error)
    -0.58 ( 1.030 )
    17.96 ( 0.886 )
    No statistical analyses for this end point

    Secondary: 18. Percent Change in Triglycerides From Baseline to Day 84

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    End point title
    		 18. Percent Change in Triglycerides From Baseline to Day 84
    End point description
    LS mean percent change from baseline to Day 84 in Triglycerides in obicetrapib group compared to the placebo group.
    End point type
    Secondary
    End point timeframe
    84 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    843
    1685
    Units: percent change from baseline
        least squares mean (standard error)
    7.66 ( 1.814 )
    -0.17 ( 1.445 )
    No statistical analyses for this end point

    Secondary: 19. Percent Change in Triglycerides From Baseline to Day 180

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    End point title
    		 19. Percent Change in Triglycerides From Baseline to Day 180
    End point description
    LS mean percent change from baseline to Day 180 in Triglycerides in obicetrapib group compared to the placebo group.
    End point type
    Secondary
    End point timeframe
    180 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    843
    1685
    Units: percent change from baseline
        least squares mean (standard error)
    8.22 ( 2.061 )
    0.25 ( 1.584 )
    No statistical analyses for this end point

    Secondary: 20. Percent Change in Triglycerides From Baseline to Day 365

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    End point title
    		 20. Percent Change in Triglycerides From Baseline to Day 365
    End point description
    LS mean percent change from baseline to Day 365 in Triglycerides in obicetrapib group compared to the placebo group.
    End point type
    Secondary
    End point timeframe
    365 days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    843
    1685
    Units: percent change from baseline
        least squares mean (standard error)
    6.33 ( 2.135 )
    0.60 ( 1.781 )
    No statistical analyses for this end point

    Post-hoc: 21. Percent Change in Lp(a) From Baseline to Day 84 (Hodges-Lehman)

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    End point title
    		 21. Percent Change in Lp(a) From Baseline to Day 84 (Hodges-Lehman)
    End point description
    Median percent change from baseline to Day 84 in Lipoprotein (a) [Lp(a)] in obicetrapib group compared to the placebo group.
    End point type
    Post-hoc
    End point timeframe
    84 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    843
    1685
    Units: percent change from baseline
        median (inter-quartile range (Q1-Q3))
    -0.9 (-15.7 to 13.0)
    -32.3 (-62.8 to -4.7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug up to Week 54
    Adverse event reporting additional description
    Safety Population included all participants who received at least 1 dose of any study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 one placebo tablet once daily; Placebo: placebo tablet made to resemble active

    Reporting group title
    Obicetrapib 10 mg
    Reporting group description
    		 one 10 mg Obicetrapib tablet once daily; Obicetrapib: 10 mg Obicetrapib tablet

    Serious adverse events
    		 Placebo Obicetrapib 10 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    117 / 843 (13.88%)
    211 / 1685 (12.52%)
         number of deaths (all causes)
    12
    19
         number of deaths resulting from adverse events
    12
    19
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    2 / 843 (0.24%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    2 / 843 (0.24%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma pancreas
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer metastatic
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malignant melanoma
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma stage IV
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases to central nervous system
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastases to liver
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oesophageal squamous cell carcinoma
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Papillary cystadenoma lymphomatosum
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer recurrent
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 843 (0.24%)
    3 / 1685 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    2 / 843 (0.24%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    1 / 843 (0.12%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 843 (0.00%)
    2 / 1685 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    1 / 843 (0.12%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iliac artery stenosis
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral venous disease
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Varicose vein
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (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
    2 / 843 (0.24%)
    3 / 1685 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    3 / 843 (0.36%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 843 (0.12%)
    2 / 1685 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Sudden cardiac death
         subjects affected / exposed
    0 / 843 (0.00%)
    3 / 1685 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Asthenia
         subjects affected / exposed
    2 / 843 (0.24%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exercise tolerance decreased
         subjects affected / exposed
    0 / 843 (0.00%)
    2 / 1685 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac death
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chest discomfort
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fat necrosis
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent stenosis
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    2 / 843 (0.24%)
    2 / 1685 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    2 / 843 (0.24%)
    4 / 1685 (0.24%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 843 (0.24%)
    3 / 1685 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    2 / 843 (0.24%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 843 (0.00%)
    2 / 1685 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    2 / 843 (0.24%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 843 (0.12%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 843 (0.12%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial haemorrhage
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary alveolar haemorrhage
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord thickening
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcoholism
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiovascular somatic symptom disorder
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device malfunction
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International normalised ratio increased
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    White blood cell count increased
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 843 (0.00%)
    2 / 1685 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    0 / 843 (0.00%)
    2 / 1685 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 843 (0.00%)
    2 / 1685 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropod bite
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniofacial injury
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delayed recovery from anaesthesia
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb traumatic amputation
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax traumatic
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft thrombosis
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    10 / 843 (1.19%)
    17 / 1685 (1.01%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 18
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Angina unstable
         subjects affected / exposed
    8 / 843 (0.95%)
    17 / 1685 (1.01%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    4 / 843 (0.47%)
    7 / 1685 (0.42%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    7 / 843 (0.83%)
    3 / 1685 (0.18%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Cardiac failure
         subjects affected / exposed
    4 / 843 (0.47%)
    5 / 1685 (0.30%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 843 (0.00%)
    7 / 1685 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute left ventricular failure
         subjects affected / exposed
    4 / 843 (0.47%)
    2 / 1685 (0.12%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 843 (0.00%)
    6 / 1685 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 843 (0.12%)
    4 / 1685 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 843 (0.12%)
    4 / 1685 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 843 (0.12%)
    3 / 1685 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    2 / 843 (0.24%)
    2 / 1685 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    2 / 843 (0.24%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    3 / 843 (0.36%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    2 / 843 (0.24%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    0 / 843 (0.00%)
    3 / 1685 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic coronary syndrome
         subjects affected / exposed
    2 / 843 (0.24%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 843 (0.00%)
    3 / 1685 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    0 / 843 (0.00%)
    2 / 1685 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    2 / 843 (0.24%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    0 / 843 (0.00%)
    2 / 1685 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiovascular disorder
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microvascular coronary artery disease
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    2 / 843 (0.24%)
    7 / 1685 (0.42%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    3 / 843 (0.36%)
    6 / 1685 (0.36%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 843 (0.12%)
    7 / 1685 (0.42%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Ischaemic stroke
         subjects affected / exposed
    1 / 843 (0.12%)
    4 / 1685 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Syncope
         subjects affected / exposed
    2 / 843 (0.24%)
    3 / 1685 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    1 / 843 (0.12%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic neuropathy
         subjects affected / exposed
    0 / 843 (0.00%)
    2 / 1685 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic cerebral infarction
         subjects affected / exposed
    1 / 843 (0.12%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain stem haemorrhage
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Dizziness
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial nerve disorder
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lacunar infarction
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine with aura
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normal pressure hydrocephalus
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tension headache
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic encephalopathy
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 843 (0.12%)
    3 / 1685 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normocytic anaemia
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract nuclear
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic retinopathy
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric ulcer haemorrhage
         subjects affected / exposed
    0 / 843 (0.00%)
    2 / 1685 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 843 (0.12%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal polyp
         subjects affected / exposed
    1 / 843 (0.12%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal adhesions
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric artery thrombosis
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer haemorrhage
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal fissure
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 843 (0.12%)
    2 / 1685 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute hepatic failure
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary obstruction
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver injury
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    0 / 843 (0.00%)
    2 / 1685 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperhidrosis
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 843 (0.24%)
    5 / 1685 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 843 (0.12%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Primary hyperaldosteronism
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (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
    Osteoarthritis
         subjects affected / exposed
    2 / 843 (0.24%)
    4 / 1685 (0.24%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest wall haematoma
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gouty arthritis
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint range of motion decreased
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb discomfort
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myopathy
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Temporomandibular joint syndrome
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    6 / 843 (0.71%)
    9 / 1685 (0.53%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    3 / 843 (0.36%)
    4 / 1685 (0.24%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 843 (0.00%)
    4 / 1685 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 843 (0.12%)
    2 / 1685 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 843 (0.00%)
    3 / 1685 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 843 (0.00%)
    2 / 1685 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 843 (0.12%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis acute
         subjects affected / exposed
    1 / 843 (0.12%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 843 (0.12%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 843 (0.00%)
    2 / 1685 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 843 (0.12%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess oral
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella infection
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural cellulitis
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinitis
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superinfection bacterial
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 843 (0.12%)
    3 / 1685 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 843 (0.12%)
    2 / 1685 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 843 (0.12%)
    1 / 1685 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic complication
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 843 (0.12%)
    0 / 1685 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    0 / 843 (0.00%)
    1 / 1685 (0.06%)
         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: 2%
    Non-serious adverse events
    		 Placebo Obicetrapib 10 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    241 / 843 (28.59%)
    459 / 1685 (27.24%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    33 / 843 (3.91%)
    82 / 1685 (4.87%)
         occurrences all number
    33
    89
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    15 / 843 (1.78%)
    40 / 1685 (2.37%)
         occurrences all number
    15
    44
    Headache
         subjects affected / exposed
    17 / 843 (2.02%)
    43 / 1685 (2.55%)
         occurrences all number
    18
    45
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    24 / 843 (2.85%)
    38 / 1685 (2.26%)
         occurrences all number
    28
    40
    Infections and infestations
    COVID-19
         subjects affected / exposed
    48 / 843 (5.69%)
    81 / 1685 (4.81%)
         occurrences all number
    49
    81
    Nasopharyngitis
         subjects affected / exposed
    22 / 843 (2.61%)
    43 / 1685 (2.55%)
         occurrences all number
    26
    55
    Upper respiratory tract infection
         subjects affected / exposed
    33 / 843 (3.91%)
    49 / 1685 (2.91%)
         occurrences all number
    35
    54
    Urinary tract infection
         subjects affected / exposed
    21 / 843 (2.49%)
    39 / 1685 (2.31%)
         occurrences all number
    25
    41
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    28 / 843 (3.32%)
    44 / 1685 (2.61%)
         occurrences all number
    33
    46

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Dec 2021
    This amendment was developed to reflect an increase in the planned number of participants and sites, to modify the participant population, to provide additional guidance for serious adverse event (SAE) reporting, and to improve clarity and consistency within the study protocol.
    11 Jan 2022
    This amendment was developed to modify the participant population, to alter language regarding breaking the blind, and to improve clarity and consistency within the study protocol.
    15 Jul 2022
    This amendment was developed primarily to incorporate feedback from the United States Food and Drug Administration and to improve clarity and consistency within the study protocol
    19 Aug 2022
    This amendment was developed primarily to incorporate feedback from the United States Food and Drug Administration, to modify eligibility criteria in an effort to improve study enrollment, and to improve clarity and consistency within the study protocol.
    30 Dec 2022
    This amendment was developed to improve clarity and consistency within the study protocol.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/38705341
    http://www.ncbi.nlm.nih.gov/pubmed/40337982
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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