<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01730040</url>
  </required_header>
  <id_info>
    <org_study_id>R727-CL-1110</org_study_id>
    <nct_id>NCT01730040</nct_id>
  </id_info>
  <brief_title>Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)</brief_title>
  <official_title>A Randomized, Double-Blind Study of the Efficacy and Safety of Alirocumab Added on to Atorvastatin Versus Ezetimibe Added on to Atorvastatin Versus Atorvastatin Dose Increase Versus Switch to Rosuvastatin in Patients Who Are Not Controlled on Atorvastatin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Regeneron Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, double-blind, active-comparator, parallel-group study in patients at&#xD;
      high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial&#xD;
      hypercholesterolemia (heFH).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis</measure>
    <time_frame>From Baseline to Week 24</time_frame>
    <description>Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis</measure>
    <time_frame>From Baseline to Week 24</time_frame>
    <description>Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis</measure>
    <time_frame>From Baseline to Week 24</time_frame>
    <description>Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment (ITT analysis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis</measure>
    <time_frame>From Baseline to Week 24</time_frame>
    <description>Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis</measure>
    <time_frame>From Baseline to Week 24</time_frame>
    <description>Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis</measure>
    <time_frame>From Baseline to Week 24</time_frame>
    <description>Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis</measure>
    <time_frame>From Baseline to Week 24</time_frame>
    <description>Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis</measure>
    <time_frame>From Baseline to Week 24</time_frame>
    <description>Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis</measure>
    <time_frame>From Baseline to Week 24</time_frame>
    <description>Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Apo B at Week 12 - ITT Analysis</measure>
    <time_frame>From Baseline to Week 24</time_frame>
    <description>Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis</measure>
    <time_frame>From Baseline to Week 24</time_frame>
    <description>Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Total-C at Week 12 - ITT Analysis</measure>
    <time_frame>From Baseline to Week 24</time_frame>
    <description>Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Very High CV Risk Participants Reaching Calculated LDL-C &lt;70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C &lt;100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Very High CV Risk Participants Reaching Calculated LDL-C &lt;70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C &lt;100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Reaching Calculated LDL-C &lt;70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Reaching Calculated LDL-C &lt;70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis</measure>
    <time_frame>From Baseline to Week 24</time_frame>
    <description>Adjusted means and standard errors at Week 24 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis</measure>
    <time_frame>From Baseline to Week 24</time_frame>
    <description>Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis</measure>
    <time_frame>From Baseline to Week 24</time_frame>
    <description>Adjusted means and standard errors at Week 24 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis</measure>
    <time_frame>From Baseline to Week 24</time_frame>
    <description>Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis</measure>
    <time_frame>From Baseline to Week 24</time_frame>
    <description>Adjusted means and standard errors at Week 12 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis</measure>
    <time_frame>From Baseline to Week 24</time_frame>
    <description>Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis</measure>
    <time_frame>From Baseline to Week 24</time_frame>
    <description>Adjusted means and standard errors at Week 12 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis</measure>
    <time_frame>From Baseline to Week 24</time_frame>
    <description>Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">355</enrollment>
  <condition>Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>Atorvastatin 40 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ezetimibe 10 mg + Atorvastatin 20 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atorvastatin 80 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rosuvastatin 40 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ezetimibe 10 mg + Atorvastatin 40 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Alirocumab 75 mg/ up to 150 mg + Atorvastatin 40 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alirocumab</intervention_name>
    <description>Alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.</description>
    <arm_group_label>Alirocumab 75 mg/ up to 150 mg + Atorvastatin 40 mg</arm_group_label>
    <arm_group_label>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</arm_group_label>
    <other_name>REGN727/SAR236553</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin</intervention_name>
    <description>Atorvastatin over-encapsulated tablets orally.</description>
    <arm_group_label>Alirocumab 75 mg/ up to 150 mg + Atorvastatin 40 mg</arm_group_label>
    <arm_group_label>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</arm_group_label>
    <arm_group_label>Atorvastatin 40 mg</arm_group_label>
    <arm_group_label>Atorvastatin 80 mg</arm_group_label>
    <arm_group_label>Ezetimibe 10 mg + Atorvastatin 20 mg</arm_group_label>
    <arm_group_label>Ezetimibe 10 mg + Atorvastatin 40 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ezetimibe</intervention_name>
    <description>Ezetimibe over-encapsulated tablet orally.</description>
    <arm_group_label>Ezetimibe 10 mg + Atorvastatin 20 mg</arm_group_label>
    <arm_group_label>Ezetimibe 10 mg + Atorvastatin 40 mg</arm_group_label>
    <other_name>Ezetrol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin</intervention_name>
    <description>Rosuvastatin over-encapsulated tablets orally.</description>
    <arm_group_label>Rosuvastatin 40 mg</arm_group_label>
    <other_name>Crestor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo for alirocumab and ezetimibe.</description>
    <arm_group_label>Alirocumab 75 mg/ up to 150 mg + Atorvastatin 40 mg</arm_group_label>
    <arm_group_label>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</arm_group_label>
    <arm_group_label>Atorvastatin 40 mg</arm_group_label>
    <arm_group_label>Atorvastatin 80 mg</arm_group_label>
    <arm_group_label>Ezetimibe 10 mg + Atorvastatin 20 mg</arm_group_label>
    <arm_group_label>Ezetimibe 10 mg + Atorvastatin 40 mg</arm_group_label>
    <arm_group_label>Rosuvastatin 40 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with screening (visit 1) LDL-C greater than or equal to 70 mg/dL with&#xD;
             documented CVD, not adequately controlled with a daily dose of atorvastatin. OR&#xD;
&#xD;
          2. Patients with screening (visit 1) LDL-C greater than or equal to 100 mg/dL at high&#xD;
             risk for CVD who are not adequately controlled with a daily dose of atorvastatin.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. LDL-C greater than 250 mg/dL&#xD;
&#xD;
          2. LDL-C less than 70 mg/dL at the screening visit in patients with history of documented&#xD;
             CVD&#xD;
&#xD;
          3. LDL-C less than 100 mg/dL at the screening visit in patients without history of&#xD;
             documented CHD or non-CHD CVD, but with other risk factors&#xD;
&#xD;
          4. TG greater than 400 mg/dL&#xD;
&#xD;
          5. Homozygous FH (clinically or previous genotyping)&#xD;
&#xD;
          6. Currently taking a statin that is not atorvastatin&#xD;
&#xD;
          7. Currently taking Ezetimibe (EZE)&#xD;
&#xD;
          8. Not on a stable dose of allowable lipid modifying treatments (LMT)&#xD;
&#xD;
        (The inclusion/ exclusion criteria provided above is not intended to contain all&#xD;
        considerations relevant to a patient's potential participation in this clinical trial).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trial Management</last_name>
    <role>Study Director</role>
    <affiliation>Regeneron Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lakeland</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Milford</city>
        <state>Connecticut</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Atlantis</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami (2 locations)</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oviedo</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pinellas Park</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Morton</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Newton</city>
        <state>Kansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Auburn</city>
        <state>Maine</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Olive Branch</city>
        <state>Mississippi</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Port Gibson</city>
        <state>Mississippi</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Butte</city>
        <state>Montana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Williamsville</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Summerville</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dallas (2 locations)</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bountiful</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Marion</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Renton</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Herston QLD</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Lambton Heights</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Perth</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sherwood</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Woolloongabba</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brampton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Etobicoke</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Newmarke</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Thornhill</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicoutimi</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Venissieux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bad Oeynhausen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Koeln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Munich</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Regensburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chiete</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Genova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Palermo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Roma (2 locations)</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Distrito Federal</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Guadalajara, Jalisco</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Guadalajara</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Monterrey Nuevo Leon</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tijuana Baja California</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Zapopan Jalisco</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Barcelona (3 locations)</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sant Joan Despi</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Carmarthen</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Peterborough</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stevenage</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>West Bromwich, West Midlands</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Mexico</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <results_first_submitted>July 29, 2015</results_first_submitted>
  <results_first_submitted_qc>July 29, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 31, 2015</results_first_posted>
  <disposition_first_submitted>January 24, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>January 24, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">February 2, 2015</disposition_first_posted>
  <last_update_submitted>July 29, 2015</last_update_submitted>
  <last_update_submitted_qc>July 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypercholesterolemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atorvastatin</mesh_term>
    <mesh_term>Rosuvastatin Calcium</mesh_term>
    <mesh_term>Ezetimibe</mesh_term>
    <mesh_term>Alirocumab</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at 85 sites in 9 countries. Overall, 859 subjects were screened between 24 October 2012 and 26 September 2013, 504 of whom were screen failures. Screen failures ware mainly due to exclusion criteria met.</recruitment_details>
      <pre_assignment_details>Randomization was stratified according to prior history of myocardial infarction or ischemic stroke, and intensity of statin treatment (atorvastatin 20 or 40 mg). Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1:1:1:1:1:1 ratio after confirmation of selection criteria.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Atorvastatin 40 mg</title>
          <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
          <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
          <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
        </group>
        <group group_id="P4">
          <title>Atorvastatin 80 mg</title>
          <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
        </group>
        <group group_id="P5">
          <title>Rosuvastatin 40 mg</title>
          <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
        </group>
        <group group_id="P6">
          <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
          <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
        </group>
        <group group_id="P7">
          <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
          <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="55"/>
                <participants group_id="P3" count="57"/>
                <participants group_id="P4" count="47"/>
                <participants group_id="P5" count="45"/>
                <participants group_id="P6" count="47"/>
                <participants group_id="P7" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="55"/>
                <participants group_id="P3" count="57"/>
                <participants group_id="P4" count="47"/>
                <participants group_id="P5" count="45"/>
                <participants group_id="P6" count="46"/>
                <participants group_id="P7" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="46"/>
                <participants group_id="P4" count="39"/>
                <participants group_id="P5" count="39"/>
                <participants group_id="P6" count="40"/>
                <participants group_id="P7" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="7"/>
                <participants group_id="P7" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Randomized but not treated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject moved</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other than specified</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Poor compliance to protocol</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Atorvastatin 40 mg</title>
          <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
          <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
          <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
        </group>
        <group group_id="B4">
          <title>Atorvastatin 80 mg</title>
          <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
        </group>
        <group group_id="B5">
          <title>Rosuvastatin 40 mg</title>
          <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
        </group>
        <group group_id="B6">
          <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
          <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
        </group>
        <group group_id="B7">
          <title>Alirocumab 75 mg/ up to 150 mg + Atorvastatin 40 mg</title>
          <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
        </group>
        <group group_id="B8">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="57"/>
            <count group_id="B2" value="55"/>
            <count group_id="B3" value="57"/>
            <count group_id="B4" value="47"/>
            <count group_id="B5" value="45"/>
            <count group_id="B6" value="47"/>
            <count group_id="B7" value="47"/>
            <count group_id="B8" value="355"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63" spread="9.91"/>
                    <measurement group_id="B2" value="65.7" spread="8.96"/>
                    <measurement group_id="B3" value="62.2" spread="10.03"/>
                    <measurement group_id="B4" value="63.2" spread="10.89"/>
                    <measurement group_id="B5" value="57.5" spread="9.96"/>
                    <measurement group_id="B6" value="63.9" spread="10.33"/>
                    <measurement group_id="B7" value="64.2" spread="10.36"/>
                    <measurement group_id="B8" value="62.9" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="13"/>
                    <measurement group_id="B6" value="11"/>
                    <measurement group_id="B7" value="16"/>
                    <measurement group_id="B8" value="124"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="33"/>
                    <measurement group_id="B5" value="32"/>
                    <measurement group_id="B6" value="36"/>
                    <measurement group_id="B7" value="31"/>
                    <measurement group_id="B8" value="231"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Low density lipoprotein cholesterol (LDL-C) in mg/dL</title>
          <description>Calculated LDL-C from Friedewald formula.</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="100.3" spread="29.8"/>
                    <measurement group_id="B2" value="100.4" spread="29.5"/>
                    <measurement group_id="B3" value="103.9" spread="34.9"/>
                    <measurement group_id="B4" value="108.6" spread="37.5"/>
                    <measurement group_id="B5" value="109.8" spread="39.0"/>
                    <measurement group_id="B6" value="98.9" spread="29.2"/>
                    <measurement group_id="B7" value="116.4" spread="37.4"/>
                    <measurement group_id="B8" value="105.1" spread="34.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>LDL-C in mmol/L</title>
          <description>Calculated LDL-C from Friedewald formula.</description>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.957" spread="0.773"/>
                    <measurement group_id="B2" value="2.599" spread="0.765"/>
                    <measurement group_id="B3" value="2.692" spread="0.905"/>
                    <measurement group_id="B4" value="2.813" spread="0.97"/>
                    <measurement group_id="B5" value="2.844" spread="1.011"/>
                    <measurement group_id="B6" value="2.562" spread="0.756"/>
                    <measurement group_id="B7" value="3.016" spread="0.968"/>
                    <measurement group_id="B8" value="2.723" spread="0.884"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis</title>
        <description>Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).</description>
        <time_frame>From Baseline to Week 24</time_frame>
        <population>ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis</title>
          <description>Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).</description>
          <population>ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="46"/>
                <count group_id="O7" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5" spread="4.6"/>
                    <measurement group_id="O2" value="-20.5" spread="4.7"/>
                    <measurement group_id="O3" value="-44.1" spread="4.5"/>
                    <measurement group_id="O4" value="-4.8" spread="4.2"/>
                    <measurement group_id="O5" value="-21.4" spread="4.2"/>
                    <measurement group_id="O6" value="-22.6" spread="4.3"/>
                    <measurement group_id="O7" value="-54" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Alirocumab group was compared to the corresponding active control group using an appropriate contrast statement.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Threshold for significance ≤ 0.01.</method_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>-39.1</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-55.9</ci_lower_limit>
            <ci_upper_limit>-22.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>As described in statistical analysis 1 of the endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>= 0.0004</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-23.6</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-40.7</ci_lower_limit>
            <ci_upper_limit>-6.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-49.2</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-65</ci_lower_limit>
            <ci_upper_limit>-33.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-32.6</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-48.4</ci_lower_limit>
            <ci_upper_limit>-16.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-31.4</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-47.4</ci_lower_limit>
            <ci_upper_limit>-15.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis</title>
        <description>Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).</description>
        <time_frame>From Baseline to Week 24</time_frame>
        <population>Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis</title>
          <description>Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).</description>
          <population>Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="46"/>
                <count group_id="O7" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.1" spread="4.6"/>
                    <measurement group_id="O2" value="-23.7" spread="4.7"/>
                    <measurement group_id="O3" value="-48.6" spread="4.5"/>
                    <measurement group_id="O4" value="-5.0" spread="4.4"/>
                    <measurement group_id="O5" value="-22.9" spread="4.4"/>
                    <measurement group_id="O6" value="-24.5" spread="4.5"/>
                    <measurement group_id="O7" value="-57.8" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 1% level.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-42.5</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-59.2</ci_lower_limit>
            <ci_upper_limit>-25.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>= 0.0002</p_value>
            <p_value_desc>Threshold for significance≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-24.9</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-41.9</ci_lower_limit>
            <ci_upper_limit>-7.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-52.8</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-69.2</ci_lower_limit>
            <ci_upper_limit>-36.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Threshold for significance ≤ 0.01.</method_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>-35.0</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-51.3</ci_lower_limit>
            <ci_upper_limit>-18.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-33.4</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-50.0</ci_lower_limit>
            <ci_upper_limit>-16.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis</title>
        <description>Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment (ITT analysis).</description>
        <time_frame>From Baseline to Week 24</time_frame>
        <population>ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis</title>
          <description>Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment (ITT analysis).</description>
          <population>ITT population.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="46"/>
                <count group_id="O7" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.5" spread="3.9"/>
                    <measurement group_id="O2" value="-22.6" spread="3.9"/>
                    <measurement group_id="O3" value="-48.4" spread="3.8"/>
                    <measurement group_id="O4" value="-14.5" spread="3.2"/>
                    <measurement group_id="O5" value="-23.3" spread="3.2"/>
                    <measurement group_id="O6" value="-29.7" spread="3.2"/>
                    <measurement group_id="O7" value="-50.5" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-39.8</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-54</ci_lower_limit>
            <ci_upper_limit>-25.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-25.8</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-40.0</ci_lower_limit>
            <ci_upper_limit>-11.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-36.0</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-47.7</ci_lower_limit>
            <ci_upper_limit>-24.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-27.3</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-39.2</ci_lower_limit>
            <ci_upper_limit>-15.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-20.9</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-32.8</ci_lower_limit>
            <ci_upper_limit>-8.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis</title>
        <description>Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).</description>
        <time_frame>From Baseline to Week 24</time_frame>
        <population>mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis</title>
          <description>Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).</description>
          <population>mITT population.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="46"/>
                <count group_id="O7" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.2" spread="3.1"/>
                    <measurement group_id="O2" value="-27.1" spread="3.1"/>
                    <measurement group_id="O3" value="-53.7" spread="3.1"/>
                    <measurement group_id="O4" value="-14.6" spread="3.2"/>
                    <measurement group_id="O5" value="-23.3" spread="3.2"/>
                    <measurement group_id="O6" value="-30.7" spread="3.2"/>
                    <measurement group_id="O7" value="-50.9" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-44.5</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-55.8</ci_lower_limit>
            <ci_upper_limit>-33.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-26.6</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-38.0</ci_lower_limit>
            <ci_upper_limit>-15.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-36.3</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-48.1</ci_lower_limit>
            <ci_upper_limit>-24.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-27.7</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-39.6</ci_lower_limit>
            <ci_upper_limit>-15.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-20.2</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-32.2</ci_lower_limit>
            <ci_upper_limit>-8.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis</title>
        <description>Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
        <time_frame>From Baseline to Week 24</time_frame>
        <population>Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis</title>
          <description>Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
          <population>Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="53"/>
                <count group_id="O4" value="45"/>
                <count group_id="O5" value="44"/>
                <count group_id="O6" value="45"/>
                <count group_id="O7" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.4" spread="3.5"/>
                    <measurement group_id="O2" value="-10.1" spread="3.6"/>
                    <measurement group_id="O3" value="-33.7" spread="3.4"/>
                    <measurement group_id="O4" value="-3.5" spread="3.3"/>
                    <measurement group_id="O5" value="-10.9" spread="3.2"/>
                    <measurement group_id="O6" value="-14.3" spread="3.3"/>
                    <measurement group_id="O7" value="-41.9" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-29.3</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-42.0</ci_lower_limit>
            <ci_upper_limit>-16.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-23.6</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-36.6</ci_lower_limit>
            <ci_upper_limit>-10.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-38.4</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-50.8</ci_lower_limit>
            <ci_upper_limit>-26.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-30.9</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-43.2</ci_lower_limit>
            <ci_upper_limit>-18.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-27.6</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-40.1</ci_lower_limit>
            <ci_upper_limit>-15.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis</title>
        <description>Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first).</description>
        <time_frame>From Baseline to Week 24</time_frame>
        <population>Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis</title>
          <description>Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first).</description>
          <population>Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="47"/>
                <count group_id="O3" value="50"/>
                <count group_id="O4" value="44"/>
                <count group_id="O5" value="44"/>
                <count group_id="O6" value="44"/>
                <count group_id="O7" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.1" spread="3.3"/>
                    <measurement group_id="O2" value="-12.6" spread="3.5"/>
                    <measurement group_id="O3" value="-37.7" spread="3.2"/>
                    <measurement group_id="O4" value="-4.4" spread="3.4"/>
                    <measurement group_id="O5" value="-12.8" spread="3.4"/>
                    <measurement group_id="O6" value="-16.3" spread="3.4"/>
                    <measurement group_id="O7" value="-42.7" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-32.6</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-44.6</ci_lower_limit>
            <ci_upper_limit>-20.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-25.1</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-37.3</ci_lower_limit>
            <ci_upper_limit>-12.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-38.3</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-51.2</ci_lower_limit>
            <ci_upper_limit>-25.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-29.8</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-42.6</ci_lower_limit>
            <ci_upper_limit>-17.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-26.4</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-39.4</ci_lower_limit>
            <ci_upper_limit>-13.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis</title>
        <description>Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
        <time_frame>From Baseline to Week 24</time_frame>
        <population>Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis</title>
          <description>Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
          <population>Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="46"/>
                <count group_id="O7" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.3" spread="3.9"/>
                    <measurement group_id="O2" value="-15.1" spread="4.0"/>
                    <measurement group_id="O3" value="-36.7" spread="3.9"/>
                    <measurement group_id="O4" value="-6.5" spread="3.6"/>
                    <measurement group_id="O5" value="-17.4" spread="3.6"/>
                    <measurement group_id="O6" value="-21.0" spread="3.7"/>
                    <measurement group_id="O7" value="-47.6" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-30.4</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-44.7</ci_lower_limit>
            <ci_upper_limit>-16.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>=0.0002</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-21.6</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-36.1</ci_lower_limit>
            <ci_upper_limit>-7.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-41.1</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-54.7</ci_lower_limit>
            <ci_upper_limit>-27.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-30.2</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-43.7</ci_lower_limit>
            <ci_upper_limit>-16.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-26.6</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-40.3</ci_lower_limit>
            <ci_upper_limit>-12.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis</title>
        <description>Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first).</description>
        <time_frame>From Baseline to Week 24</time_frame>
        <population>Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C value on-treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis</title>
          <description>Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first).</description>
          <population>Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C value on-treatment.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="46"/>
                <count group_id="O7" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.5" spread="3.8"/>
                    <measurement group_id="O2" value="-18.1" spread="4.0"/>
                    <measurement group_id="O3" value="-40.5" spread="3.7"/>
                    <measurement group_id="O4" value="-7.0" spread="3.7"/>
                    <measurement group_id="O5" value="-18.4" spread="3.7"/>
                    <measurement group_id="O6" value="-23.3" spread="3.8"/>
                    <measurement group_id="O7" value="-50.5" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-33.0</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-47.0</ci_lower_limit>
            <ci_upper_limit>-19.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-22.4</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-36.6</ci_lower_limit>
            <ci_upper_limit>-8.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-43.6</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-57.4</ci_lower_limit>
            <ci_upper_limit>-29.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-32.1</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-46.0</ci_lower_limit>
            <ci_upper_limit>-18.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-27.3</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-41.4</ci_lower_limit>
            <ci_upper_limit>-13.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis</title>
        <description>Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
        <time_frame>From Baseline to Week 24</time_frame>
        <population>Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis</title>
          <description>Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
          <population>Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="46"/>
                <count group_id="O7" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.0" spread="2.7"/>
                    <measurement group_id="O2" value="-11.2" spread="2.8"/>
                    <measurement group_id="O3" value="-27.1" spread="2.7"/>
                    <measurement group_id="O4" value="-4.8" spread="2.8"/>
                    <measurement group_id="O5" value="-11.7" spread="2.8"/>
                    <measurement group_id="O6" value="-15.2" spread="2.9"/>
                    <measurement group_id="O7" value="-33.6" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-23.1</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-32.9</ci_lower_limit>
            <ci_upper_limit>-13.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-15.8</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-25.8</ci_lower_limit>
            <ci_upper_limit>-5.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-28.9</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-39.4</ci_lower_limit>
            <ci_upper_limit>-18.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-21.9</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-32.4</ci_lower_limit>
            <ci_upper_limit>-11.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-18.4</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-29.1</ci_lower_limit>
            <ci_upper_limit>-7.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Apo B at Week 12 - ITT Analysis</title>
        <description>Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
        <time_frame>From Baseline to Week 24</time_frame>
        <population>Apo B ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Apo B at Week 12 - ITT Analysis</title>
          <description>Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
          <population>Apo B ITT population.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="53"/>
                <count group_id="O4" value="45"/>
                <count group_id="O5" value="44"/>
                <count group_id="O6" value="45"/>
                <count group_id="O7" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.9" spread="2.8"/>
                    <measurement group_id="O2" value="-13.1" spread="2.8"/>
                    <measurement group_id="O3" value="-38.4" spread="2.7"/>
                    <measurement group_id="O4" value="-9.5" spread="2.5"/>
                    <measurement group_id="O5" value="-14.1" spread="2.5"/>
                    <measurement group_id="O6" value="-20.3" spread="2.5"/>
                    <measurement group_id="O7" value="-36.2" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-31.5</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-41.6</ci_lower_limit>
            <ci_upper_limit>-21.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-25.3</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-35.4</ci_lower_limit>
            <ci_upper_limit>-15.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-26.7</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-35.9</ci_lower_limit>
            <ci_upper_limit>-17.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-22.2</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-31.5</ci_lower_limit>
            <ci_upper_limit>-12.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-15.9</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-25.2</ci_lower_limit>
            <ci_upper_limit>-6.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis</title>
        <description>Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
        <time_frame>From Baseline to Week 24</time_frame>
        <population>Non-HDL-C ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis</title>
          <description>Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
          <population>Non-HDL-C ITT population.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="46"/>
                <count group_id="O7" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.1" spread="3.2"/>
                    <measurement group_id="O2" value="-17.2" spread="3.2"/>
                    <measurement group_id="O3" value="-40.6" spread="3.2"/>
                    <measurement group_id="O4" value="-13.0" spread="2.6"/>
                    <measurement group_id="O5" value="-19.8" spread="2.7"/>
                    <measurement group_id="O6" value="-27.5" spread="2.7"/>
                    <measurement group_id="O7" value="-42.3" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-33.5</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-45.3</ci_lower_limit>
            <ci_upper_limit>-21.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-23.4</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-35.2</ci_lower_limit>
            <ci_upper_limit>-11.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-29.3</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-39.0</ci_lower_limit>
            <ci_upper_limit>-19.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-22.5</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-32.3</ci_lower_limit>
            <ci_upper_limit>-12.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-14.8</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.7</ci_lower_limit>
            <ci_upper_limit>-4.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Total-C at Week 12 - ITT Analysis</title>
        <description>Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
        <time_frame>From Baseline to Week 24</time_frame>
        <population>Total-C ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Total-C at Week 12 - ITT Analysis</title>
          <description>Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
          <population>Total-C ITT population.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="46"/>
                <count group_id="O7" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.5" spread="2.4"/>
                    <measurement group_id="O2" value="-13.2" spread="2.4"/>
                    <measurement group_id="O3" value="-29.0" spread="2.4"/>
                    <measurement group_id="O4" value="-9.9" spread="2.1"/>
                    <measurement group_id="O5" value="-13.5" spread="2.1"/>
                    <measurement group_id="O6" value="-19.2" spread="2.1"/>
                    <measurement group_id="O7" value="-29.0" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-22.6</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-31.4</ci_lower_limit>
            <ci_upper_limit>-13.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-15.8</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.6</ci_lower_limit>
            <ci_upper_limit>-7.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-19.1</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-26.9</ci_lower_limit>
            <ci_upper_limit>-11.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-15.4</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23.3</ci_lower_limit>
            <ci_upper_limit>-7.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>=0.0015</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-9.8</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.7</ci_lower_limit>
            <ci_upper_limit>-1.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Very High CV Risk Participants Reaching Calculated LDL-C &lt;70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C &lt;100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis</title>
        <description>Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).</description>
        <time_frame>Up to Week 24</time_frame>
        <population>ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Very High CV Risk Participants Reaching Calculated LDL-C &lt;70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C &lt;100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis</title>
          <description>Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).</description>
          <population>ITT population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="46"/>
                <count group_id="O7" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.5"/>
                    <measurement group_id="O2" value="68.4"/>
                    <measurement group_id="O3" value="87.2"/>
                    <measurement group_id="O4" value="18.5"/>
                    <measurement group_id="O5" value="62.2"/>
                    <measurement group_id="O6" value="65.1"/>
                    <measurement group_id="O7" value="84.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>16.7</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.9</ci_lower_limit>
            <ci_upper_limit>71.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>=0.0284</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.4</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.8</ci_lower_limit>
            <ci_upper_limit>14.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>83.2</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.6</ci_lower_limit>
            <ci_upper_limit>596.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>=0.0025</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>7.2</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.3</ci_lower_limit>
            <ci_upper_limit>38.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>=0.0011</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>9.1</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.6</ci_lower_limit>
            <ci_upper_limit>52.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Very High CV Risk Participants Reaching Calculated LDL-C &lt;70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C &lt;100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis</title>
        <description>Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).</description>
        <time_frame>Up to Week 24</time_frame>
        <population>mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Very High CV Risk Participants Reaching Calculated LDL-C &lt;70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C &lt;100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis</title>
          <description>Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).</description>
          <population>mITT population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="46"/>
                <count group_id="O7" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.8"/>
                    <measurement group_id="O2" value="72.2"/>
                    <measurement group_id="O3" value="91.2"/>
                    <measurement group_id="O4" value="18.5"/>
                    <measurement group_id="O5" value="64.0"/>
                    <measurement group_id="O6" value="66.2"/>
                    <measurement group_id="O7" value="90.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>128.4</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>14.2</ci_lower_limit>
            <ci_upper_limit>1157</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>=0.0015</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>10.9</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.6</ci_lower_limit>
            <ci_upper_limit>75.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>=0.0008</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>13.7</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.8</ci_lower_limit>
            <ci_upper_limit>101.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Reaching Calculated LDL-C &lt;70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis</title>
        <description>Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).</description>
        <time_frame>Up to Week 24</time_frame>
        <population>ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Reaching Calculated LDL-C &lt;70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis</title>
          <description>Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).</description>
          <population>ITT population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="46"/>
                <count group_id="O7" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.0"/>
                    <measurement group_id="O2" value="50.3"/>
                    <measurement group_id="O3" value="79.2"/>
                    <measurement group_id="O4" value="10.2"/>
                    <measurement group_id="O5" value="42.2"/>
                    <measurement group_id="O6" value="54.2"/>
                    <measurement group_id="O7" value="77.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>116.8</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>14.7</ci_lower_limit>
            <ci_upper_limit>927.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>13.2</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.5</ci_lower_limit>
            <ci_upper_limit>68.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>=0.0004</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>9.9</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.9</ci_lower_limit>
            <ci_upper_limit>51.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Reaching Calculated LDL-C &lt;70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis</title>
        <description>Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).</description>
        <time_frame>Up to Week 24</time_frame>
        <population>mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Reaching Calculated LDL-C &lt;70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis</title>
          <description>Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).</description>
          <population>mITT population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="46"/>
                <count group_id="O7" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0"/>
                    <measurement group_id="O2" value="55.1"/>
                    <measurement group_id="O3" value="82.3"/>
                    <measurement group_id="O4" value="10.5"/>
                    <measurement group_id="O5" value="42.4"/>
                    <measurement group_id="O6" value="55.3"/>
                    <measurement group_id="O7" value="83.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>162.1</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>17.3</ci_lower_limit>
            <ci_upper_limit>1520.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>19.8</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.1</ci_lower_limit>
            <ci_upper_limit>126.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>=0.0002</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>13.9</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.2</ci_lower_limit>
            <ci_upper_limit>88.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis</title>
        <description>Adjusted means and standard errors at Week 24 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
        <time_frame>From Baseline to Week 24</time_frame>
        <population>Participants analyzed: participants of the ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis</title>
          <description>Adjusted means and standard errors at Week 24 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
          <population>Participants analyzed: participants of the ITT population.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="46"/>
                <count group_id="O7" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.2" spread="4.0"/>
                    <measurement group_id="O2" value="-10.6" spread="4.4"/>
                    <measurement group_id="O3" value="-23.6" spread="4.0"/>
                    <measurement group_id="O4" value="-9.7" spread="4.1"/>
                    <measurement group_id="O5" value="-4.9" spread="3.7"/>
                    <measurement group_id="O6" value="0.2" spread="3.9"/>
                    <measurement group_id="O7" value="-30.8" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a robust regression model.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>=0.0004</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Regression, Robust</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-21.1</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-36.3</ci_lower_limit>
            <ci_upper_limit>-5.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Regression, Robust</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-25.9</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-40.2</ci_lower_limit>
            <ci_upper_limit>-11.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Analysis description as per the statistical analysis 1 of this endpoint.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Regression, Robust</method>
            <param_type>Adjusted Mean Difference</param_type>
            <param_value>-31.0</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-45.6</ci_lower_limit>
            <ci_upper_limit>-16.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis</title>
        <description>Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
        <time_frame>From Baseline to Week 24</time_frame>
        <population>Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis</title>
          <description>Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
          <population>Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="46"/>
                <count group_id="O7" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="2.0"/>
                    <measurement group_id="O2" value="-0.1" spread="2.1"/>
                    <measurement group_id="O3" value="4.8" spread="2.0"/>
                    <measurement group_id="O4" value="4.7" spread="2.7"/>
                    <measurement group_id="O5" value="5.7" spread="2.7"/>
                    <measurement group_id="O6" value="2.0" spread="2.7"/>
                    <measurement group_id="O7" value="7.7" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>=0.4456</p_value>
            <p_value_desc>Threshold for significance ≤ 0.01.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>2.9</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.0</ci_lower_limit>
            <ci_upper_limit>12.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis</title>
        <description>Adjusted means and standard errors at Week 24 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
        <time_frame>From Baseline to Week 24</time_frame>
        <population>ITT population: all randomized and treated participants with one baseline and at least one post-baseline fasting triglycerides value on- or off-treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis</title>
          <description>Adjusted means and standard errors at Week 24 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
          <population>ITT population: all randomized and treated participants with one baseline and at least one post-baseline fasting triglycerides value on- or off-treatment.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="46"/>
                <count group_id="O7" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.7" spread="3.7"/>
                    <measurement group_id="O2" value="-3.3" spread="4.1"/>
                    <measurement group_id="O3" value="-12.0" spread="3.7"/>
                    <measurement group_id="O4" value="-7.3" spread="4.1"/>
                    <measurement group_id="O5" value="-0.5" spread="4.0"/>
                    <measurement group_id="O6" value="-13.9" spread="4.1"/>
                    <measurement group_id="O7" value="-19.1" spread="4.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis</title>
        <description>Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
        <time_frame>From Baseline to Week 24</time_frame>
        <population>Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis</title>
          <description>Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
          <population>Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="53"/>
                <count group_id="O4" value="45"/>
                <count group_id="O5" value="44"/>
                <count group_id="O6" value="45"/>
                <count group_id="O7" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="1.5"/>
                    <measurement group_id="O2" value="1.0" spread="1.6"/>
                    <measurement group_id="O3" value="7.6" spread="1.5"/>
                    <measurement group_id="O4" value="2.2" spread="2.0"/>
                    <measurement group_id="O5" value="4.7" spread="1.9"/>
                    <measurement group_id="O6" value="-1.8" spread="1.9"/>
                    <measurement group_id="O7" value="5.8" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis</title>
        <description>Adjusted means and standard errors at Week 12 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
        <time_frame>From Baseline to Week 24</time_frame>
        <population>Lipoprotein (a) ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis</title>
          <description>Adjusted means and standard errors at Week 12 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
          <population>Lipoprotein (a) ITT population.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="46"/>
                <count group_id="O7" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.7" spread="4.0"/>
                    <measurement group_id="O2" value="-5.4" spread="4.0"/>
                    <measurement group_id="O3" value="-24.0" spread="4.0"/>
                    <measurement group_id="O4" value="-1.6" spread="4.5"/>
                    <measurement group_id="O5" value="11.5" spread="4.6"/>
                    <measurement group_id="O6" value="7.9" spread="4.5"/>
                    <measurement group_id="O7" value="-27.9" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis</title>
        <description>Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
        <time_frame>From Baseline to Week 24</time_frame>
        <population>HDL-C ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis</title>
          <description>Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
          <population>HDL-C ITT population.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="46"/>
                <count group_id="O7" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.2" spread="1.8"/>
                    <measurement group_id="O2" value="-1.7" spread="1.8"/>
                    <measurement group_id="O3" value="4.1" spread="1.8"/>
                    <measurement group_id="O4" value="3.0" spread="2.6"/>
                    <measurement group_id="O5" value="4.6" spread="2.7"/>
                    <measurement group_id="O6" value="4.6" spread="2.7"/>
                    <measurement group_id="O7" value="8.5" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis</title>
        <description>Adjusted means and standard errors at Week 12 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
        <time_frame>From Baseline to Week 24</time_frame>
        <population>ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis</title>
          <description>Adjusted means and standard errors at Week 12 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
          <population>ITT population.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="55"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="46"/>
                <count group_id="O7" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.7" spread="4.2"/>
                    <measurement group_id="O2" value="0.5" spread="4.2"/>
                    <measurement group_id="O3" value="-12.4" spread="4.2"/>
                    <measurement group_id="O4" value="-4.6" spread="4.0"/>
                    <measurement group_id="O5" value="-3.7" spread="4.1"/>
                    <measurement group_id="O6" value="-16.8" spread="4.0"/>
                    <measurement group_id="O7" value="-12.1" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis</title>
        <description>Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
        <time_frame>From Baseline to Week 24</time_frame>
        <population>Apo A-1 ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
            <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
          <group group_id="O4">
            <title>Atorvastatin 80 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Rosuvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
            <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis</title>
          <description>Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.</description>
          <population>Apo A-1 ITT population.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="53"/>
                <count group_id="O4" value="45"/>
                <count group_id="O5" value="44"/>
                <count group_id="O6" value="45"/>
                <count group_id="O7" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="1.5"/>
                    <measurement group_id="O2" value="1.7" spread="1.4"/>
                    <measurement group_id="O3" value="5.4" spread="1.4"/>
                    <measurement group_id="O4" value="1.6" spread="1.7"/>
                    <measurement group_id="O5" value="5.6" spread="1.7"/>
                    <measurement group_id="O6" value="1.6" spread="1.7"/>
                    <measurement group_id="O7" value="9.4" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Baseline up to Week 24</time_frame>
      <desc>Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.</desc>
      <group_list>
        <group group_id="E1">
          <title>Atorvastatin 40 mg</title>
          <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Ezetimibe 10 mg + Atorvastatin 20 mg</title>
          <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg</title>
          <description>Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up¬-titrated to 150 mg Q2W from Week 12 when LDL-¬C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
        </group>
        <group group_id="E4">
          <title>Atorvastatin 80 mg</title>
          <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
        </group>
        <group group_id="E5">
          <title>Rosuvastatin 40 mg</title>
          <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.</description>
        </group>
        <group group_id="E6">
          <title>Ezetimibe 10 mg + Atorvastatin 40 mg</title>
          <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection.Q2W added to stable LMT for 24 weeks.</description>
        </group>
        <group group_id="E7">
          <title>Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg</title>
          <description>Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>meddra (17.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Non-Cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Seroma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Intraductal proliferative breast lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>meddra (17.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="18" subjects_at_risk="47"/>
                <counts group_id="E5" subjects_affected="23" subjects_at_risk="45"/>
                <counts group_id="E6" subjects_affected="12" subjects_at_risk="46"/>
                <counts group_id="E7" subjects_affected="19" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E5" events="6" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="57"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="47"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="5" subjects_affected="4" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="55"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E6" events="6" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="57"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="55"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="4" subjects_affected="3" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="5" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="57"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="57"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="4" subjects_affected="4" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="57"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E5" events="6" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E6" events="6" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Not less than 45 days prior to submission for publication or presentation, the Institution shall, or cause the Principal Investigator to, provide the Sponsor with a copy of the Manuscript. The Institution shall consider in good faith any comments from the Sponsor regarding the content, and shall delete Confidential Information upon written request of the Sponsor. At the Sponsor's request, the Institution shall delay publication for an additional 60 days to allow patent applications to be filed.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trial Management</name_or_title>
      <organization>Regeneron Pharmaceuticals, Inc</organization>
      <email>clinicaltrials@regeneron.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01730040
org study id: R727-CL-1110
nct id: NCT01730040
lead sponsor: 
collaborator: 
has dmc: Yes
This is a randomized, double-blind, active-comparator, parallel-group study in patients at
      high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial
      hypercholesterolemia (heFH).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis
time frame: From Baseline to Week 24
description: Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).
measure: Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis
time frame: From Baseline to Week 24
description: Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).
measure: Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
time frame: From Baseline to Week 24
description: Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment (ITT analysis).
measure: Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis
time frame: From Baseline to Week 24
description: Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).
measure: Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis
time frame: From Baseline to Week 24
description: Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
measure: Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis
time frame: From Baseline to Week 24
description: Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first).
measure: Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis
time frame: From Baseline to Week 24
description: Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
measure: Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis
time frame: From Baseline to Week 24
description: Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first).
measure: Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis
time frame: From Baseline to Week 24
description: Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
measure: Percent Change From Baseline in Apo B at Week 12 - ITT Analysis
time frame: From Baseline to Week 24
description: Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
measure: Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis
time frame: From Baseline to Week 24
description: Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
measure: Percent Change From Baseline in Total-C at Week 12 - ITT Analysis
time frame: From Baseline to Week 24
description: Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
measure: Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis
time frame: Up to Week 24
description: Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).
measure: Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis
time frame: Up to Week 24
description: Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).
measure: Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis
time frame: Up to Week 24
description: Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).
measure: Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis
time frame: Up to Week 24
description: Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).
measure: Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis
time frame: From Baseline to Week 24
description: Adjusted means and standard errors at Week 24 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
measure: Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis
time frame: From Baseline to Week 24
description: Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
measure: Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
time frame: From Baseline to Week 24
description: Adjusted means and standard errors at Week 24 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
measure: Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis
time frame: From Baseline to Week 24
description: Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
measure: Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis
time frame: From Baseline to Week 24
description: Adjusted means and standard errors at Week 12 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
measure: Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis
time frame: From Baseline to Week 24
description: Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
measure: Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
time frame: From Baseline to Week 24
description: Adjusted means and standard errors at Week 12 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
measure: Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis
time frame: From Baseline to Week 24
description: Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
arm group label: Atorvastatin 40 mg
arm group type: Active Comparator
description: Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
arm group label: Ezetimibe 10 mg + Atorvastatin 20 mg
arm group type: Active Comparator
description: Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
arm group label: Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
arm group type: Experimental
description: Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
arm group label: Atorvastatin 80 mg
arm group type: Active Comparator
description: Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
arm group label: Rosuvastatin 40 mg
arm group type: Active Comparator
description: Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
arm group label: Ezetimibe 10 mg + Atorvastatin 40 mg
arm group type: Active Comparator
description: Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
arm group label: Alirocumab 75 mg/ up to 150 mg + Atorvastatin 40 mg
arm group type: Experimental
description: Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
intervention type: Drug
intervention name: Alirocumab
description: Alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.
arm group label: Alirocumab 75 mg/ up to 150 mg + Atorvastatin 40 mg
arm group label: Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
other name: REGN727/SAR236553
intervention type: Drug
intervention name: Atorvastatin
description: Atorvastatin over-encapsulated tablets orally.
arm group label: Alirocumab 75 mg/ up to 150 mg + Atorvastatin 40 mg
arm group label: Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
arm group label: Atorvastatin 40 mg
arm group label: Atorvastatin 80 mg
arm group label: Ezetimibe 10 mg + Atorvastatin 20 mg
arm group label: Ezetimibe 10 mg + Atorvastatin 40 mg
intervention type: Drug
intervention name: Ezetimibe
description: Ezetimibe over-encapsulated tablet orally.
arm group label: Ezetimibe 10 mg + Atorvastatin 20 mg
arm group label: Ezetimibe 10 mg + Atorvastatin 40 mg
other name: Ezetrol
intervention type: Drug
intervention name: Rosuvastatin
description: Rosuvastatin over-encapsulated tablets orally.
arm group label: Rosuvastatin 40 mg
other name: Crestor
intervention type: Drug
intervention name: Placebo
description: Placebo for alirocumab and ezetimibe.
arm group label: Alirocumab 75 mg/ up to 150 mg + Atorvastatin 40 mg
arm group label: Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
arm group label: Atorvastatin 40 mg
arm group label: Atorvastatin 80 mg
arm group label: Ezetimibe 10 mg + Atorvastatin 20 mg
arm group label: Ezetimibe 10 mg + Atorvastatin 40 mg
arm group label: Rosuvastatin 40 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trial Management
role: Study Director
affiliation: Regeneron Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Canada
country: France
country: Germany
country: Italy
country: Mexico
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Hypercholesterolemia
mesh term: Atorvastatin
mesh term: Rosuvastatin Calcium
mesh term: Ezetimibe
mesh term: Alirocumab
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 