<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/NCT02226198</url>
  </required_header>
  <id_info>
    <org_study_id>D3561C00004</org_study_id>
    <nct_id>NCT02226198</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia</brief_title>
  <acronym>HYDRA</acronym>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Multi-center, Cross-over Study of Rosuvastatin in Children and Adolescents (Aged 6 to &lt;18 Years) With Homozygous Familial Hypercholesterolemia (HoFH)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to establish the efficacy, safety and tolerability of&#xD;
      rosuvastatin in children and adolescents with homozygous familial hypercholesterolemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double-blind, placebo-controlled, multi-center, cross-over study of the&#xD;
      efficacy, safety and tolerability rosuvastatin in children and adolescents (aged 6 to &lt;18&#xD;
      years) with homozygous familial hypercholesterolemia (HoFH). The study is designed to assess&#xD;
      the efficacy of rosuvastatin 20 mg compared to placebo on lipids, lipoproteins and&#xD;
      apolipoproteins in pediatric patients with HoFH. The outcome measures to be assessed include&#xD;
      low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C),&#xD;
      total cholesterol (TC), triglycerides, non-HDL-C, LDL-C/HDL-C, TC/HDL-C, non-HDL-C/HDL-C,&#xD;
      apolipoprotein B (ApoB), apolipoprotein A 1 (ApoA-1) and ApoB/ApoA-1 following 6 weeks of&#xD;
      treatment with rosuvastatin 20 mg or placebo. Pharmacokinetic data of the trough plasma&#xD;
      exposure of rosuvastatin will also be assessed in these pediatric patients with HoFH.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>LDL-Cholesterol (mg/dL)</measure>
    <time_frame>Samples taken on Day 42 (week 6) and on day 84 (week 12)</time_frame>
    <description>Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>LDL-Cholesterol (mmol/L)</measure>
    <time_frame>Samples taken on Day 42 (week 6) and on day 84 (week 12)</time_frame>
    <description>Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TC (mg/dL)</measure>
    <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
    <description>Efficacy in terms of total cholesterol (TC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TC (mmol/L)</measure>
    <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
    <description>Efficacy in terms of total cholesterol (TC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-HDL C (mg/dL)</measure>
    <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
    <description>Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-HDL C (mmol/L)</measure>
    <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
    <description>Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ApoB (mg/dL)</measure>
    <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
    <description>Efficacy in terms of apolipoprotein B (ApoB)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ApoB (g/L)</measure>
    <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
    <description>Efficacy in terms of apolipoprotein B (ApoB)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL-C (mg/dL)</measure>
    <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
    <description>Efficacy in terms of high density lipoprotein cholesterol (HDL C)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL-C (mmol/L)</measure>
    <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
    <description>Efficacy in terms of high density lipoprotein cholesterol (HDL C)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL-C, Not on Apheresis (mg/dL)</measure>
    <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
    <description>Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL-C, Not on Apheresis (mmol/L)</measure>
    <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
    <description>Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL-C From End of Placebo (mg/dL)</measure>
    <time_frame>Samples taken at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18) and Day 168 (week 24)</time_frame>
    <description>Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL-C From End of Placebo (mmol/L)</measure>
    <time_frame>Samples taken at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18) and Day 168 (week 24)</time_frame>
    <description>Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough Concentrations</measure>
    <time_frame>Samples taken 24 hours post-dose at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18)</time_frame>
    <description>Pharmacokinetic profile in terms of trough concentrations. Cross-over phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the cross-over phase. Maintenance phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the maintenance phase.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)</time_frame>
    <description>Safety and tolerability will be described in terms of frequency and severity of adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AE's Leading to Discontinuation</measure>
    <time_frame>From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)</time_frame>
    <description>Safety and tolerability will be described in terms of rate of discontinuations due to adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abnormal Serum Levels</measure>
    <time_frame>From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)</time_frame>
    <description>Safety and tolerability will be described in terms of abnormal serum laboratory values. The reported parameters are not the only ones measured, but rather those for which abnormailities were found</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>Week 0 (start of cross-over), weeks 6, week 12 and week 18</time_frame>
    <description>Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height Z-score</measure>
    <time_frame>Week 0 (start of cross-over), weeks 6, week 12 and week 18</time_frame>
    <description>Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>Week 0 (start of cross-over), weeks 6, week 12 and week 18</time_frame>
    <description>Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tanner Stage</measure>
    <time_frame>Week 0 (start of cross-over)</time_frame>
    <description>Stages for fem (Pubic hair, Breasts):&#xD;
(Preadol,Preadol)&#xD;
(Sparse, lightly pigmented, medial border of labia,Breast and papilla elevated as small mound; areolar diam incr)&#xD;
(Darker, beginning to curl, incr amount, Breast and areola enlarged, no contour separation)&#xD;
(Course, curly, abundant but less amount in adult,Areola and papilla form secondary mound)&#xD;
(Adult fem triangle, spread to medial surface of thighs,Mature, nipple projects, areola part of general breast contour) For males (Pubic hair, Penis, Testes)&#xD;
1=(None,Preadol,Preadol) 2=(Scanty, long, light pigm,Slight enl,Enl scrotum, pink texture alt) 3=(Darker, starts to curl, small amount,Longer,Larger) 4=(Resembles adult type, but less in quant; course, curly,Larger; glans and breadth increased in size,Larger, scrotum dark) 5=(Adult distr, spread to medial thighs,Adult size,Adult size). Progr at a normal rate is preferred. Regr is not preferred.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TG (mg/dL)</measure>
    <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
    <description>Efficacy in terms of triglycerides (TG)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TG (mmol/L)</measure>
    <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
    <description>Efficacy in terms of triglycerides (TG)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL C/HDL C</measure>
    <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
    <description>Efficacy in terms of low density lipoprotein cholesterol (LDL C) / high density lipoprotein cholesterol (HDL C)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TC/HDL C</measure>
    <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
    <description>Efficacy in terms of total cholesterol (TC) / high density lipoprotein cholesterol (HDL C)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-HDL C/HDL C</measure>
    <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
    <description>Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C) / HDL C</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ApoB/ApoA</measure>
    <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
    <description>Efficacy in terms of apolipoprotein B (ApoB) / apolipoprotein A (ApoA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinalysis Abnormalitites</measure>
    <time_frame>Week 0, week 6, week 12 and week 18</time_frame>
    <description>Safety and tolerability will be described in terms of abnormal urine laboratory values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ECG Abnormalities</measure>
    <time_frame>Week 0</time_frame>
    <description>Safety and tolerability will be described in terms of abnormal electro cardio gram (ECG)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Exam Abnormalitites</measure>
    <time_frame>Screening, Week 0, week 6, week 12 and week 18, week 24</time_frame>
    <description>Safety and tolerability will be described in terms of abnormal physical examinations. Only parameters for which abnormalities were found are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abnormal Vital Signs</measure>
    <time_frame>From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)</time_frame>
    <description>Safety and tolerability will be described in terms of abnormal vital signs</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Homozygous Familial Hypercholesterolemia (HoFH)</condition>
  <arm_group>
    <arm_group_label>Rosuvastatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>6-week treatment period, and after crossover finished a 12-week efficacy maintenance phase for all patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>6 weeks treatment during crossover</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin 20mg</intervention_name>
    <description>Active drug will be taken taken orally, QD, either in the morning or in the evening</description>
    <arm_group_label>Rosuvastatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Will be taken taken orally, QD, either in the morning or in the evening</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Prior to any study related procedures being performed, provision of written informed&#xD;
             consent from a parent/both parents or guardian and statement of assent from the child&#xD;
             or adolescent (if required by Institutional Review Board [IRB] or Independent Ethics&#xD;
             Committee [EC] according to local regulations and guidelines). Communication between&#xD;
             the Investigator, patient/guardian and child/adolescent to confirm understanding and&#xD;
             required compliance with the requirements of the study.&#xD;
&#xD;
          2. Male and female children and adolescents (aged 6 to &lt;18 years) with at least 1 of the&#xD;
             following criteria:&#xD;
&#xD;
             Documentation of genetic testing confirming 2 mutated alleles of the LDL receptor gene&#xD;
             locus; and/or&#xD;
&#xD;
             Documented untreated LDL C &gt;500 mg/dL (12.9 mmol/L) and triglyceride (TG) &lt;300 mg/dL&#xD;
             (3.4 mmol/L) and at least 1 of the following criteria:&#xD;
&#xD;
               1. Tendinous and/or cutaneous xanthoma prior to 10 years of age; or&#xD;
&#xD;
               2. Documentation of HoFH in both parents by:&#xD;
&#xD;
                    -  genetic and/or&#xD;
&#xD;
                    -  clinical criteria&#xD;
&#xD;
          3. Negative pregnancy test (b human chorionic gonadotropin analysis) prior to baseline in&#xD;
             females of child bearing potential:&#xD;
&#xD;
               -  Female patients of child bearing potential must adhere to a pregnancy prevention&#xD;
                  method (abstinence, chemical, or mechanical) during the study and 3 months&#xD;
                  following the last dose.&#xD;
&#xD;
               -  Male patients should refrain from fathering a child (including sperm donation)&#xD;
                  during the study and up to 3 months following the last dose; and&#xD;
&#xD;
          4. Willing to follow all study procedures including adherence to dietary guidelines,&#xD;
             study visits, fasting blood draws, and compliance with study treatment regimens.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. History of statin inducted myopathy or serious hypersensitivity reaction to other HMG&#xD;
             CoA reductase inhibitors (statins), including rosuvastatin, at Visit 1.&#xD;
&#xD;
          2. Fasting serum glucose of &gt;9.99 mmol/L (180 mg/dL) or glycosylated hemoglobin &gt;9% at&#xD;
             Visit 1 or patients with a history of diabetic ketoacidosis within the past year.&#xD;
&#xD;
          3. Uncontrolled hypothyroidism defined as thyroid stimulating hormone (TSH) &gt;1.5 times&#xD;
             the upper limit of normal (ULN) at Visit 1 or patients whose thyroid replacement&#xD;
             therapy was initiated or modified within the last 3 months prior to Visit 2.&#xD;
&#xD;
          4. Current active liver disease or hepatic dysfunction (except a confirmed diagnosis of&#xD;
             Gilbert's disease) as defined as elevations of 1.5 times the upper limit of normal&#xD;
             (ULN) for any age in any of the following liver function tests at Visit 1: Alanine&#xD;
             Aminotransferase (ALT), Aspartate Aminotransferase (AST), or bilirubin.&#xD;
&#xD;
          5. Definite or suspected personal history or family history of clinically significant&#xD;
             adverse drug reactions (ADRs), or hypersensitivity to drugs with a similar chemical&#xD;
             structure to rosuvastatin as well as other statins.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brussels (Woluwé-St-Lambert)</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chicoutimi</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>København Ø</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kuala Lumpur</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kubang Kerian</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Goteborg</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>Israel</country>
    <country>Malaysia</country>
    <country>Netherlands</country>
    <country>Taiwan</country>
  </location_countries>
  <removed_countries>
    <country>Germany</country>
    <country>Lebanon</country>
    <country>Sweden</country>
    <country>United States</country>
  </removed_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <results_first_submitted>December 18, 2015</results_first_submitted>
  <results_first_submitted_qc>July 1, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 4, 2016</results_first_posted>
  <last_update_submitted>July 1, 2016</last_update_submitted>
  <last_update_submitted_qc>July 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>LDL-C</keyword>
  <keyword>HoFH</keyword>
  <keyword>Hyperlipidemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperlipoproteinemia Type II</mesh_term>
    <mesh_term>Homozygous Familial Hypercholesterolemia</mesh_term>
    <mesh_term>Hypercholesterolemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rosuvastatin Calcium</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Twenty HoFH patients were recruited to 9 centers within 8 countries (Belgium, Canada, Denmark, Israel, Malaysia, Sweden, Taiwan, and The Netherlands) that participated in the study. FSI date: 03-Nov-2014</recruitment_details>
      <pre_assignment_details>20 enrolled, 3 withdrew consent, 3 did not fulfil eligibility criteria. Among the 14 left, ten went through 4 week lead-in phase and 4 did not.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Overall</title>
          <description>Relevant for the lead-in and maintenance phases</description>
        </group>
        <group group_id="P2">
          <title>Rosuva First Then Placebo</title>
          <description>Relevant for the cross-over phase</description>
        </group>
        <group group_id="P3">
          <title>Placebo First Then Rosuva</title>
          <description>Relevant for the cross-over phase</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Lead-in Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Cross-Over: First Intervention (6 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>No possibility to draw blood</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Cross-Over: Second Interv. (6 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Maintenance Phase (12 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Number of baseline participants are not the same as started as there was a lead-in phase in between and as 6 of the 20 patients starting did not enter the cross-over phase, the beginning of which defines the baseline.</population>
      <group_list>
        <group group_id="B1">
          <title>Cross-over</title>
          <description>Cross-over phase</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
          </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="10.9" spread="2.70"/>
                  </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="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>LDL-Cholesterol (mg/dL)</title>
        <description>Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment</description>
        <time_frame>Samples taken on Day 42 (week 6) and on day 84 (week 12)</time_frame>
        <population>6-17 years HoFH</population>
        <group_list>
          <group group_id="O1">
            <title>C-FAS Rosuvastatin</title>
            <description>Cross-over Full Analysys Set, 6 weeks of Rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>C-FAS Placebo</title>
            <description>Cross-over Full Analysis Set, 6 weeks of Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>LDL-Cholesterol (mg/dL)</title>
          <description>Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment</description>
          <population>6-17 years HoFH</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="396.0" spread="195.99"/>
                    <measurement group_id="O2" value="481.4" spread="184.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>cross-over, null hypothesis is no difference between ros and plc. Powered for 90% detection of 15% delta</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.005</p_value>
            <p_value_desc>statistical significance set at 0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Relative difference in geometric LSM</param_type>
            <param_value>-22.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.5</ci_lower_limit>
            <ci_upper_limit>-9.1</ci_upper_limit>
            <estimate_desc>Rosuvastatin treatment gives on average a 22.3% lower geometric LS mean than placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>LDL-Cholesterol (mmol/L)</title>
        <description>Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment</description>
        <time_frame>Samples taken on Day 42 (week 6) and on day 84 (week 12)</time_frame>
        <population>6-17 years HoFH</population>
        <group_list>
          <group group_id="O1">
            <title>C-FAS Rosuvastatin</title>
            <description>Cross-over Full Analysys Set, 6 weeks of Rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>C-FAS Placebo</title>
            <description>Cross-over Full Analysis Set, 6 weeks of Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>LDL-Cholesterol (mmol/L)</title>
          <description>Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment</description>
          <population>6-17 years HoFH</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.26" spread="5.076"/>
                    <measurement group_id="O2" value="12.47" spread="4.790"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>cross-over, null hypothesis is no difference between ros and plc. Powered for 90% detection of 15% delta</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.005</p_value>
            <p_value_desc>statistical significance set at 0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Relative difference in geometric LSM</param_type>
            <param_value>-22.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.5</ci_lower_limit>
            <ci_upper_limit>-9.1</ci_upper_limit>
            <estimate_desc>Rosuvastatin treatment gives on average a 22.3% lower geometric LS mean than placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>TC (mg/dL)</title>
        <description>Efficacy in terms of total cholesterol (TC)</description>
        <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>C-FAS Rosuvastatin</title>
            <description>Cross-over Full Analysys Set, 6 weeks of Rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>C-FAS Placebo</title>
            <description>Cross-over Full Analysis Set, 6 weeks of Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>TC (mg/dL)</title>
          <description>Efficacy in terms of total cholesterol (TC)</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="447.6" spread="195.46"/>
                    <measurement group_id="O2" value="539.0" spread="184.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>cross-over, null hypothesis is no difference between ros and plc.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.003</p_value>
            <p_value_desc>statistical significance set at 0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Relative difference in geometric LSM</param_type>
            <param_value>-20.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-29.7</ci_lower_limit>
            <ci_upper_limit>-9.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>TC (mmol/L)</title>
        <description>Efficacy in terms of total cholesterol (TC)</description>
        <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>C-FAS Rosuvastatin</title>
            <description>Cross-over Full Analysys Set, 6 weeks of Rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>C-FAS Placebo</title>
            <description>Cross-over Full Analysis Set, 6 weeks of Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>TC (mmol/L)</title>
          <description>Efficacy in terms of total cholesterol (TC)</description>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.59" spread="5.063"/>
                    <measurement group_id="O2" value="13.96" spread="4.790"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>cross-over, null hypothesis is no difference between ros and plc.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.003</p_value>
            <p_value_desc>statistical significance set at 0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Relative difference in geometric LSM</param_type>
            <param_value>-20.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-29.7</ci_lower_limit>
            <ci_upper_limit>-9.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Non-HDL C (mg/dL)</title>
        <description>Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C)</description>
        <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>C-FAS Rosuvastatin</title>
            <description>Cross-over Full Analysys Set, 6 weeks of Rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>C-FAS Placebo</title>
            <description>Cross-over Full Analysis Set, 6 weeks of Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Non-HDL C (mg/dL)</title>
          <description>Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C)</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="412.1" spread="198.62"/>
                    <measurement group_id="O2" value="505.3" spread="186.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>cross-over, null hypothesis is no difference between ros and plc.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.003</p_value>
            <p_value_desc>statistical significance set at 0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Relative difference in geometric LSM</param_type>
            <param_value>-22.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.7</ci_lower_limit>
            <ci_upper_limit>-10.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Non-HDL C (mmol/L)</title>
        <description>Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C)</description>
        <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>C-FAS Rosuvastatin</title>
            <description>Cross-over Full Analysys Set, 6 weeks of Rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>C-FAS Placebo</title>
            <description>Cross-over Full Analysis Set, 6 weeks of Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Non-HDL C (mmol/L)</title>
          <description>Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C)</description>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.67" spread="5.144"/>
                    <measurement group_id="O2" value="13.09" spread="4.826"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>cross-over, null hypothesis is no difference between ros and plc.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.003</p_value>
            <p_value_desc>statistical significance set at 0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Relative difference in geometric LSM</param_type>
            <param_value>-22.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.7</ci_lower_limit>
            <ci_upper_limit>-10.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ApoB (mg/dL)</title>
        <description>Efficacy in terms of apolipoprotein B (ApoB)</description>
        <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>C-FAS Rosuvastatin</title>
            <description>Cross-over Full Analysys Set, 6 weeks of Rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>C-FAS Placebo</title>
            <description>Cross-over Full Analysis Set, 6 weeks of Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>ApoB (mg/dL)</title>
          <description>Efficacy in terms of apolipoprotein B (ApoB)</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="234.9" spread="107.02"/>
                    <measurement group_id="O2" value="267.9" spread="86.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>cross-over, null hypothesis is no difference between ros and plc.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.024</p_value>
            <p_value_desc>statistical significance set at 0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Relative difference in geometric LSM</param_type>
            <param_value>-17.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-29.2</ci_lower_limit>
            <ci_upper_limit>-2.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ApoB (g/L)</title>
        <description>Efficacy in terms of apolipoprotein B (ApoB)</description>
        <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>C-FAS Rosuvastatin</title>
            <description>Cross-over Full Analysys Set, 6 weeks of Rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>C-FAS Placebo</title>
            <description>Cross-over Full Analysis Set, 6 weeks of Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>ApoB (g/L)</title>
          <description>Efficacy in terms of apolipoprotein B (ApoB)</description>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.35" spread="1.070"/>
                    <measurement group_id="O2" value="2.68" spread="0.863"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>cross-over, null hypothesis is no difference between ros and plc.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.024</p_value>
            <p_value_desc>statistical significance set at 0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Relative difference in geometric LSM</param_type>
            <param_value>-17.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-29.2</ci_lower_limit>
            <ci_upper_limit>-2.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HDL-C (mg/dL)</title>
        <description>Efficacy in terms of high density lipoprotein cholesterol (HDL C)</description>
        <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>C-FAS Rosuvastatin</title>
            <description>Cross-over Full Analysys Set, 6 weeks of Rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>C-FAS Placebo</title>
            <description>Cross-over Full Analysis Set, 6 weeks of Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>HDL-C (mg/dL)</title>
          <description>Efficacy in terms of high density lipoprotein cholesterol (HDL C)</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.5" spread="7.29"/>
                    <measurement group_id="O2" value="33.7" spread="8.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>cross-over, null hypothesis is no difference between ros and plc.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.314</p_value>
            <p_value_desc>statistical significance set at 0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Relative difference in geometric LSM</param_type>
            <param_value>7.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.4</ci_lower_limit>
            <ci_upper_limit>24.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HDL-C (mmol/L)</title>
        <description>Efficacy in terms of high density lipoprotein cholesterol (HDL C)</description>
        <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>C-FAS Rosuvastatin</title>
            <description>Cross-over Full Analysys Set, 6 weeks of Rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>C-FAS Placebo</title>
            <description>Cross-over Full Analysis Set, 6 weeks of Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>HDL-C (mmol/L)</title>
          <description>Efficacy in terms of high density lipoprotein cholesterol (HDL C)</description>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.92" spread="0.189"/>
                    <measurement group_id="O2" value="0.87" spread="0.218"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>cross-over, null hypothesis is no difference between ros and plc.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.314</p_value>
            <p_value_desc>statistical significance set at 0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Relative difference in geometric LSM</param_type>
            <param_value>7.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.4</ci_lower_limit>
            <ci_upper_limit>24.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LDL-C, Not on Apheresis (mg/dL)</title>
        <description>Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis</description>
        <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
        <population>Patients not treated with apheresis</population>
        <group_list>
          <group group_id="O1">
            <title>C-FAS Rosuvastatin</title>
            <description>Cross-over Full Analysys Set, 6 weeks of Rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>C-FAS Placebo</title>
            <description>Cross-over Full Analysis Set, 6 weeks of Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>LDL-C, Not on Apheresis (mg/dL)</title>
          <description>Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis</description>
          <population>Patients not treated with apheresis</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="479.8" spread="239.07"/>
                    <measurement group_id="O2" value="594.7" spread="203.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>cross-over, null hypothesis is no difference between ros and plc.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.080</p_value>
            <p_value_desc>statistical significance set at 0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Relative difference in geometric LSM</param_type>
            <param_value>-26.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-48.7</ci_lower_limit>
            <ci_upper_limit>6.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LDL-C, Not on Apheresis (mmol/L)</title>
        <description>Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis</description>
        <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
        <population>Patients not treated with apheresis</population>
        <group_list>
          <group group_id="O1">
            <title>C-FAS Rosuvastatin</title>
            <description>Cross-over Full Analysys Set, 6 weeks of Rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>C-FAS Placebo Not on Apheresis</title>
            <description>Cross-over Full Analysis Set, 6 weeks of Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>LDL-C, Not on Apheresis (mmol/L)</title>
          <description>Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis</description>
          <population>Patients not treated with apheresis</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.43" spread="6.191"/>
                    <measurement group_id="O2" value="15.40" spread="5.274"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>cross-over, null hypothesis is no difference between ros and plc.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.080</p_value>
            <p_value_desc>statistical significance set at 0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Relative difference in geometric LSM</param_type>
            <param_value>-26.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-48.7</ci_lower_limit>
            <ci_upper_limit>6.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LDL-C From End of Placebo (mg/dL)</title>
        <description>Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg</description>
        <time_frame>Samples taken at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18) and Day 168 (week 24)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>M-FAS Rosuvastatin</title>
            <description>Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>M-FAS Placebo</title>
            <description>Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>LDL-C From End of Placebo (mg/dL)</title>
          <description>Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>End of Placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="472.9" spread="171.77"/>
                    <measurement group_id="O2" value="491.3" spread="215.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 weeks after end of Placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="399.4" spread="214.28"/>
                    <measurement group_id="O2" value="421.7" spread="224.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks after end of Placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="345.8" spread="214.69"/>
                    <measurement group_id="O2" value="394.7" spread="178.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 weeks after end of Placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No measurements available since taken only at 6 and 12 weeks after end of placebo</measurement>
                    <measurement group_id="O2" value="441.8" spread="260.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LDL-C From End of Placebo (mmol/L)</title>
        <description>Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg</description>
        <time_frame>Samples taken at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18) and Day 168 (week 24)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>M-FAS Rosuvastatin</title>
            <description>Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>M-FAS Placebo</title>
            <description>Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>LDL-C From End of Placebo (mmol/L)</title>
          <description>Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg</description>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>End of Placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.25" spread="4.449"/>
                    <measurement group_id="O2" value="12.73" spread="5.583"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 weeks after end of Placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.34" spread="5.551"/>
                    <measurement group_id="O2" value="10.92" spread="5.813"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks after end of Placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.96" spread="5.558"/>
                    <measurement group_id="O2" value="10.22" spread="4.621"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 weeks after end of Placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No measurements available since taken only at 6 and 12 weeks after end of placebo</measurement>
                    <measurement group_id="O2" value="11.44" spread="6.740"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Trough Concentrations</title>
        <description>Pharmacokinetic profile in terms of trough concentrations. Cross-over phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the cross-over phase. Maintenance phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the maintenance phase.</description>
        <time_frame>Samples taken 24 hours post-dose at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cross-over Phase</title>
            <description>Measurements taken after 6 weeks active treatment (rosuvastatin) in the cross-over phase</description>
          </group>
          <group group_id="O2">
            <title>Maintenance Phase</title>
            <description>Measurement taken after 6 weeks active treatment (rosuvastatin) in the maintenance phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Trough Concentrations</title>
          <description>Pharmacokinetic profile in terms of trough concentrations. Cross-over phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the cross-over phase. Maintenance phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the maintenance phase.</description>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.387" spread="8.11"/>
                    <measurement group_id="O2" value="4.482" spread="3.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Events</title>
        <description>Safety and tolerability will be described in terms of frequency and severity of adverse events</description>
        <time_frame>From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lead-in</title>
            <description>Optional 10mg lead-in phase, Safety analysis set</description>
          </group>
          <group group_id="O2">
            <title>Cross-over Phase</title>
            <description>Cross-over phase, Safety analysis set</description>
          </group>
          <group group_id="O3">
            <title>Maintenance</title>
            <description>Maintenance Phase, Safety analysis set</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events</title>
          <description>Safety and tolerability will be described in terms of frequency and severity of adverse events</description>
          <units>adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any AE leading to death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AE's Leading to Discontinuation</title>
        <description>Safety and tolerability will be described in terms of rate of discontinuations due to adverse events</description>
        <time_frame>From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lead-in</title>
            <description>Optional 10mg lead-in phase, Safety analysis set</description>
          </group>
          <group group_id="O2">
            <title>Cross-over Phase</title>
            <description>Cross-over phase, Safety analysis set</description>
          </group>
          <group group_id="O3">
            <title>Maintenance Phase</title>
            <description>Maintenance phase, Safety analysis set</description>
          </group>
        </group_list>
        <measure>
          <title>AE's Leading to Discontinuation</title>
          <description>Safety and tolerability will be described in terms of rate of discontinuations due to adverse events</description>
          <units>adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Abnormal Serum Levels</title>
        <description>Safety and tolerability will be described in terms of abnormal serum laboratory values. The reported parameters are not the only ones measured, but rather those for which abnormailities were found</description>
        <time_frame>From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ros/Pla &lt;LLN</title>
            <description>Safety Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>Ros/Pla &gt;ULN</title>
            <description>Safety Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin</description>
          </group>
          <group group_id="O3">
            <title>Pla/Ros &lt;LLN</title>
            <description>Safety Analysis Set, starting cross-over phase with 6 weeks of placebo</description>
          </group>
          <group group_id="O4">
            <title>Pla/Ros &gt;ULN</title>
            <description>Safety Analysis Set, starting cross-over phase with 6 weeks of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Abnormal Serum Levels</title>
          <description>Safety and tolerability will be described in terms of abnormal serum laboratory values. The reported parameters are not the only ones measured, but rather those for which abnormailities were found</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Alanine Aminotransferase week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine Aminotransferase week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine Aminotransferase week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine Aminotransferase week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine Aminotransferase week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bicarbonate week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bicarbonate week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bicarbonate week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bicarbonate week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bicarbonate week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood Urea Nitrogen week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood Urea Nitrogen week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood Urea Nitrogen week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood Urea Nitrogen week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood Urea Nitrogen week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine Kinase week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine Kinase week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine Kinase week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine Kinase week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine Kinase week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Bilirubin week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Bilirubin week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Bilirubin week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Bilirubin week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Bilirubin week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urate week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urate week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urate week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urate week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urate week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular HGB Concentration week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular HGB Concentration week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular HGB Concentration week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular HGB Concentration week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular HGB Concentration week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular Hemoglobin week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular Hemoglobin week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular Hemoglobin week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular Hemoglobin week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular Hemoglobin week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular Volume week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular Volume week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular Volume week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular Volume week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular Volume week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes/Leukocytes week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes/Leukocytes week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes/Leukocytes week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes/Leukocytes week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes/Leukocytes week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils, Segmented/Leukocytes week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils, Segmented/Leukocytes week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils, Segmented/Leukocytes week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils, Segmented/Leukocytes week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils, Segmented/Leukocytes week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils/Leukocytes week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils/Leukocytes week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils/Leukocytes week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils/Leukocytes week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils/Leukocytes week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Height</title>
        <description>Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.</description>
        <time_frame>Week 0 (start of cross-over), weeks 6, week 12 and week 18</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ros/Pla</title>
            <description>Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>Pla/Ros</title>
            <description>Safety Analysis Set, starting crossover-phase with 6 weeks of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Height</title>
          <description>Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.</description>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Height (cm) week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144.0" spread="17.82"/>
                    <measurement group_id="O2" value="140.9" spread="15.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Height (cm) week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144.9" spread="17.70"/>
                    <measurement group_id="O2" value="141.1" spread="16.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Height (cm) week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145.7" spread="18.07"/>
                    <measurement group_id="O2" value="142.0" spread="17.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Height (cm) week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146.9" spread="17.68"/>
                    <measurement group_id="O2" value="142.3" spread="16.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Height (cm) week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="147.1" spread="17.94"/>
                    <measurement group_id="O2" value="143.5" spread="17.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Height Z-score</title>
        <description>Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.</description>
        <time_frame>Week 0 (start of cross-over), weeks 6, week 12 and week 18</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ros/Pla</title>
            <description>Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>Pla/Ros</title>
            <description>Safety Analysis Set, starting crossover-phase with 6 weeks of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Height Z-score</title>
          <description>Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Height z-score week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.42" spread="1.697"/>
                    <measurement group_id="O2" value="-0.75" spread="1.555"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Height z-score week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.29" spread="1.703"/>
                    <measurement group_id="O2" value="-0.71" spread="1.644"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Height z-score week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.18" spread="1.742"/>
                    <measurement group_id="O2" value="-0.70" spread="1.776"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Height z-score week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="1.721"/>
                    <measurement group_id="O2" value="-0.65" spread="1.757"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Height z-score week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="1.752"/>
                    <measurement group_id="O2" value="-0.49" spread="1.758"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weight</title>
        <description>Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.</description>
        <time_frame>Week 0 (start of cross-over), weeks 6, week 12 and week 18</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ros/Pla</title>
            <description>Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>Pla/Ros</title>
            <description>Safety Analysis Set, starting crossover-phase with 6 weeks of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Weight</title>
          <description>Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Weight (kg) week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.39" spread="12.731"/>
                    <measurement group_id="O2" value="40.19" spread="16.520"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight (kg) week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.14" spread="13.577"/>
                    <measurement group_id="O2" value="40.36" spread="16.462"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight (kg) week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.63" spread="14.426"/>
                    <measurement group_id="O2" value="42.30" spread="18.651"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight (kg) week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.31" spread="14.588"/>
                    <measurement group_id="O2" value="42.50" spread="17.990"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight (kg) week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.90" spread="14.550"/>
                    <measurement group_id="O2" value="43.00" spread="17.867"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tanner Stage</title>
        <description>Stages for fem (Pubic hair, Breasts):&#xD;
(Preadol,Preadol)&#xD;
(Sparse, lightly pigmented, medial border of labia,Breast and papilla elevated as small mound; areolar diam incr)&#xD;
(Darker, beginning to curl, incr amount, Breast and areola enlarged, no contour separation)&#xD;
(Course, curly, abundant but less amount in adult,Areola and papilla form secondary mound)&#xD;
(Adult fem triangle, spread to medial surface of thighs,Mature, nipple projects, areola part of general breast contour) For males (Pubic hair, Penis, Testes)&#xD;
1=(None,Preadol,Preadol) 2=(Scanty, long, light pigm,Slight enl,Enl scrotum, pink texture alt) 3=(Darker, starts to curl, small amount,Longer,Larger) 4=(Resembles adult type, but less in quant; course, curly,Larger; glans and breadth increased in size,Larger, scrotum dark) 5=(Adult distr, spread to medial thighs,Adult size,Adult size). Progr at a normal rate is preferred. Regr is not preferred.</description>
        <time_frame>Week 0 (start of cross-over)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ros/Pla</title>
            <description>Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>Pla/Ros</title>
            <description>Safety Analysis Set, starting crossover-phase with 6 weeks of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Tanner Stage</title>
          <description>Stages for fem (Pubic hair, Breasts):&#xD;
(Preadol,Preadol)&#xD;
(Sparse, lightly pigmented, medial border of labia,Breast and papilla elevated as small mound; areolar diam incr)&#xD;
(Darker, beginning to curl, incr amount, Breast and areola enlarged, no contour separation)&#xD;
(Course, curly, abundant but less amount in adult,Areola and papilla form secondary mound)&#xD;
(Adult fem triangle, spread to medial surface of thighs,Mature, nipple projects, areola part of general breast contour) For males (Pubic hair, Penis, Testes)&#xD;
1=(None,Preadol,Preadol) 2=(Scanty, long, light pigm,Slight enl,Enl scrotum, pink texture alt) 3=(Darker, starts to curl, small amount,Longer,Larger) 4=(Resembles adult type, but less in quant; course, curly,Larger; glans and breadth increased in size,Larger, scrotum dark) 5=(Adult distr, spread to medial thighs,Adult size,Adult size). Progr at a normal rate is preferred. Regr is not preferred.</description>
          <units>stage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Tanner stage week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="1.41"/>
                    <measurement group_id="O2" value="1.7" spread="1.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tanner stage week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="1.38"/>
                    <measurement group_id="O2" value="2.0" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>TG (mg/dL)</title>
        <description>Efficacy in terms of triglycerides (TG)</description>
        <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>C-FAS Rosuvastatin</title>
            <description>Cross-over Full Analysys Set, 6 weeks of Rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>C-FAS Placebo</title>
            <description>Cross-over Full Analysis Set, 6 weeks of Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>TG (mg/dL)</title>
          <description>Efficacy in terms of triglycerides (TG)</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.8" spread="24.48"/>
                    <measurement group_id="O2" value="119.5" spread="52.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>cross-over, null hypothesis is no difference between ros and plc.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.004</p_value>
            <p_value_desc>statistical significance set at 0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Relative difference in geometric LSM</param_type>
            <param_value>-30.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-44.2</ci_lower_limit>
            <ci_upper_limit>-13.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>TG (mmol/L)</title>
        <description>Efficacy in terms of triglycerides (TG)</description>
        <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>C-FAS Rosuvastatin</title>
            <description>Cross-over Full Analysys Set, 6 weeks of Rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>C-FAS Placebo</title>
            <description>Cross-over Full Analysis Set, 6 weeks of Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>TG (mmol/L)</title>
          <description>Efficacy in terms of triglycerides (TG)</description>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.90" spread="0.277"/>
                    <measurement group_id="O2" value="1.35" spread="0.595"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>cross-over, null hypothesis is no difference between ros and plc.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.004</p_value>
            <p_value_desc>statistical significance set at 0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Relative difference in geometric LSM</param_type>
            <param_value>-30.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-44.2</ci_lower_limit>
            <ci_upper_limit>-13.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>LDL C/HDL C</title>
        <description>Efficacy in terms of low density lipoprotein cholesterol (LDL C) / high density lipoprotein cholesterol (HDL C)</description>
        <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>C-FAS Rosuvastatin</title>
            <description>Cross-over Full Analysys Set, 6 weeks of Rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>C-FAS Placebo</title>
            <description>Cross-over Full Analysis Set, 6 weeks of Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>LDL C/HDL C</title>
          <description>Efficacy in terms of low density lipoprotein cholesterol (LDL C) / high density lipoprotein cholesterol (HDL C)</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.208" spread="7.8638"/>
                    <measurement group_id="O2" value="15.600" spread="9.1317"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>cross-over, null hypothesis is no difference between ros and plc.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.006</p_value>
            <p_value_desc>statistical significance set at 0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Relative difference in geometric LSM</param_type>
            <param_value>-27.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-41.2</ci_lower_limit>
            <ci_upper_limit>-11.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>TC/HDL C</title>
        <description>Efficacy in terms of total cholesterol (TC) / high density lipoprotein cholesterol (HDL C)</description>
        <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>C-FAS Rosuvastatin</title>
            <description>Cross-over Full Analysys Set, 6 weeks of Rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>C-FAS Placebo</title>
            <description>Cross-over Full Analysis Set, 6 weeks of Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>TC/HDL C</title>
          <description>Efficacy in terms of total cholesterol (TC) / high density lipoprotein cholesterol (HDL C)</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.704" spread="8.0414"/>
                    <measurement group_id="O2" value="17.416" spread="9.5454"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>cross-over, null hypothesis is no difference between ros and plc.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.005</p_value>
            <p_value_desc>statistical significance set at 0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Relative difference in geometric LSM</param_type>
            <param_value>-25.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-38.1</ci_lower_limit>
            <ci_upper_limit>-10.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Non-HDL C/HDL C</title>
        <description>Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C) / HDL C</description>
        <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>C-FAS Rosuvastatin</title>
            <description>Cross-over Full Analysys Set, 6 weeks of Rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>C-FAS Placebo</title>
            <description>Cross-over Full Analysis Set, 6 weeks of Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Non-HDL C/HDL C</title>
          <description>Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C) / HDL C</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.704" spread="8.0414"/>
                    <measurement group_id="O2" value="16.416" spread="9.5454"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>cross-over, null hypothesis is no difference between ros and plc.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.005</p_value>
            <p_value_desc>statistical significance set at 0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Relative difference in geometric LSM</param_type>
            <param_value>-28.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-41.7</ci_lower_limit>
            <ci_upper_limit>-11.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ApoB/ApoA</title>
        <description>Efficacy in terms of apolipoprotein B (ApoB) / apolipoprotein A (ApoA)</description>
        <time_frame>Samples taken at Day 42 (week 6) and Day 84 (week 12)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>C-FAS Rosuvastatin</title>
            <description>Cross-over Full Analysys Set, 6 weeks of Rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>C-FAS Placebo</title>
            <description>Cross-over Full Analysis Set, 6 weeks of Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>ApoB/ApoA</title>
          <description>Efficacy in terms of apolipoprotein B (ApoB) / apolipoprotein A (ApoA)</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.408" spread="1.3259"/>
                    <measurement group_id="O2" value="2.873" spread="1.4669"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>cross-over, null hypothesis is no difference between ros and plc.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.013</p_value>
            <p_value_desc>statistical significance set at 0.05</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Relative difference in geometric LSM</param_type>
            <param_value>-20.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-32.8</ci_lower_limit>
            <ci_upper_limit>-5.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Urinalysis Abnormalitites</title>
        <description>Safety and tolerability will be described in terms of abnormal urine laboratory values</description>
        <time_frame>Week 0, week 6, week 12 and week 18</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ros/Pla</title>
            <description>Safety Analysis Set, starting crossover-phase with 6 weeks of rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>Pla/Ros</title>
            <description>Safety Analysis Set, starting crossover-phase with 6 weeks of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Urinalysis Abnormalitites</title>
          <description>Safety and tolerability will be described in terms of abnormal urine laboratory values</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Urine Protein week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Protein week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Protein week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Protein week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Protein week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Ketones week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Ketones week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Ketones week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Ketones week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Ketones week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Blood week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Blood week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Blood week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Blood week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Blood week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ECG Abnormalities</title>
        <description>Safety and tolerability will be described in terms of abnormal electro cardio gram (ECG)</description>
        <time_frame>Week 0</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Safety Analysis Set</title>
            <description>Safety Analysis Set</description>
          </group>
          <group group_id="O2">
            <title>C-FAS Rosuvastatin</title>
            <description>Cross-over Full Analysys Set, 6 weeks of Rosuvastatin</description>
          </group>
          <group group_id="O3">
            <title>C-FAS Placebo</title>
            <description>Cross-over Full Analysis Set, 6 weeks of Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>ECG Abnormalities</title>
          <description>Safety and tolerability will be described in terms of abnormal electro cardio gram (ECG)</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physical Exam Abnormalitites</title>
        <description>Safety and tolerability will be described in terms of abnormal physical examinations. Only parameters for which abnormalities were found are reported.</description>
        <time_frame>Screening, Week 0, week 6, week 12 and week 18, week 24</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ros/Pla</title>
            <description>Safety Analysis Set, starting crossover-phase with 6 weeks of rosuvastatin</description>
          </group>
          <group group_id="O2">
            <title>Pla/Ros</title>
            <description>Safety Analysis Set, starting crossover-phase with 6 weeks of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Physical Exam Abnormalitites</title>
          <description>Safety and tolerability will be described in terms of abnormal physical examinations. Only parameters for which abnormalities were found are reported.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>General Appearance screening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Appearance week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Appearance week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Appearance week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Appearance week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Appearance week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Head and Neck screening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Head and Neck week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Head and Neck week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Head and Neck week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Head and Neck week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Head and Neck week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Nodes screening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Nodes week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Nodes week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Nodes week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Nodes week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Nodes week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin screening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Abnormal Vital Signs</title>
        <description>Safety and tolerability will be described in terms of abnormal vital signs</description>
        <time_frame>From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Safety Analysis Set</title>
            <description>Safety Analysis Set</description>
          </group>
        </group_list>
        <measure>
          <title>Abnormal Vital Signs</title>
          <description>Safety and tolerability will be described in terms of abnormal vital signs</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Lead-in</title>
          <description>Lead-in</description>
        </group>
        <group group_id="E2">
          <title>Cross-over</title>
          <description>Cross-over phase</description>
        </group>
        <group group_id="E3">
          <title>Maintenance</title>
          <description>Maintenance phase</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="4" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood bicarbonate decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="13"/>
              </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>Upon completion of the Clinical Trial (CT), the Principal Investigator (PI) may prepare the data derived from the CT for publication or presentation. Material should be submitted to the Sponsor for review prior to review or submission for publication, or public dissemination. Publications from individual sites must not precede the primary manuscript, but if not published within twelve months after completion of the CT, the PI has the right to publish or present the methods and results of the CT.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Robin Mukherjee</name_or_title>
      <organization>AstraZeneca Plc</organization>
      <phone>+46 31 776 1000</phone>
      <email>robin.mukherjee@astrazeneca.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/NCT02226198
org study id: D3561C00004
nct id: NCT02226198
lead sponsor: 
has dmc: No
The purpose of the study is to establish the efficacy, safety and tolerability of
      rosuvastatin in children and adolescents with homozygous familial hypercholesterolemia.
This is a randomized, double-blind, placebo-controlled, multi-center, cross-over study of the
      efficacy, safety and tolerability rosuvastatin in children and adolescents (aged 6 to <18
      years) with homozygous familial hypercholesterolemia (HoFH). The study is designed to assess
      the efficacy of rosuvastatin 20 mg compared to placebo on lipids, lipoproteins and
      apolipoproteins in pediatric patients with HoFH. The outcome measures to be assessed include
      low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C),
      total cholesterol (TC), triglycerides, non-HDL-C, LDL-C/HDL-C, TC/HDL-C, non-HDL-C/HDL-C,
      apolipoprotein B (ApoB), apolipoprotein A 1 (ApoA-1) and ApoB/ApoA-1 following 6 weeks of
      treatment with rosuvastatin 20 mg or placebo. Pharmacokinetic data of the trough plasma
      exposure of rosuvastatin will also be assessed in these pediatric patients with HoFH.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: LDL-Cholesterol (mg/dL)
time frame: Samples taken on Day 42 (week 6) and on day 84 (week 12)
description: Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment
measure: LDL-Cholesterol (mmol/L)
time frame: Samples taken on Day 42 (week 6) and on day 84 (week 12)
description: Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment
measure: TC (mg/dL)
time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)
description: Efficacy in terms of total cholesterol (TC)
measure: TC (mmol/L)
time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)
description: Efficacy in terms of total cholesterol (TC)
measure: Non-HDL C (mg/dL)
time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)
description: Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C)
measure: Non-HDL C (mmol/L)
time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)
description: Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C)
measure: ApoB (mg/dL)
time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)
description: Efficacy in terms of apolipoprotein B (ApoB)
measure: ApoB (g/L)
time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)
description: Efficacy in terms of apolipoprotein B (ApoB)
measure: HDL-C (mg/dL)
time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)
description: Efficacy in terms of high density lipoprotein cholesterol (HDL C)
measure: HDL-C (mmol/L)
time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)
description: Efficacy in terms of high density lipoprotein cholesterol (HDL C)
measure: LDL-C, Not on Apheresis (mg/dL)
time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)
description: Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis
measure: LDL-C, Not on Apheresis (mmol/L)
time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)
description: Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis
measure: LDL-C From End of Placebo (mg/dL)
time frame: Samples taken at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18) and Day 168 (week 24)
description: Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg
measure: LDL-C From End of Placebo (mmol/L)
time frame: Samples taken at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18) and Day 168 (week 24)
description: Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg
measure: Trough Concentrations
time frame: Samples taken 24 hours post-dose at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18)
description: Pharmacokinetic profile in terms of trough concentrations. Cross-over phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the cross-over phase. Maintenance phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the maintenance phase.
measure: Adverse Events
time frame: From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)
description: Safety and tolerability will be described in terms of frequency and severity of adverse events
measure: AE's Leading to Discontinuation
time frame: From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)
description: Safety and tolerability will be described in terms of rate of discontinuations due to adverse events
measure: Abnormal Serum Levels
time frame: From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)
description: Safety and tolerability will be described in terms of abnormal serum laboratory values. The reported parameters are not the only ones measured, but rather those for which abnormailities were found
measure: Height
time frame: Week 0 (start of cross-over), weeks 6, week 12 and week 18
description: Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.
measure: Height Z-score
time frame: Week 0 (start of cross-over), weeks 6, week 12 and week 18
description: Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.
measure: Weight
time frame: Week 0 (start of cross-over), weeks 6, week 12 and week 18
description: Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.
measure: Tanner Stage
time frame: Week 0 (start of cross-over)
description: Stages for fem (Pubic hair, Breasts):
(Preadol,Preadol)
(Sparse, lightly pigmented, medial border of labia,Breast and papilla elevated as small mound; areolar diam incr)
(Darker, beginning to curl, incr amount, Breast and areola enlarged, no contour separation)
(Course, curly, abundant but less amount in adult,Areola and papilla form secondary mound)
(Adult fem triangle, spread to medial surface of thighs,Mature, nipple projects, areola part of general breast contour) For males (Pubic hair, Penis, Testes)
1=(None,Preadol,Preadol) 2=(Scanty, long, light pigm,Slight enl,Enl scrotum, pink texture alt) 3=(Darker, starts to curl, small amount,Longer,Larger) 4=(Resembles adult type, but less in quant; course, curly,Larger; glans and breadth increased in size,Larger, scrotum dark) 5=(Adult distr, spread to medial thighs,Adult size,Adult size). Progr at a normal rate is preferred. Regr is not preferred.
measure: TG (mg/dL)
time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)
description: Efficacy in terms of triglycerides (TG)
measure: TG (mmol/L)
time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)
description: Efficacy in terms of triglycerides (TG)
measure: LDL C/HDL C
time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)
description: Efficacy in terms of low density lipoprotein cholesterol (LDL C) / high density lipoprotein cholesterol (HDL C)
measure: TC/HDL C
time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)
description: Efficacy in terms of total cholesterol (TC) / high density lipoprotein cholesterol (HDL C)
measure: Non-HDL C/HDL C
time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)
description: Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C) / HDL C
measure: ApoB/ApoA
time frame: Samples taken at Day 42 (week 6) and Day 84 (week 12)
description: Efficacy in terms of apolipoprotein B (ApoB) / apolipoprotein A (ApoA)
measure: Urinalysis Abnormalitites
time frame: Week 0, week 6, week 12 and week 18
description: Safety and tolerability will be described in terms of abnormal urine laboratory values
measure: ECG Abnormalities
time frame: Week 0
description: Safety and tolerability will be described in terms of abnormal electro cardio gram (ECG)
measure: Physical Exam Abnormalitites
time frame: Screening, Week 0, week 6, week 12 and week 18, week 24
description: Safety and tolerability will be described in terms of abnormal physical examinations. Only parameters for which abnormalities were found are reported.
measure: Abnormal Vital Signs
time frame: From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)
description: Safety and tolerability will be described in terms of abnormal vital signs
arm group label: Rosuvastatin
arm group type: Active Comparator
description: 6-week treatment period, and after crossover finished a 12-week efficacy maintenance phase for all patients
arm group label: Placebo
arm group type: Placebo Comparator
description: 6 weeks treatment during crossover
intervention type: Drug
intervention name: Rosuvastatin 20mg
description: Active drug will be taken taken orally, QD, either in the morning or in the evening
arm group label: Rosuvastatin
intervention type: Drug
intervention name: Placebo
description: Will be taken taken orally, QD, either in the morning or in the evening
arm group label: Placebo
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Canada
country: Denmark
country: Israel
country: Malaysia
country: Netherlands
country: Taiwan
country: Germany
country: Lebanon
country: Sweden
country: United States
responsible party type: Sponsor
mesh term: Hyperlipoproteinemia Type II
mesh term: Homozygous Familial Hypercholesterolemia
mesh term: Hypercholesterolemia
mesh term: Rosuvastatin Calcium
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 