<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/NCT03811028</url>
  </required_header>
  <id_info>
    <org_study_id>SOBI003-002</org_study_id>
    <nct_id>NCT03811028</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Safety, Tolerability, and Efficacy of Long-term SOBI003 Treatment in Pediatric MPS IIIA Patients</brief_title>
  <official_title>An Open, Single-arm, Multicenter Extension Study to Assess the Safety, Tolerability, and Efficacy of Long-term SOBI003 Treatment in Pediatric MPS IIIA Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swedish Orphan Biovitrum</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Swedish Orphan Biovitrum</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      MPS IIIA, also known as Sanfilippo A, is an inherited lysosomal storage disease (LSD). MPS&#xD;
      IIIA is caused by a deficiency in sulfamidase, one of the enzymes involved in the lysosomal&#xD;
      degradation of the glycosaminoglycan (GAG) heparan sulfate (HS). The natural course of MPS&#xD;
      IIIA is characterized by devastating neurodegeneration with initially mild somatic&#xD;
      involvement. The aim of the present study is to assess the safety, tolerability and efficacy&#xD;
      of long-term SOBI003 treatment. SOBI003 is a chemically modified recombinant human (rh)&#xD;
      Sulfamidase developed as an enzyme replacement therapy (ERT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open, single-arm, multicenter extension study to assess the safety, tolerability&#xD;
      and efficacy of long-term SOBI003 treatment in pediatric MPS IIIA patients. The study is an&#xD;
      extension of the First in Human (FIH) SOBI003-001 study, allowing continuous treatment of&#xD;
      SOBI003 for up to 2 years. Study patients who complete Week 24 of the FIH study (SOBI003-001)&#xD;
      will be invited to continue to Week 25 in the extension study.&#xD;
&#xD;
      When entering the extension study, these patients will receive the highest dose that has been&#xD;
      declared safe in the ongoing FIH study (SOBI003-001). Upon completion of the FIH study, an&#xD;
      analysis aimed at selecting the dose for forthcoming studies will take place. Once the dose&#xD;
      has been selected, this dose will be applied to all patients enrolled in the extension study.&#xD;
      The total duration of the extension study for an individual patient is 80 weeks, resulting in&#xD;
      a total of 104 weeks (2 years) of SOBI003 treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2019</start_date>
  <completion_date type="Actual">May 7, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety as Measured by Adverse Events Frequencies (by Type and Severity)</measure>
    <time_frame>From infusion week 25 up to week 104</time_frame>
    <description>Number of adverse events, by type and severity, from week 25 up to week 104</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Observed SOBI003 Serum Concentration Immediately Before the Start of Infusion of SOBI003</measure>
    <time_frame>Weeks 38, 52, 78 and 104</time_frame>
    <description>The observed SOBI003 serum concentration immediately before the start of infusion of SOBI003 (CPre-dose) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Observed SOBI003 Serum Concentration at the End of Infusion of SOBI003</measure>
    <time_frame>Weeks 38, 52, 78 and 104</time_frame>
    <description>The observed SOBI003 serum concentration at the end of infusion of SOBI003 (CEnd of inf) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Time of the End of the Infusion of SOBI003</measure>
    <time_frame>Weeks 38, 52, 78 and 104</time_frame>
    <description>The time of the end of infusion of SOBI003 (tEnd of inf) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Maximum Observed Serum Concentration of SOBI003</measure>
    <time_frame>Weeks 38, 52, 78 and 104</time_frame>
    <description>The maximum observed serum concentration of SOBI003 (Cmax) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Time at Which the Maximum Serum Concentration of SOBI003 is Observed</measure>
    <time_frame>Weeks 38, 52, 78 and 104</time_frame>
    <description>The time after start of infusion at which the maximum serum concentration is observed (tmax) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Minimum Observed Serum Concentration of SOBI003</measure>
    <time_frame>Weeks 38, 52, 78 and 104</time_frame>
    <description>The minimum observed serum concentration of SOBI003 (CTrough) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance</measure>
    <time_frame>Weeks 38, 52, 78 and 104</time_frame>
    <description>Clearance (CL) of SOBI003 Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the SOBI003 Serum Concentration-time Curve From Time 0 to168 Hours</measure>
    <time_frame>0,1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post-dose on Weeks 38, 52, 78 and 104</time_frame>
    <description>Area under the SOBI003 serum concentration-time curve from time 0 to 168 hours (AUC 0-168h) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Half-life</measure>
    <time_frame>Weeks 38, 52, 78 and 104</time_frame>
    <description>The half-life of SOBI003 in serum (T1/2) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SOBI003 Concentration in Cerebrospinal Fluid</measure>
    <time_frame>Weeks 52 and 104</time_frame>
    <description>Concentration of SOBI003 in cerebrospinal fluid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Having Anti-drug Antibodies in Serum</measure>
    <time_frame>Weeks 38, 52, 78 and 104</time_frame>
    <description>Number of patients in each dose group having anti-drug antibodies in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Having Anti-drug Antibodies in Cerebrospinal Fluid</measure>
    <time_frame>Weeks 52 and 104</time_frame>
    <description>Number of patients in each dose group having anti-drug antibodies cerebrospinal fluid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Heparan Sulfate Concentration in Cerebrospinal Fluid</measure>
    <time_frame>Weeks 52 and 104</time_frame>
    <description>Change from baseline, in percent, of Heparan Sulfate levels in cerebrospinal fluid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Heparan Sulfate Levels in Serum</measure>
    <time_frame>Weeks 38, 52, 78 and 104</time_frame>
    <description>Change from baseline in Heparan sulfate, in mg/L, levels in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Heparan Sulfate Levels in Urine</measure>
    <time_frame>Weeks 38, 52, 78 and 104</time_frame>
    <description>Change from baseline in Heparan sulfate levels, in g/mol, in urine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Neurocognitive Development Quotient</measure>
    <time_frame>Weeks 52 and 104</time_frame>
    <description>Quotient between age equivalent score and age, 0 - 100%, where high values are desirable. The age equivalent score represent the age of the typical and normal individual who would achieve the same result as the one who was tested The age equivalent scores are assessed by the Bayley Scales of Infant and Toddler Development®, third edition cognitive subtest or the Kaufman Assessment Battery for Children, Second edition.&#xD;
The Bayley Scales of Infant and Toddler Development-Third Edition is an individually administered test designed to assess developmental functioning of infants and toddlers. The Bayley-III assesses development in five areas: cognitive, language, motor,social-emotional, and adaptive behavior.&#xD;
The Kaufman Assessment Battery for Children (K-ABC) is a clinical instrument for assessing cognitive development.&#xD;
These results are truly &quot;unitless&quot;/&quot;dimensionless&quot; because they represents quotients of values from the same scale, which means that the units in the denominator and</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Age-equivalence Score</measure>
    <time_frame>Week 52 and 104</time_frame>
    <description>The age equivalent score represent the age in months of the typical and normal individual who would achieve the same result as the one who was tested. The age equivalent scores are assessed by the Bayley Scales of Infant and Toddler Development®, third edition cognitive subtest or the Kaufman Assessment Battery for Children, Second edition. The Bayley Scales of Infant and Toddler Development-Third Edition is an individually administered test designed to assess developmental functioning of infants and toddlers. The Bayley-III assesses development in five areas: cognitive, language, motor, social-emotional, and adaptive behavior. The Kaufman Assessment Battery for Children (K-ABC) is a clinical instrument for assessing cognitive development.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Age-equivalence Score as Assessed Either by the BSID-III, Cognitive Subtest, or the KABC-II.</measure>
    <time_frame>Week 52 and 104</time_frame>
    <description>The age equivalent score represent the age in months of the typical and normal individual who would achieve the same result as the one who was tested. The age equivalent scores are assessed by Vineland™ Adaptive Behavior Scales, Expanded Interview Form, Second edition (VABS-II). The Vineland is designed to measure adaptive behavior of individuals from birth to age 90. The Vineland-II contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Age-equivalence Score as Assessed Either by the BSID-III, Cognitive Subtest, or the KABC-II.</measure>
    <time_frame>Week 52 and 104</time_frame>
    <description>The age equivalent score represents the age in months of the typical and normal individual who would achieve the same result as the one who was tested.&#xD;
The age equivalent scores are assessed either by the Bayley Scales of Infant and Toddler Development®, third edition, (BSID-III) cognitive subtest or the Kaufman Assessment Battery for Children, Second edition (KABC-II) depending on chronological age of the subject. Quotient between age equivalent score and age, 0 - 100%, where high values are desirable.&#xD;
The BSID-III is an individually administered test designed to assess developmental functioning of infants and toddlers. The BSID-III assesses development in five areas: cognitive, language, motor, social-emotional, and adaptive behavior.&#xD;
The KABC-II is a clinical instrument for assessing cognitive development. The unit and measurement is the same in both scales (BSID-III and KABC-II): Age-equivalent score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Age-equivalence Score as Assessed by VABS-II</measure>
    <time_frame>Week 52 and 104</time_frame>
    <description>The age equivalent score represent the age in months of the typical and normal individual who would achieve the same result as the one who was tested.&#xD;
The age equivalent scores are assessed by Vineland™ Adaptive Behavior Scales, Expanded Interview Form, Second edition (VABS-II). The Vineland is designed to measure adaptive behavior of individuals from birth to age 90.&#xD;
The Vineland-II contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Age-equivalence Score as Assessed by VABS-II</measure>
    <time_frame>Week 52 and 104</time_frame>
    <description>The age equivalent score represent the age in months of the typical and normal individual who would achieve the same result as the one who was tested.&#xD;
The age equivalent scores are assessed by Vineland™ Adaptive Behavior Scales, Expanded Interview Form, Second edition (VABS-II). The Vineland is designed to measure adaptive behavior of individuals from birth to age 90.&#xD;
The Vineland-II contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Gray Matter Volume</measure>
    <time_frame>Week 52 and 104</time_frame>
    <description>Grey matter contains most of the brain's neuronal cell bodies. The grey matter includes regions of the brain involved in muscle control, and sensory perception such as seeing and hearing, memory, emotions, speech, decision making, and self-control. The gray matter volume will be measured by volumetric magnetic resonance imaging (MRI) at weeks 52 and 104.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric Quality of Life Inventory (PedsQL™) Total Score</measure>
    <time_frame>Week 52 and 104</time_frame>
    <description>Pediatric Quality of Life Inventory (PedsQL™) is a modular approach to measuring health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. Lower scores indicate better functioning. Min score = 0, and max score = 144.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pediatric Quality of Life Inventory (PedsQL™) Total Score</measure>
    <time_frame>Week 52 and 104</time_frame>
    <description>Pediatric Quality of Life Inventory (PedsQL™) is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. Higher scores indicate better functioning. Min score = 0, and max score = 144.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PedsQL™ Family Impact Module Total Score</measure>
    <time_frame>Week 52 and 104</time_frame>
    <description>Pediatric Quality of Life Inventory (PedsQL™) is a modular approach to measuring health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. The Total Score is the sum of all 36 items in the test divided by the number of items answered. Higher scores indicate better functioning. Min score = 0, and max score = 144.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in PedsQL™ Family Impact Module Total Score</measure>
    <time_frame>Week 52 and 104</time_frame>
    <description>Pediatric Quality of Life Inventory (PedsQL™) is a modular approach to measuring health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. The Total Score is the sum of all 36 items in the test divided by the number of items answered. Higher scores indicate better functioning.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Sanfilippo Syndrome Type A (MPS IIIA)</condition>
  <arm_group>
    <arm_group_label>SOBI003</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SOBI003 solution, 20 mg/mL, is mixed with NaCl 0.9% infusion solution prior to administration. For a bodyweight &lt; 25 kg, the total infusion volume is 100 mL. For a bodyweight ≥ 25 kg, the total infusion volume is 250 mL.&#xD;
SOBI003 is administered as i.v. infusions given once weekly for a duration of 80 weeks (from Week 25 until Week 104 following the first 24 weeks of SOBI003 administration in the FIH study (SOBI003-001) study. The SOBI003 dose will be adjusted to the highest dose that has been declared safe by the safety review committee on the FIH study.Hence, dose adjustments may occur a couple of times on the extension study until the final decided dose has been determined.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SOBI003</intervention_name>
    <description>weekly i.v. infusion</description>
    <arm_group_label>SOBI003</arm_group_label>
    <other_name>Modified recombinant human sulphamidase</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Completion of study SOBI003-001&#xD;
&#xD;
          -  Informed consent obtained from the patient´s legally authorized representative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If, in the opinion of the investigator, there are patient specific safety concerns&#xD;
             that contraindicates further treatment with SOBI003&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>78 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Harmatz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children´s Hospital and Research Center, Oakland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children´s Hospital and research center</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina hospitals</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gazi University Hospital</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <results_first_submitted>December 7, 2021</results_first_submitted>
  <results_first_submitted_qc>February 2, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 25, 2022</results_first_posted>
  <last_update_submitted>February 2, 2022</last_update_submitted>
  <last_update_submitted_qc>February 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mucopolysaccharidosis III</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 29, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03811028/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03811028/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dose Group 1</title>
          <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
        </group>
        <group group_id="P2">
          <title>Dose Group 2</title>
          <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dose Group 1</title>
          <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
        </group>
        <group group_id="B2">
          <title>Dose Group 2</title>
          <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="6"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.0" spread="23.8"/>
                    <measurement group_id="B2" value="34.7" spread="12.7"/>
                    <measurement group_id="B3" value="43.3" spread="19.5"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Safety as Measured by Adverse Events Frequencies (by Type and Severity)</title>
        <description>Number of adverse events, by type and severity, from week 25 up to week 104</description>
        <time_frame>From infusion week 25 up to week 104</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104 SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Safety as Measured by Adverse Events Frequencies (by Type and Severity)</title>
          <description>Number of adverse events, by type and severity, from week 25 up to week 104</description>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="174"/>
                    <measurement group_id="O2" value="355"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any non-treatment emergent serious adverse event</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>Any treatment emergent adverse event (TEAE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="174"/>
                    <measurement group_id="O2" value="351"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any drug-related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                    <measurement group_id="O2" value="202"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any non-serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="172"/>
                    <measurement group_id="O2" value="342"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any serious drug-related TEAE</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>Any TEAE leading to study and/or treatment withdrawal</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>Any drug-related TEAE leading to study and/or treatment withdrawal</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>Any serious TEAE leading to study and/or treatment withdrawal</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>Any TEAE leading to death</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>Any Infusion Related Reaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Observed SOBI003 Serum Concentration Immediately Before the Start of Infusion of SOBI003</title>
        <description>The observed SOBI003 serum concentration immediately before the start of infusion of SOBI003 (CPre-dose) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
        <time_frame>Weeks 38, 52, 78 and 104</time_frame>
        <population>The table report number of available pharmacokinetic (PK) samples</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>The Observed SOBI003 Serum Concentration Immediately Before the Start of Infusion of SOBI003</title>
          <description>The observed SOBI003 serum concentration immediately before the start of infusion of SOBI003 (CPre-dose) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
          <population>The table report number of available pharmacokinetic (PK) samples</population>
          <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="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 38 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="120.0" spread="NA">Only one sample analyzed</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Week 78 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.0" spread="NA">Only one sample analyzed</measurement>
                    <measurement group_id="O2" value="75.0" spread="NA">Only one sample analyzed</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2610" spread="NA">Only one sample analyzed</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 38 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49" spread="NA">Only one sample analyzed</measurement>
                    <measurement group_id="O2" value="30" spread="14.142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="123" spread="NA">Only one sample analyzed</measurement>
                    <measurement group_id="O2" value="11770" spread="16312"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 78 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="208.5" spread="234.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="765.5" spread="125.16"/>
                    <measurement group_id="O2" value="66.33" spread="49.571"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Observed SOBI003 Serum Concentration at the End of Infusion of SOBI003</title>
        <description>The observed SOBI003 serum concentration at the end of infusion of SOBI003 (CEnd of inf) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
        <time_frame>Weeks 38, 52, 78 and 104</time_frame>
        <population>The table report number of available pharmacokinetic (PK) samples</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>The Observed SOBI003 Serum Concentration at the End of Infusion of SOBI003</title>
          <description>The observed SOBI003 serum concentration at the end of infusion of SOBI003 (CEnd of inf) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
          <population>The table report number of available pharmacokinetic (PK) samples</population>
          <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="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 38 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="210000" spread="NA">Only one sample analyzed</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 38 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14370" spread="14583"/>
                    <measurement group_id="O2" value="109500" spread="3535.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7900" spread="NA">Only one sample analyzed</measurement>
                    <measurement group_id="O2" value="203000" spread="NA">Only one sample analyzed</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72000" spread="37194"/>
                    <measurement group_id="O2" value="86510" spread="122320"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 78 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Week 78 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74450" spread="105310"/>
                    <measurement group_id="O2" value="229500" spread="101120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79700" spread="NA">Only one sample analyzed</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="292599" spread="37477"/>
                    <measurement group_id="O2" value="195000" spread="72125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Time of the End of the Infusion of SOBI003</title>
        <description>The time of the end of infusion of SOBI003 (tEnd of inf) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
        <time_frame>Weeks 38, 52, 78 and 104</time_frame>
        <population>Number of analysed are available samples</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>The Time of the End of the Infusion of SOBI003</title>
          <description>The time of the end of infusion of SOBI003 (tEnd of inf) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
          <population>Number of analysed are available samples</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 38 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="6.20" lower_limit="6.20" upper_limit="6.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.50" lower_limit="4.50" upper_limit="4.50"/>
                    <measurement group_id="O2" value="4.170" lower_limit="4.17" upper_limit="4.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 78 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Week 104 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.47" lower_limit="4.47" upper_limit="4.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 38 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="4.08" upper_limit="6.25"/>
                    <measurement group_id="O2" value="4.825" lower_limit="4.33" upper_limit="5.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52- peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.775" lower_limit="4.08" upper_limit="5.47"/>
                    <measurement group_id="O2" value="5.845" lower_limit="4.17" upper_limit="7.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 78- peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.50" lower_limit="4.18" upper_limit="5.88"/>
                    <measurement group_id="O2" value="8.575" lower_limit="4.73" upper_limit="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104- peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.030" lower_limit="4.03" upper_limit="6.03"/>
                    <measurement group_id="O2" value="8.540" lower_limit="4.25" upper_limit="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Maximum Observed Serum Concentration of SOBI003</title>
        <description>The maximum observed serum concentration of SOBI003 (Cmax) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
        <time_frame>Weeks 38, 52, 78 and 104</time_frame>
        <population>Number of analysed are available samples</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>The Maximum Observed Serum Concentration of SOBI003</title>
          <description>The maximum observed serum concentration of SOBI003 (Cmax) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
          <population>Number of analysed are available samples</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 38 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="105000" lower_limit="32.0" upper_limit="210000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="203000" lower_limit="203000" upper_limit="203000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 78 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="136.0" lower_limit="136.0" upper_limit="136.0"/>
                    <measurement group_id="O2" value="75.0" lower_limit="75.0" upper_limit="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79700" lower_limit="79700" upper_limit="79700"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 38 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7690" lower_limit="4330" upper_limit="31100"/>
                    <measurement group_id="O2" value="109500" lower_limit="107000" upper_limit="112000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45700" lower_limit="154" upper_limit="98300"/>
                    <measurement group_id="O2" value="23300" lower_limit="11600" upper_limit="173000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 78 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="195000" lower_limit="28000" upper_limit="243000"/>
                    <measurement group_id="O2" value="229500" lower_limit="158000" upper_limit="301000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="292500" lower_limit="266000" upper_limit="319000"/>
                    <measurement group_id="O2" value="144000" lower_limit="25000" upper_limit="246000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Time at Which the Maximum Serum Concentration of SOBI003 is Observed</title>
        <description>The time after start of infusion at which the maximum serum concentration is observed (tmax) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
        <time_frame>Weeks 38, 52, 78 and 104</time_frame>
        <population>Number of analysed are available samples</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>The Time at Which the Maximum Serum Concentration of SOBI003 is Observed</title>
          <description>The time after start of infusion at which the maximum serum concentration is observed (tmax) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
          <population>Number of analysed are available samples</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 38 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="87.96" lower_limit="8.17" upper_limit="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.50" lower_limit="4.50" upper_limit="4.50"/>
                    <measurement group_id="O2" value="4.170" lower_limit="4.170" upper_limit="4.170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 78 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168" lower_limit="168" upper_limit="168"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.47" lower_limit="4.47" upper_limit="4.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 38 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="4.08" upper_limit="6.25"/>
                    <measurement group_id="O2" value="4.825" lower_limit="4.33" upper_limit="5.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.47" lower_limit="4.08" upper_limit="26.5"/>
                    <measurement group_id="O2" value="7.52" lower_limit="0" upper_limit="24.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 78 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.88" lower_limit="4.5" upper_limit="168"/>
                    <measurement group_id="O2" value="8.575" lower_limit="4.73" upper_limit="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.03" lower_limit="4.03" upper_limit="6.03"/>
                    <measurement group_id="O2" value="12.83" lower_limit="4.25" upper_limit="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Minimum Observed Serum Concentration of SOBI003</title>
        <description>The minimum observed serum concentration of SOBI003 (CTrough) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
        <time_frame>Weeks 38, 52, 78 and 104</time_frame>
        <population>Number of analysed are available samples</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>The Minimum Observed Serum Concentration of SOBI003</title>
          <description>The minimum observed serum concentration of SOBI003 (CTrough) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
          <population>Number of analysed are available samples</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 38 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="68.0" lower_limit="32.0" upper_limit="104.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Week 78 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.0" lower_limit="47.0" upper_limit="47.0"/>
                    <measurement group_id="O2" value="75.0" lower_limit="75.0" upper_limit="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2610" lower_limit="2610" upper_limit="2610"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 38 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34" lower_limit="34" upper_limit="34"/>
                    <measurement group_id="O2" value="30" lower_limit="20" upper_limit="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="138.5" lower_limit="123" upper_limit="154"/>
                    <measurement group_id="O2" value="25" lower_limit="11" upper_limit="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 78 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="362" lower_limit="43" upper_limit="28000"/>
                    <measurement group_id="O2" value="85" lower_limit="85" upper_limit="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="704.5" lower_limit="555" upper_limit="854"/>
                    <measurement group_id="O2" value="75" lower_limit="13" upper_limit="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clearance</title>
        <description>Clearance (CL) of SOBI003 Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
        <time_frame>Weeks 38, 52, 78 and 104</time_frame>
        <population>Number of analysed are available samples</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Clearance</title>
          <description>Clearance (CL) of SOBI003 Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
          <population>Number of analysed are available samples</population>
          <units>mL/min</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 38 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Week 52 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Week 78 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="208" lower_limit="208" upper_limit="208"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" lower_limit="1.6" upper_limit="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 38 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.661" lower_limit="0.661" upper_limit="0.661"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.51" lower_limit="3.51" upper_limit="3.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 78 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Week 104 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.21" lower_limit="2.21" upper_limit="2.21"/>
                    <measurement group_id="O2" value="3.61" lower_limit="3.61" upper_limit="3.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the SOBI003 Serum Concentration-time Curve From Time 0 to168 Hours</title>
        <description>Area under the SOBI003 serum concentration-time curve from time 0 to 168 hours (AUC 0-168h) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
        <time_frame>0,1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post-dose on Weeks 38, 52, 78 and 104</time_frame>
        <population>Number of analysed are available samples</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the SOBI003 Serum Concentration-time Curve From Time 0 to168 Hours</title>
          <description>Area under the SOBI003 serum concentration-time curve from time 0 to 168 hours (AUC 0-168h) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
          <population>Number of analysed are available samples</population>
          <units>h*ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 38 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Week 52 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Week 78 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15400" lower_limit="15400" upper_limit="15400"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104 - central serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2040000" lower_limit="2040000" upper_limit="2040000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 38 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2880000" lower_limit="2880000" upper_limit="2880000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1110000" lower_limit="1110000" upper_limit="1110000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 78 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Week 104 - peripheral serum</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4390000" lower_limit="4390000" upper_limit="4390000"/>
                    <measurement group_id="O2" value="2770000" lower_limit="2770000" upper_limit="2770000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Half-life</title>
        <description>The half-life of SOBI003 in serum (T1/2) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
        <time_frame>Weeks 38, 52, 78 and 104</time_frame>
        <population>Number of analysed are available samples</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>The Half-life</title>
          <description>The half-life of SOBI003 in serum (T1/2) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.</description>
          <population>Number of analysed are available samples</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 38 - central serum</title>
            </class>
            <class>
              <title>Week 52 - central serum</title>
            </class>
            <class>
              <title>Week 78 - central serum</title>
            </class>
            <class>
              <title>Week 104 - central serum</title>
            </class>
            <class>
              <title>Week 38 - peripheral serum</title>
            </class>
            <class>
              <title>Week 52 - peripheral serum</title>
            </class>
            <class>
              <title>Week 78 - peripheral serum</title>
            </class>
            <class>
              <title>Week 104 - peripheral serum</title>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>SOBI003 Concentration in Cerebrospinal Fluid</title>
        <description>Concentration of SOBI003 in cerebrospinal fluid</description>
        <time_frame>Weeks 52 and 104</time_frame>
        <population>Number analysed are available samples</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>SOBI003 Concentration in Cerebrospinal Fluid</title>
          <description>Concentration of SOBI003 in cerebrospinal fluid</description>
          <population>Number analysed are available samples</population>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.7" lower_limit="15.7" upper_limit="15.7"/>
                    <measurement group_id="O2" value="92.3" lower_limit="73.6" upper_limit="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118.35" lower_limit="95.7" upper_limit="141.0"/>
                    <measurement group_id="O2" value="57.1" lower_limit="41.5" upper_limit="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Having Anti-drug Antibodies in Serum</title>
        <description>Number of patients in each dose group having anti-drug antibodies in serum</description>
        <time_frame>Weeks 38, 52, 78 and 104</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Having Anti-drug Antibodies in Serum</title>
          <description>Number of patients in each dose group having anti-drug antibodies in serum</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 38</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 78</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>Week 104</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Having Anti-drug Antibodies in Cerebrospinal Fluid</title>
        <description>Number of patients in each dose group having anti-drug antibodies cerebrospinal fluid</description>
        <time_frame>Weeks 52 and 104</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Having Anti-drug Antibodies in Cerebrospinal Fluid</title>
          <description>Number of patients in each dose group having anti-drug antibodies cerebrospinal fluid</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Heparan Sulfate Concentration in Cerebrospinal Fluid</title>
        <description>Change from baseline, in percent, of Heparan Sulfate levels in cerebrospinal fluid</description>
        <time_frame>Weeks 52 and 104</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Heparan Sulfate Concentration in Cerebrospinal Fluid</title>
          <description>Change from baseline, in percent, of Heparan Sulfate levels in cerebrospinal fluid</description>
          <units>mg/L</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.19" lower_limit="-4.91" upper_limit="0.1"/>
                    <measurement group_id="O2" value="-3.47" lower_limit="-23.2" upper_limit="-2.579"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.07" lower_limit="-6.67" upper_limit="-4.42"/>
                    <measurement group_id="O2" value="-3.59" lower_limit="-24.7" upper_limit="-2.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Heparan Sulfate Levels in Serum</title>
        <description>Change from baseline in Heparan sulfate, in mg/L, levels in serum</description>
        <time_frame>Weeks 38, 52, 78 and 104</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Heparan Sulfate Levels in Serum</title>
          <description>Change from baseline in Heparan sulfate, in mg/L, levels in serum</description>
          <units>mg/L</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 38</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.811" lower_limit="-2.168" upper_limit="-1.793"/>
                    <measurement group_id="O2" value="-1.88" lower_limit="-3.721" upper_limit="-1.854"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.76" lower_limit="-2.169" upper_limit="-1.644"/>
                    <measurement group_id="O2" value="-2.25" lower_limit="-3.735" upper_limit="-1.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 78</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.729" lower_limit="-2.41" upper_limit="-1.686"/>
                    <measurement group_id="O2" value="-2.01" lower_limit="-3.05" upper_limit="-0.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.21" lower_limit="-2.41" upper_limit="0.21"/>
                    <measurement group_id="O2" value="-2.24" lower_limit="-3.708" upper_limit="-1.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Heparan Sulfate Levels in Urine</title>
        <description>Change from baseline in Heparan sulfate levels, in g/mol, in urine</description>
        <time_frame>Weeks 38, 52, 78 and 104</time_frame>
        <population>Number of analysed are available samples</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Heparan Sulfate Levels in Urine</title>
          <description>Change from baseline in Heparan sulfate levels, in g/mol, in urine</description>
          <population>Number of analysed are available samples</population>
          <units>g/mol</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 38</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-447.2" lower_limit="-552.82" upper_limit="-340.1"/>
                    <measurement group_id="O2" value="-692.78" lower_limit="-697.12" upper_limit="-382.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-464.4" lower_limit="-559.02" upper_limit="-411.67"/>
                    <measurement group_id="O2" value="-698.79" lower_limit="-701.99" upper_limit="-388.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 78</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-512.19" lower_limit="-599.70" upper_limit="-424.68"/>
                    <measurement group_id="O2" value="-494.610" lower_limit="-747.22" upper_limit="-242.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-578.89" lower_limit="-709.47" upper_limit="-489.68"/>
                    <measurement group_id="O2" value="-726.24" lower_limit="-753.97" upper_limit="-381.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Neurocognitive Development Quotient</title>
        <description>Quotient between age equivalent score and age, 0 - 100%, where high values are desirable. The age equivalent score represent the age of the typical and normal individual who would achieve the same result as the one who was tested The age equivalent scores are assessed by the Bayley Scales of Infant and Toddler Development®, third edition cognitive subtest or the Kaufman Assessment Battery for Children, Second edition.&#xD;
The Bayley Scales of Infant and Toddler Development-Third Edition is an individually administered test designed to assess developmental functioning of infants and toddlers. The Bayley-III assesses development in five areas: cognitive, language, motor,social-emotional, and adaptive behavior.&#xD;
The Kaufman Assessment Battery for Children (K-ABC) is a clinical instrument for assessing cognitive development.&#xD;
These results are truly &quot;unitless&quot;/&quot;dimensionless&quot; because they represents quotients of values from the same scale, which means that the units in the denominator and</description>
        <time_frame>Weeks 52 and 104</time_frame>
        <population>Number of analysed are number of assessments</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Neurocognitive Development Quotient</title>
          <description>Quotient between age equivalent score and age, 0 - 100%, where high values are desirable. The age equivalent score represent the age of the typical and normal individual who would achieve the same result as the one who was tested The age equivalent scores are assessed by the Bayley Scales of Infant and Toddler Development®, third edition cognitive subtest or the Kaufman Assessment Battery for Children, Second edition.&#xD;
The Bayley Scales of Infant and Toddler Development-Third Edition is an individually administered test designed to assess developmental functioning of infants and toddlers. The Bayley-III assesses development in five areas: cognitive, language, motor,social-emotional, and adaptive behavior.&#xD;
The Kaufman Assessment Battery for Children (K-ABC) is a clinical instrument for assessing cognitive development.&#xD;
These results are truly &quot;unitless&quot;/&quot;dimensionless&quot; because they represents quotients of values from the same scale, which means that the units in the denominator and</description>
          <population>Number of analysed are number of assessments</population>
          <units>Unitless</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.97" lower_limit="-18" upper_limit="-6.9"/>
                    <measurement group_id="O2" value="-31.74" lower_limit="-48.9" upper_limit="-14.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.28" lower_limit="-32.9" upper_limit="-11.7"/>
                    <measurement group_id="O2" value="-24.94" lower_limit="-44.6" upper_limit="-11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Age-equivalence Score</title>
        <description>The age equivalent score represent the age in months of the typical and normal individual who would achieve the same result as the one who was tested. The age equivalent scores are assessed by the Bayley Scales of Infant and Toddler Development®, third edition cognitive subtest or the Kaufman Assessment Battery for Children, Second edition. The Bayley Scales of Infant and Toddler Development-Third Edition is an individually administered test designed to assess developmental functioning of infants and toddlers. The Bayley-III assesses development in five areas: cognitive, language, motor, social-emotional, and adaptive behavior. The Kaufman Assessment Battery for Children (K-ABC) is a clinical instrument for assessing cognitive development.</description>
        <time_frame>Week 52 and 104</time_frame>
        <population>Number of analyses are available assessments</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Age-equivalence Score</title>
          <description>The age equivalent score represent the age in months of the typical and normal individual who would achieve the same result as the one who was tested. The age equivalent scores are assessed by the Bayley Scales of Infant and Toddler Development®, third edition cognitive subtest or the Kaufman Assessment Battery for Children, Second edition. The Bayley Scales of Infant and Toddler Development-Third Edition is an individually administered test designed to assess developmental functioning of infants and toddlers. The Bayley-III assesses development in five areas: cognitive, language, motor, social-emotional, and adaptive behavior. The Kaufman Assessment Battery for Children (K-ABC) is a clinical instrument for assessing cognitive development.</description>
          <population>Number of analyses are available assessments</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" lower_limit="-2" upper_limit="2"/>
                    <measurement group_id="O2" value="-1.0" lower_limit="-2" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.0" lower_limit="-4" upper_limit="1"/>
                    <measurement group_id="O2" value="5.0" lower_limit="-1" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Age-equivalence Score as Assessed Either by the BSID-III, Cognitive Subtest, or the KABC-II.</title>
        <description>The age equivalent score represent the age in months of the typical and normal individual who would achieve the same result as the one who was tested. The age equivalent scores are assessed by Vineland™ Adaptive Behavior Scales, Expanded Interview Form, Second edition (VABS-II). The Vineland is designed to measure adaptive behavior of individuals from birth to age 90. The Vineland-II contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior.</description>
        <time_frame>Week 52 and 104</time_frame>
        <population>Number of analyses are available assessments</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Age-equivalence Score as Assessed Either by the BSID-III, Cognitive Subtest, or the KABC-II.</title>
          <description>The age equivalent score represent the age in months of the typical and normal individual who would achieve the same result as the one who was tested. The age equivalent scores are assessed by Vineland™ Adaptive Behavior Scales, Expanded Interview Form, Second edition (VABS-II). The Vineland is designed to measure adaptive behavior of individuals from birth to age 90. The Vineland-II contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior.</description>
          <population>Number of analyses are available assessments</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0" lower_limit="10" upper_limit="31"/>
                    <measurement group_id="O2" value="16.0" lower_limit="12" upper_limit="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.0" lower_limit="8" upper_limit="29"/>
                    <measurement group_id="O2" value="19.0" lower_limit="19" upper_limit="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Age-equivalence Score as Assessed Either by the BSID-III, Cognitive Subtest, or the KABC-II.</title>
        <description>The age equivalent score represents the age in months of the typical and normal individual who would achieve the same result as the one who was tested.&#xD;
The age equivalent scores are assessed either by the Bayley Scales of Infant and Toddler Development®, third edition, (BSID-III) cognitive subtest or the Kaufman Assessment Battery for Children, Second edition (KABC-II) depending on chronological age of the subject. Quotient between age equivalent score and age, 0 - 100%, where high values are desirable.&#xD;
The BSID-III is an individually administered test designed to assess developmental functioning of infants and toddlers. The BSID-III assesses development in five areas: cognitive, language, motor, social-emotional, and adaptive behavior.&#xD;
The KABC-II is a clinical instrument for assessing cognitive development. The unit and measurement is the same in both scales (BSID-III and KABC-II): Age-equivalent score.</description>
        <time_frame>Week 52 and 104</time_frame>
        <population>Number of analysed are available assessments</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Age-equivalence Score as Assessed Either by the BSID-III, Cognitive Subtest, or the KABC-II.</title>
          <description>The age equivalent score represents the age in months of the typical and normal individual who would achieve the same result as the one who was tested.&#xD;
The age equivalent scores are assessed either by the Bayley Scales of Infant and Toddler Development®, third edition, (BSID-III) cognitive subtest or the Kaufman Assessment Battery for Children, Second edition (KABC-II) depending on chronological age of the subject. Quotient between age equivalent score and age, 0 - 100%, where high values are desirable.&#xD;
The BSID-III is an individually administered test designed to assess developmental functioning of infants and toddlers. The BSID-III assesses development in five areas: cognitive, language, motor, social-emotional, and adaptive behavior.&#xD;
The KABC-II is a clinical instrument for assessing cognitive development. The unit and measurement is the same in both scales (BSID-III and KABC-II): Age-equivalent score.</description>
          <population>Number of analysed are available assessments</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" lower_limit="-2" upper_limit="2"/>
                    <measurement group_id="O2" value="-1.0" lower_limit="-2" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.0" lower_limit="-4" upper_limit="1"/>
                    <measurement group_id="O2" value="5.0" lower_limit="-1" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Age-equivalence Score as Assessed by VABS-II</title>
        <description>The age equivalent score represent the age in months of the typical and normal individual who would achieve the same result as the one who was tested.&#xD;
The age equivalent scores are assessed by Vineland™ Adaptive Behavior Scales, Expanded Interview Form, Second edition (VABS-II). The Vineland is designed to measure adaptive behavior of individuals from birth to age 90.&#xD;
The Vineland-II contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior.</description>
        <time_frame>Week 52 and 104</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Age-equivalence Score as Assessed by VABS-II</title>
          <description>The age equivalent score represent the age in months of the typical and normal individual who would achieve the same result as the one who was tested.&#xD;
The age equivalent scores are assessed by Vineland™ Adaptive Behavior Scales, Expanded Interview Form, Second edition (VABS-II). The Vineland is designed to measure adaptive behavior of individuals from birth to age 90.&#xD;
The Vineland-II contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior.</description>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15" lower_limit="15" upper_limit="26"/>
                    <measurement group_id="O2" value="28" lower_limit="13" upper_limit="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" lower_limit="13" upper_limit="21"/>
                    <measurement group_id="O2" value="23" lower_limit="20" upper_limit="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Age-equivalence Score as Assessed by VABS-II</title>
        <description>The age equivalent score represent the age in months of the typical and normal individual who would achieve the same result as the one who was tested.&#xD;
The age equivalent scores are assessed by Vineland™ Adaptive Behavior Scales, Expanded Interview Form, Second edition (VABS-II). The Vineland is designed to measure adaptive behavior of individuals from birth to age 90.&#xD;
The Vineland-II contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior.</description>
        <time_frame>Week 52 and 104</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Age-equivalence Score as Assessed by VABS-II</title>
          <description>The age equivalent score represent the age in months of the typical and normal individual who would achieve the same result as the one who was tested.&#xD;
The age equivalent scores are assessed by Vineland™ Adaptive Behavior Scales, Expanded Interview Form, Second edition (VABS-II). The Vineland is designed to measure adaptive behavior of individuals from birth to age 90.&#xD;
The Vineland-II contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior.</description>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1" lower_limit="-12" upper_limit="2"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6" lower_limit="-11" upper_limit="0"/>
                    <measurement group_id="O2" value="8" lower_limit="-5" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Gray Matter Volume</title>
        <description>Grey matter contains most of the brain's neuronal cell bodies. The grey matter includes regions of the brain involved in muscle control, and sensory perception such as seeing and hearing, memory, emotions, speech, decision making, and self-control. The gray matter volume will be measured by volumetric magnetic resonance imaging (MRI) at weeks 52 and 104.</description>
        <time_frame>Week 52 and 104</time_frame>
        <population>Number analysed is available assessments</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Gray Matter Volume</title>
          <description>Grey matter contains most of the brain's neuronal cell bodies. The grey matter includes regions of the brain involved in muscle control, and sensory perception such as seeing and hearing, memory, emotions, speech, decision making, and self-control. The gray matter volume will be measured by volumetric magnetic resonance imaging (MRI) at weeks 52 and 104.</description>
          <population>Number analysed is available assessments</population>
          <units>mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.629" lower_limit="-34.32" upper_limit="66.87"/>
                    <measurement group_id="O2" value="19.485" lower_limit="-62.32" upper_limit="101.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-53.584" lower_limit="-161.03" upper_limit="53.86"/>
                    <measurement group_id="O2" value="13.387" lower_limit="-45.41" upper_limit="72.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pediatric Quality of Life Inventory (PedsQL™) Total Score</title>
        <description>Pediatric Quality of Life Inventory (PedsQL™) is a modular approach to measuring health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. Lower scores indicate better functioning. Min score = 0, and max score = 144.</description>
        <time_frame>Week 52 and 104</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Pediatric Quality of Life Inventory (PedsQL™) Total Score</title>
          <description>Pediatric Quality of Life Inventory (PedsQL™) is a modular approach to measuring health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. Lower scores indicate better functioning. Min score = 0, and max score = 144.</description>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.4" spread="3.9"/>
                    <measurement group_id="O2" value="72.2" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.9" spread="10.2"/>
                    <measurement group_id="O2" value="76.5" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pediatric Quality of Life Inventory (PedsQL™) Total Score</title>
        <description>Pediatric Quality of Life Inventory (PedsQL™) is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. Higher scores indicate better functioning. Min score = 0, and max score = 144.</description>
        <time_frame>Week 52 and 104</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pediatric Quality of Life Inventory (PedsQL™) Total Score</title>
          <description>Pediatric Quality of Life Inventory (PedsQL™) is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. Higher scores indicate better functioning. Min score = 0, and max score = 144.</description>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.0" spread="25.9"/>
                    <measurement group_id="O2" value="-3.7" spread="24.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.5" spread="14.9"/>
                    <measurement group_id="O2" value="0.6" spread="21.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PedsQL™ Family Impact Module Total Score</title>
        <description>Pediatric Quality of Life Inventory (PedsQL™) is a modular approach to measuring health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. The Total Score is the sum of all 36 items in the test divided by the number of items answered. Higher scores indicate better functioning. Min score = 0, and max score = 144.</description>
        <time_frame>Week 52 and 104</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>PedsQL™ Family Impact Module Total Score</title>
          <description>Pediatric Quality of Life Inventory (PedsQL™) is a modular approach to measuring health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. The Total Score is the sum of all 36 items in the test divided by the number of items answered. Higher scores indicate better functioning. Min score = 0, and max score = 144.</description>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7" spread="30.6"/>
                    <measurement group_id="O2" value="70.0" spread="26.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.3" spread="34.0"/>
                    <measurement group_id="O2" value="70.0" spread="26.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in PedsQL™ Family Impact Module Total Score</title>
        <description>Pediatric Quality of Life Inventory (PedsQL™) is a modular approach to measuring health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. The Total Score is the sum of all 36 items in the test divided by the number of items answered. Higher scores indicate better functioning.</description>
        <time_frame>Week 52 and 104</time_frame>
        <population>Number analysed is available assessments</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Group 1</title>
            <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
          <group group_id="O2">
            <title>Dose Group 2</title>
            <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in PedsQL™ Family Impact Module Total Score</title>
          <description>Pediatric Quality of Life Inventory (PedsQL™) is a modular approach to measuring health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. The Total Score is the sum of all 36 items in the test divided by the number of items answered. Higher scores indicate better functioning.</description>
          <population>Number analysed is available assessments</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" spread="12.6"/>
                    <measurement group_id="O2" value="0.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 104</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.3" spread="31.8"/>
                    <measurement group_id="O2" value="0.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The period for recording adverse events, including Serious Adverse Events (SAEs), began Day 1 of week 25, when first dose in study SOBI003-002 was given, and ended at completion of week 104 visit. In addition SAEs was reported from the time of signing the informed consent form until 28 days past the last dose of SOBI003.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Dose Group 1</title>
          <description>SOBI003 initial dose 3 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
        </group>
        <group group_id="E2">
          <title>Dose Group 2</title>
          <description>SOBI003 initial dose 10 mg/kg, once weekly from infusion week 25 to week 104&#xD;
SOBI003: weekly i.v. infusion</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Incision site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic valve thickening</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Cyanosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="20" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="28" subjects_affected="3" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Auricular swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Otorrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Abnormal faeces</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Aphthous ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="10" subjects_affected="2" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Faeces discoloured</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Lip disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Oral contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Retching</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="17" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E2" events="22" subjects_affected="3" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Catheter site extravasation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Catheter site inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Catheter site injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Complication associated with device</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="6" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Infusion site bruising</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Infusion site irritation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Medical device site haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E2" events="11" subjects_affected="3" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Corona virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Streptococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="17" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E2" events="12" subjects_affected="2" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="8" subjects_affected="3" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="8" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Foreign body in gastrointestinal tract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Human bite</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Incision site haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Lip injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Scratch</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="6" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="10" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Soft tissue injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Vascular access complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Vascular access site occlusion</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="5" subjects_affected="2" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Activated partial thromboplastin time prolonged</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Blood fibrinogen increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Blood pressure diastolic increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Blood pressure systolic increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>CSF glucose decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>CSF protein increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Cardiac murmur</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Eosinophil count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Haemoglobin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Heart rate increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Monocyte count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Neutrophil count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Oxygen saturation decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="26" subjects_affected="2" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Red blood cell count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Vitamin D decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle tightness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Skin papilloma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ataxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Clonus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Drooling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="6" subjects_affected="2" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device damage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Device dislocation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Device malfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal behaviour</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="8" subjects_affected="2" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="10" subjects_affected="2" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Tachypnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="5" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Dermatitis diaper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="5" subjects_affected="2" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="22" subjects_affected="2" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Generalised erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="7" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hyperkeratosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Livedo reticularis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="13" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="13" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Skin discolouration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Skin fissures</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="20" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" events="20" subjects_affected="3" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hyperaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="4" subjects_affected="1" subjects_at_risk="3"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Communication</name_or_title>
      <organization>Sobi</organization>
      <phone>+4686972000</phone>
      <email>info@sobi.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/NCT03811028
org study id: SOBI003-002
nct id: NCT03811028
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
MPS IIIA, also known as Sanfilippo A, is an inherited lysosomal storage disease (LSD). MPS
      IIIA is caused by a deficiency in sulfamidase, one of the enzymes involved in the lysosomal
      degradation of the glycosaminoglycan (GAG) heparan sulfate (HS). The natural course of MPS
      IIIA is characterized by devastating neurodegeneration with initially mild somatic
      involvement. The aim of the present study is to assess the safety, tolerability and efficacy
      of long-term SOBI003 treatment. SOBI003 is a chemically modified recombinant human (rh)
      Sulfamidase developed as an enzyme replacement therapy (ERT).
This is an open, single-arm, multicenter extension study to assess the safety, tolerability
      and efficacy of long-term SOBI003 treatment in pediatric MPS IIIA patients. The study is an
      extension of the First in Human (FIH) SOBI003-001 study, allowing continuous treatment of
      SOBI003 for up to 2 years. Study patients who complete Week 24 of the FIH study (SOBI003-001)
      will be invited to continue to Week 25 in the extension study.

      When entering the extension study, these patients will receive the highest dose that has been
      declared safe in the ongoing FIH study (SOBI003-001). Upon completion of the FIH study, an
      analysis aimed at selecting the dose for forthcoming studies will take place. Once the dose
      has been selected, this dose will be applied to all patients enrolled in the extension study.
      The total duration of the extension study for an individual patient is 80 weeks, resulting in
      a total of 104 weeks (2 years) of SOBI003 treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety as Measured by Adverse Events Frequencies (by Type and Severity)
time frame: From infusion week 25 up to week 104
description: Number of adverse events, by type and severity, from week 25 up to week 104
measure: The Observed SOBI003 Serum Concentration Immediately Before the Start of Infusion of SOBI003
time frame: Weeks 38, 52, 78 and 104
description: The observed SOBI003 serum concentration immediately before the start of infusion of SOBI003 (CPre-dose) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.
measure: The Observed SOBI003 Serum Concentration at the End of Infusion of SOBI003
time frame: Weeks 38, 52, 78 and 104
description: The observed SOBI003 serum concentration at the end of infusion of SOBI003 (CEnd of inf) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.
measure: The Time of the End of the Infusion of SOBI003
time frame: Weeks 38, 52, 78 and 104
description: The time of the end of infusion of SOBI003 (tEnd of inf) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.
measure: The Maximum Observed Serum Concentration of SOBI003
time frame: Weeks 38, 52, 78 and 104
description: The maximum observed serum concentration of SOBI003 (Cmax) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.
measure: The Time at Which the Maximum Serum Concentration of SOBI003 is Observed
time frame: Weeks 38, 52, 78 and 104
description: The time after start of infusion at which the maximum serum concentration is observed (tmax) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.
measure: The Minimum Observed Serum Concentration of SOBI003
time frame: Weeks 38, 52, 78 and 104
description: The minimum observed serum concentration of SOBI003 (CTrough) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.
measure: Clearance
time frame: Weeks 38, 52, 78 and 104
description: Clearance (CL) of SOBI003 Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.
measure: Area Under the SOBI003 Serum Concentration-time Curve From Time 0 to168 Hours
time frame: 0,1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post-dose on Weeks 38, 52, 78 and 104
description: Area under the SOBI003 serum concentration-time curve from time 0 to 168 hours (AUC 0-168h) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.
measure: The Half-life
time frame: Weeks 38, 52, 78 and 104
description: The half-life of SOBI003 in serum (T1/2) Blood samples for serum PK analysis were collected either by centrally (i.e., using a catheter in the central venous port) or peripheral (i.e., by venipuncture). Central venous sampling is more convenient than repeated venipuncture.
measure: SOBI003 Concentration in Cerebrospinal Fluid
time frame: Weeks 52 and 104
description: Concentration of SOBI003 in cerebrospinal fluid
measure: Number of Patients Having Anti-drug Antibodies in Serum
time frame: Weeks 38, 52, 78 and 104
description: Number of patients in each dose group having anti-drug antibodies in serum
measure: Number of Patients Having Anti-drug Antibodies in Cerebrospinal Fluid
time frame: Weeks 52 and 104
description: Number of patients in each dose group having anti-drug antibodies cerebrospinal fluid
measure: Change From Baseline in Heparan Sulfate Concentration in Cerebrospinal Fluid
time frame: Weeks 52 and 104
description: Change from baseline, in percent, of Heparan Sulfate levels in cerebrospinal fluid
measure: Change From Baseline in Heparan Sulfate Levels in Serum
time frame: Weeks 38, 52, 78 and 104
description: Change from baseline in Heparan sulfate, in mg/L, levels in serum
measure: Change From Baseline in Heparan Sulfate Levels in Urine
time frame: Weeks 38, 52, 78 and 104
description: Change from baseline in Heparan sulfate levels, in g/mol, in urine
measure: Change From Baseline in Neurocognitive Development Quotient
time frame: Weeks 52 and 104
description: Quotient between age equivalent score and age, 0 - 100%, where high values are desirable. The age equivalent score represent the age of the typical and normal individual who would achieve the same result as the one who was tested The age equivalent scores are assessed by the Bayley Scales of Infant and Toddler Development®, third edition cognitive subtest or the Kaufman Assessment Battery for Children, Second edition.
The Bayley Scales of Infant and Toddler Development-Third Edition is an individually administered test designed to assess developmental functioning of infants and toddlers. The Bayley-III assesses development in five areas: cognitive, language, motor,social-emotional, and adaptive behavior.
The Kaufman Assessment Battery for Children (K-ABC) is a clinical instrument for assessing cognitive development.
These results are truly "unitless"/"dimensionless" because they represents quotients of values from the same scale, which means that the units in the denominator and
measure: Change From Baseline in Age-equivalence Score
time frame: Week 52 and 104
description: The age equivalent score represent the age in months of the typical and normal individual who would achieve the same result as the one who was tested. The age equivalent scores are assessed by the Bayley Scales of Infant and Toddler Development®, third edition cognitive subtest or the Kaufman Assessment Battery for Children, Second edition. The Bayley Scales of Infant and Toddler Development-Third Edition is an individually administered test designed to assess developmental functioning of infants and toddlers. The Bayley-III assesses development in five areas: cognitive, language, motor, social-emotional, and adaptive behavior. The Kaufman Assessment Battery for Children (K-ABC) is a clinical instrument for assessing cognitive development.
measure: Age-equivalence Score as Assessed Either by the BSID-III, Cognitive Subtest, or the KABC-II.
time frame: Week 52 and 104
description: The age equivalent score represent the age in months of the typical and normal individual who would achieve the same result as the one who was tested. The age equivalent scores are assessed by Vineland™ Adaptive Behavior Scales, Expanded Interview Form, Second edition (VABS-II). The Vineland is designed to measure adaptive behavior of individuals from birth to age 90. The Vineland-II contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior.
measure: Change From Baseline in Age-equivalence Score as Assessed Either by the BSID-III, Cognitive Subtest, or the KABC-II.
time frame: Week 52 and 104
description: The age equivalent score represents the age in months of the typical and normal individual who would achieve the same result as the one who was tested.
The age equivalent scores are assessed either by the Bayley Scales of Infant and Toddler Development®, third edition, (BSID-III) cognitive subtest or the Kaufman Assessment Battery for Children, Second edition (KABC-II) depending on chronological age of the subject. Quotient between age equivalent score and age, 0 - 100%, where high values are desirable.
The BSID-III is an individually administered test designed to assess developmental functioning of infants and toddlers. The BSID-III assesses development in five areas: cognitive, language, motor, social-emotional, and adaptive behavior.
The KABC-II is a clinical instrument for assessing cognitive development. The unit and measurement is the same in both scales (BSID-III and KABC-II): Age-equivalent score.
measure: Age-equivalence Score as Assessed by VABS-II
time frame: Week 52 and 104
description: The age equivalent score represent the age in months of the typical and normal individual who would achieve the same result as the one who was tested.
The age equivalent scores are assessed by Vineland™ Adaptive Behavior Scales, Expanded Interview Form, Second edition (VABS-II). The Vineland is designed to measure adaptive behavior of individuals from birth to age 90.
The Vineland-II contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior.
measure: Change From Baseline in Age-equivalence Score as Assessed by VABS-II
time frame: Week 52 and 104
description: The age equivalent score represent the age in months of the typical and normal individual who would achieve the same result as the one who was tested.
The age equivalent scores are assessed by Vineland™ Adaptive Behavior Scales, Expanded Interview Form, Second edition (VABS-II). The Vineland is designed to measure adaptive behavior of individuals from birth to age 90.
The Vineland-II contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior.
measure: Change From Baseline in Gray Matter Volume
time frame: Week 52 and 104
description: Grey matter contains most of the brain's neuronal cell bodies. The grey matter includes regions of the brain involved in muscle control, and sensory perception such as seeing and hearing, memory, emotions, speech, decision making, and self-control. The gray matter volume will be measured by volumetric magnetic resonance imaging (MRI) at weeks 52 and 104.
measure: Pediatric Quality of Life Inventory (PedsQL™) Total Score
time frame: Week 52 and 104
description: Pediatric Quality of Life Inventory (PedsQL™) is a modular approach to measuring health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. Lower scores indicate better functioning. Min score = 0, and max score = 144.
measure: Change From Baseline in Pediatric Quality of Life Inventory (PedsQL™) Total Score
time frame: Week 52 and 104
description: Pediatric Quality of Life Inventory (PedsQL™) is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. Higher scores indicate better functioning. Min score = 0, and max score = 144.
measure: PedsQL™ Family Impact Module Total Score
time frame: Week 52 and 104
description: Pediatric Quality of Life Inventory (PedsQL™) is a modular approach to measuring health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. The Total Score is the sum of all 36 items in the test divided by the number of items answered. Higher scores indicate better functioning. Min score = 0, and max score = 144.
measure: Change From Baseline in PedsQL™ Family Impact Module Total Score
time frame: Week 52 and 104
description: Pediatric Quality of Life Inventory (PedsQL™) is a modular approach to measuring health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. The Total Score is the sum of all 36 items in the test divided by the number of items answered. Higher scores indicate better functioning.
arm group label: SOBI003
arm group type: Experimental
description: SOBI003 solution, 20 mg/mL, is mixed with NaCl 0.9% infusion solution prior to administration. For a bodyweight < 25 kg, the total infusion volume is 100 mL. For a bodyweight ≥ 25 kg, the total infusion volume is 250 mL.
SOBI003 is administered as i.v. infusions given once weekly for a duration of 80 weeks (from Week 25 until Week 104 following the first 24 weeks of SOBI003 administration in the FIH study (SOBI003-001) study. The SOBI003 dose will be adjusted to the highest dose that has been declared safe by the safety review committee on the FIH study.Hence, dose adjustments may occur a couple of times on the extension study until the final decided dose has been determined.
intervention type: Drug
intervention name: SOBI003
description: weekly i.v. infusion
arm group label: SOBI003
other name: Modified recombinant human sulphamidase
criteria: 
gender: All
minimum age: 18 Months
maximum age: 78 Months
healthy volunteers: No
last name: Paul Harmatz, MD
role: Principal Investigator
affiliation: Children´s Hospital and Research Center, Oakland
facility: 
facility: 
facility: 
country: Turkey
country: United States
responsible party type: Sponsor
mesh term: Mucopolysaccharidosis III
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 