<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/NCT03760913</url>
  </required_header>
  <id_info>
    <org_study_id>OLP-1002-001</org_study_id>
    <nct_id>NCT03760913</nct_id>
  </id_info>
  <brief_title>OLP-1002 is Being Studied in the Treatment of Pain.</brief_title>
  <official_title>OLP-1002 - A First-in-human, Double-blind, Placebo-controlled, Single and Multiple Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OliPass Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>OliPass Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to assess the safety and tolerability of single and&#xD;
      multiple subcutaneous doses of OLP-1002 in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The exploratory objectives of the study are to evaluate the pharmacodynamic effect of&#xD;
      OLP-1002 following single subcutaneous doses in healthy volunteers using a capsaicin pain&#xD;
      model, and to monitor the effects of a single subcutaneous doses of OLP-1002 on cardiac QT&#xD;
      interval. Where possible, single and/or multiple subcutaneous dose pharmacokinetics of&#xD;
      OLP-1002 in healthy subjects will be determined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 21, 2018</start_date>
  <completion_date type="Actual">October 16, 2020</completion_date>
  <primary_completion_date type="Actual">October 16, 2020</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This will be a double-blind, randomized, placebo-controlled, single and multiple subcutaneous dose study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events Stratified by Overall and Severity</measure>
    <time_frame>Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.</time_frame>
    <description>Participants were observed for any signs or symptoms of adverse events and asked about their condition by open questioning, such as &quot;How have you been feeling since you were last asked?&quot;, at least once each day while resident at the study site and at each study visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure</measure>
    <time_frame>Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.</time_frame>
    <description>Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in supine diastolic and systolic blood pressure.&#xD;
Participants were supine for at least 5 minutes before blood pressure measurements. Blood pressure was measured in triplicate and the time of measurement are below:&#xD;
Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15&#xD;
No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant supine blood pressure.&#xD;
Supine diastolic blood pressure reference range: 90 to 140 mmHg. Supine systolic blood pressure reference range: 50 to 90 mmHg.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate</measure>
    <time_frame>Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.</time_frame>
    <description>Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in supine pulse rate.&#xD;
Participants were supine for at least 5 minutes before pulse rate measurements. Pulse rate was measured in triplicate and the time of measurement are below:&#xD;
Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15&#xD;
No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant supine pulse rate.&#xD;
Reference range: 40 to 100 beats per minute.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate</measure>
    <time_frame>Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.</time_frame>
    <description>Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in respiratory rate.&#xD;
Participants were supine for at least 5 minutes before respiratory rate measurements. Respiratory rate was measured in triplicate and the time of measurement are below:&#xD;
Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15&#xD;
No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant respiratory rate.&#xD;
Reference range: 10 to 24 breaths per minute.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>12-lead Electrocardiogram Parameters</measure>
    <time_frame>Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.</time_frame>
    <description>Resting 12-lead electrocardiogram parameters were recorded after the participant had been supine and at rest for at least 5 minutes.&#xD;
Baseline: the last value recorded prior to first dose; QTcB: QT interval corrected for heart rate using Bazett's formula; QTcF: QT interval corrected for heart rate using Fridericia's method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results</measure>
    <time_frame>Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.</time_frame>
    <description>Number of participants with findings of clinical importance in clinical chemistry, hematology, and urinalysis test results.&#xD;
Clinical laboratory evaluations included:&#xD;
Clinical chemistry: Alanine aminotransferase; Albumin; Alkaline phosphatase; Aspartate aminotransferase; Calcium; Chloride; Cholesterol; Creatinine; Direct bilirubin; Gamma-glutamyl transferase; Glucose; Inorganic phosphate; Potassium; Sodium; Total bilirubin; Total protein; Urea Hematology: Hematocrit; Hemoglobin; Mean cell hemoglobin; Mean cell hemoglobin concentration; Mean cell volume; Platelet count; Red blood cell count; White blood cell count; White blood cell differential (Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils) Urinalysis: Blood; Glucose; Ketones; pH; Protein; Specific gravity; Urobilinogen; Microscopic examination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Full and Symptom-Directed Physical Examination Results</measure>
    <time_frame>Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.</time_frame>
    <description>A full physical examination and symptom-directed physical examinations were performed at specified timepoints.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Injection Site Assessment Results</measure>
    <time_frame>Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.</time_frame>
    <description>Evaluation of the dosing site for the following:&#xD;
Pain: Grade 0 to 4 Redness (assessed by estimating the size of the red patch at the injection site across its widest point): Grade 0: 0-24 mm; Grade 1: 25-50 mm; Grade 2: 51-100 mm; Grade 3: More than 100 mm; Grade 4: Requires medical intervention greater than analgesia Swelling (assessed by estimating the size of the raised area around the injection site across its widest point): Grade 0: 0-24 mm; Grade 1: 25-50 mm and does not interfere with activity; Grade 2: 51-100 mm or interferes with activity; Grade 3: More than 100 mm and prevents daily activity; Grade 4: Requires medical intervention greater than analgesia Tenderness: Grade 0 to 4&#xD;
Bruising and ulceration were evaluated as present or absent.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies</measure>
    <time_frame>Part A: Day 1 postdose. Part B: Day 1 postdose and Day 13 postdose.</time_frame>
    <description>Participants were assessed to demonstrate that exposure to OLP-1002 did not exceed pre-defined exposure limits from non-clinical studies. Participants with temporary detected plasma concentrations between the low limit of detection [0.2 ng/mL] and lower limit of quantification [1 ng/mL] are presented in the results.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">116</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>OLP-1002: Part A, Single Ascending Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subcutaneous Injection: 30 ng, 120 ng, 400 ng, 1.2 μg, 3 μg, 6 μg, 12 μg, 20 μg, 40 μg, 80 μg, 160 μg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OLP-1002: Part B, Multiple Ascending Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subcutaneous Injection: 5 x 2 μg, 5 x 5 μg, 5 x 10 μg, 5 x 20 μg, 5 x 40 μg, 5 x 80 μg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Part A, Single Ascending Dose</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subcutaneous Injection: Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Part B, Multiple Ascending Dose</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subcutaneous Injection: Placebo x 5</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OLP-1002 (Test): Part A, Single Ascending Dose</intervention_name>
    <description>Subcutaneous Injection: 30 ng, 120 ng, 400 ng, 1.2 µg, 3 µg, 6 µg, 12 µg, 20 µg, 40 μg, 80 μg, 160 μg</description>
    <arm_group_label>OLP-1002: Part A, Single Ascending Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OLP-1002 (Test): Part B, Multiple Ascending Dose</intervention_name>
    <description>Subcutaneous Injection: 5 x 2 μg, 5 x 5 μg, 5 x 10 μg, 5 x 20 μg, 5 x 40 μg, 5 x 80 μg</description>
    <arm_group_label>OLP-1002: Part B, Multiple Ascending Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo: Placebo Part A, Single Ascending Dose</intervention_name>
    <description>Subcutaneous Injection: Placebo</description>
    <arm_group_label>Placebo Part A, Single Ascending Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo: Placebo Part B, Multiple Ascending Dose</intervention_name>
    <description>Subcutaneous Injection: Placebo x 5</description>
    <arm_group_label>Placebo Part B, Multiple Ascending Dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or females of any race, between 18 and 60 years of age, inclusive.&#xD;
&#xD;
          -  Body mass index between 18.0 and 28.0 kg/m², inclusive.&#xD;
&#xD;
          -  In good health, determined by no clinically significant findings from medical history,&#xD;
             physical examination, single 12-lead electrocardiogram (resting heart rate &gt; 45 bpm&#xD;
             and &lt; 90 bpm), vital signs measurements, and clinical laboratory evaluations&#xD;
             (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based&#xD;
             on total and direct bilirubin] is not acceptable) at Screening as assessed by the&#xD;
             Investigator (or designee).&#xD;
&#xD;
          -  Willing to abide by the contraception requirements.&#xD;
&#xD;
          -  Able to comprehend and willing to sign an Informed Consent Form and to abide by the&#xD;
             study restrictions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant history or clinical manifestation of any metabolic, allergic,&#xD;
             dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,&#xD;
             gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as&#xD;
             determined by the Investigator (or designee).&#xD;
&#xD;
          -  History of significant hypersensitivity, intolerance, or allergy to any drug compound,&#xD;
             food, or other substance, unless approved by the Investigator (or designee).&#xD;
&#xD;
          -  Any of the following:&#xD;
&#xD;
               -  QT interval corrected for heart rate using Fridericia's method &gt; 450 ms confirmed&#xD;
                  by repeat measurement.&#xD;
&#xD;
               -  QRS duration &gt; 110 ms confirmed by repeat measurement.&#xD;
&#xD;
               -  PR interval &gt; 220 ms confirmed by repeat measurement.&#xD;
&#xD;
               -  findings which would make QT interval corrected for heart rate measurements&#xD;
                  difficult or QT interval corrected for heart rate data uninterpretable.&#xD;
&#xD;
               -  history of additional risk factors for torsades de pointes (eg, heart failure,&#xD;
                  hypokalemia, family history of long QT syndrome).&#xD;
&#xD;
          -  Female subjects who are pregnant or breastfeeding.&#xD;
&#xD;
          -  History of alcoholism or drug/chemical abuse within 1 year prior to Screening.&#xD;
&#xD;
          -  Alcohol consumption of &gt; 21 units per week for males and &gt;14 units per week for&#xD;
             females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL)&#xD;
             of wine, or 1/6 gill (25 mL) of spirits.&#xD;
&#xD;
          -  Positive alcohol breath test result or positive urine drug screen (confirmed by&#xD;
             repeat) at Screening or Check-in.&#xD;
&#xD;
          -  Positive hepatitis panel and/or positive human immunodeficiency virus test.&#xD;
&#xD;
          -  Active skin conditions such as dermatitis, allergy, eczema, psoriasis, or abnormal&#xD;
             healing.&#xD;
&#xD;
          -  Tattoos, scars, or moles that in the opinion of the Investigator are likely to&#xD;
             interfere with dosing or study assessments at any of the potential injection sites.&#xD;
&#xD;
          -  Participation in a clinical study involving administration of an investigational drug&#xD;
             (new chemical entity) in the past 90 days or 5 half-lives of the investigational&#xD;
             product, whichever is longer, prior to Check-in.&#xD;
&#xD;
          -  Use or intend to use any medications/products known to alter drug absorption,&#xD;
             metabolism, or elimination processes, including St. John's wort, within 30 days prior&#xD;
             to Check-in, unless deemed acceptable by the Investigator (or designee).&#xD;
&#xD;
          -  Use or intend to use any prescription medications/products other than hormone&#xD;
             replacement therapy, oral, implantable, transdermal, injectable, or intrauterine&#xD;
             contraceptive concomitant medications within 14 days prior to Check-in, unless deemed&#xD;
             acceptable by the Investigator (or designee).&#xD;
&#xD;
          -  Use or intend to use slow-release medications/products considered to still be active&#xD;
             within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or&#xD;
             designee).&#xD;
&#xD;
          -  Use or intend to use any nonprescription medications/products including vitamins,&#xD;
             minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior&#xD;
             to Check-in, unless deemed acceptable by the Investigator (or designee) and/or Sponsor&#xD;
             have given their prior consent.&#xD;
&#xD;
          -  Use of tobacco- or nicotine-containing products within 3 months prior to Check-in.&#xD;
&#xD;
          -  Receipt of blood products within 60 days prior to Check-in.&#xD;
&#xD;
          -  Donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to&#xD;
             Screening, or platelets from 6 weeks prior to Screening.&#xD;
&#xD;
          -  Poor peripheral venous access.&#xD;
&#xD;
          -  Have previously completed or withdrawn from this study or any other study&#xD;
             investigating OLP-1002, and have previously received the investigational product.&#xD;
&#xD;
          -  Subjects who, in the opinion of the Investigator (or designee), should not participate&#xD;
             in this study.&#xD;
&#xD;
          -  Part A - PD assessment groups only&#xD;
&#xD;
               -  Subjects considered non-acceptable responders to the intradermal capsaicin test&#xD;
                  at screening, defined as maximum VAS score of &lt; 3.0 or &gt; 9.0.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Firas Almazedi, MBChB, MSc, CPI, DipPharmMed</last_name>
    <role>Principal Investigator</role>
    <affiliation>Covance CRU Leeds</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Leeds CRU</name>
      <address>
        <city>Leeds</city>
        <zip>LS2 9LH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <results_first_submitted>June 28, 2021</results_first_submitted>
  <results_first_submitted_qc>August 2, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 26, 2021</results_first_posted>
  <last_update_submitted>August 2, 2021</last_update_submitted>
  <last_update_submitted_qc>August 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pain</keyword>
  <keyword>Pain Injection</keyword>
  <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>September 27, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03760913/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>October 10, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03760913/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo Part A, Single Ascending Dose</title>
          <description>Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo</description>
        </group>
        <group group_id="P2">
          <title>30 ng OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng</description>
        </group>
        <group group_id="P3">
          <title>120 ng OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng</description>
        </group>
        <group group_id="P4">
          <title>400 ng OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng</description>
        </group>
        <group group_id="P5">
          <title>1.2 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg</description>
        </group>
        <group group_id="P6">
          <title>3 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg</description>
        </group>
        <group group_id="P7">
          <title>6 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg</description>
        </group>
        <group group_id="P8">
          <title>12 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg</description>
        </group>
        <group group_id="P9">
          <title>20 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg</description>
        </group>
        <group group_id="P10">
          <title>40 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg</description>
        </group>
        <group group_id="P11">
          <title>80 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg</description>
        </group>
        <group group_id="P12">
          <title>160 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg</description>
        </group>
        <group group_id="P13">
          <title>5 x Placebo Part B, Multiple Ascending Dose</title>
          <description>Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5</description>
        </group>
        <group group_id="P14">
          <title>5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose</title>
          <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg</description>
        </group>
        <group group_id="P15">
          <title>5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose</title>
          <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg</description>
        </group>
        <group group_id="P16">
          <title>5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose</title>
          <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg</description>
        </group>
        <group group_id="P17">
          <title>5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose</title>
          <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg</description>
        </group>
        <group group_id="P18">
          <title>5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose</title>
          <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg</description>
        </group>
        <group group_id="P19">
          <title>5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose</title>
          <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="3"/>
                <participants group_id="P9" count="3"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="6"/>
                <participants group_id="P12" count="6"/>
                <participants group_id="P13" count="12"/>
                <participants group_id="P14" count="6"/>
                <participants group_id="P15" count="6"/>
                <participants group_id="P16" count="6"/>
                <participants group_id="P17" count="6"/>
                <participants group_id="P18" count="6"/>
                <participants group_id="P19" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="3"/>
                <participants group_id="P9" count="3"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="6"/>
                <participants group_id="P12" count="6"/>
                <participants group_id="P13" count="12"/>
                <participants group_id="P14" count="6"/>
                <participants group_id="P15" count="6"/>
                <participants group_id="P16" count="6"/>
                <participants group_id="P17" count="6"/>
                <participants group_id="P18" count="6"/>
                <participants group_id="P19" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo Part A, Single Ascending Dose</title>
          <description>Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo</description>
        </group>
        <group group_id="B2">
          <title>30 ng OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng</description>
        </group>
        <group group_id="B3">
          <title>120 ng OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng</description>
        </group>
        <group group_id="B4">
          <title>400 ng OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng</description>
        </group>
        <group group_id="B5">
          <title>1.2 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg</description>
        </group>
        <group group_id="B6">
          <title>3 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg</description>
        </group>
        <group group_id="B7">
          <title>6 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg</description>
        </group>
        <group group_id="B8">
          <title>12 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg</description>
        </group>
        <group group_id="B9">
          <title>20 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg</description>
        </group>
        <group group_id="B10">
          <title>40 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg</description>
        </group>
        <group group_id="B11">
          <title>80 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg</description>
        </group>
        <group group_id="B12">
          <title>160 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg</description>
        </group>
        <group group_id="B13">
          <title>5 x Placebo Part B, Multiple Ascending Dose</title>
          <description>Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5</description>
        </group>
        <group group_id="B14">
          <title>5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose</title>
          <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg</description>
        </group>
        <group group_id="B15">
          <title>5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose</title>
          <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg</description>
        </group>
        <group group_id="B16">
          <title>5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose</title>
          <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg</description>
        </group>
        <group group_id="B17">
          <title>5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose</title>
          <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg</description>
        </group>
        <group group_id="B18">
          <title>5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose</title>
          <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg</description>
        </group>
        <group group_id="B19">
          <title>5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose</title>
          <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg</description>
        </group>
        <group group_id="B20">
          <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="17"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="3"/>
            <count group_id="B5" value="6"/>
            <count group_id="B6" value="3"/>
            <count group_id="B7" value="6"/>
            <count group_id="B8" value="3"/>
            <count group_id="B9" value="3"/>
            <count group_id="B10" value="6"/>
            <count group_id="B11" value="6"/>
            <count group_id="B12" value="6"/>
            <count group_id="B13" value="12"/>
            <count group_id="B14" value="6"/>
            <count group_id="B15" value="6"/>
            <count group_id="B16" value="6"/>
            <count group_id="B17" value="6"/>
            <count group_id="B18" value="6"/>
            <count group_id="B19" value="6"/>
            <count group_id="B20" value="116"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.2" spread="12.25"/>
                    <measurement group_id="B2" value="35.7" spread="11.55"/>
                    <measurement group_id="B3" value="36.3" spread="10.44"/>
                    <measurement group_id="B4" value="37.0" spread="11.27"/>
                    <measurement group_id="B5" value="37.0" spread="14.25"/>
                    <measurement group_id="B6" value="44.0" spread="12.17"/>
                    <measurement group_id="B7" value="33.8" spread="11.97"/>
                    <measurement group_id="B8" value="34.0" spread="2.65"/>
                    <measurement group_id="B9" value="52.3" spread="6.35"/>
                    <measurement group_id="B10" value="43.7" spread="15.25"/>
                    <measurement group_id="B11" value="40.8" spread="11.27"/>
                    <measurement group_id="B12" value="43.5" spread="12.71"/>
                    <measurement group_id="B13" value="39.7" spread="10.75"/>
                    <measurement group_id="B14" value="35.7" spread="13.60"/>
                    <measurement group_id="B15" value="34.8" spread="13.70"/>
                    <measurement group_id="B16" value="41.0" spread="8.72"/>
                    <measurement group_id="B17" value="42.5" spread="11.31"/>
                    <measurement group_id="B18" value="37.3" spread="15.37"/>
                    <measurement group_id="B19" value="33.3" spread="13.92"/>
                    <measurement group_id="B20" value="38.4" spread="11.91"/>
                  </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="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="2"/>
                    <measurement group_id="B12" value="1"/>
                    <measurement group_id="B13" value="4"/>
                    <measurement group_id="B14" value="3"/>
                    <measurement group_id="B15" value="2"/>
                    <measurement group_id="B16" value="3"/>
                    <measurement group_id="B17" value="2"/>
                    <measurement group_id="B18" value="4"/>
                    <measurement group_id="B19" value="1"/>
                    <measurement group_id="B20" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="4"/>
                    <measurement group_id="B11" value="4"/>
                    <measurement group_id="B12" value="5"/>
                    <measurement group_id="B13" value="8"/>
                    <measurement group_id="B14" value="3"/>
                    <measurement group_id="B15" value="4"/>
                    <measurement group_id="B16" value="3"/>
                    <measurement group_id="B17" value="4"/>
                    <measurement group_id="B18" value="2"/>
                    <measurement group_id="B19" value="5"/>
                    <measurement group_id="B20" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="0"/>
                    <measurement group_id="B20" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="3"/>
                    <measurement group_id="B9" value="3"/>
                    <measurement group_id="B10" value="5"/>
                    <measurement group_id="B11" value="6"/>
                    <measurement group_id="B12" value="6"/>
                    <measurement group_id="B13" value="12"/>
                    <measurement group_id="B14" value="6"/>
                    <measurement group_id="B15" value="6"/>
                    <measurement group_id="B16" value="6"/>
                    <measurement group_id="B17" value="6"/>
                    <measurement group_id="B18" value="6"/>
                    <measurement group_id="B19" value="6"/>
                    <measurement group_id="B20" value="115"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="0"/>
                    <measurement group_id="B20" value="0"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="0"/>
                    <measurement group_id="B20" 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="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="1"/>
                    <measurement group_id="B16" value="1"/>
                    <measurement group_id="B17" value="1"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="0"/>
                    <measurement group_id="B20" value="6"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="0"/>
                    <measurement group_id="B20" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="1"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="1"/>
                    <measurement group_id="B14" value="1"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="1"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="0"/>
                    <measurement group_id="B20" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="3"/>
                    <measurement group_id="B10" value="5"/>
                    <measurement group_id="B11" value="5"/>
                    <measurement group_id="B12" value="6"/>
                    <measurement group_id="B13" value="11"/>
                    <measurement group_id="B14" value="4"/>
                    <measurement group_id="B15" value="5"/>
                    <measurement group_id="B16" value="4"/>
                    <measurement group_id="B17" value="5"/>
                    <measurement group_id="B18" value="6"/>
                    <measurement group_id="B19" value="6"/>
                    <measurement group_id="B20" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="1"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="0"/>
                    <measurement group_id="B20" value="3"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="0"/>
                    <measurement group_id="B20" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="175.2" spread="9.00"/>
                    <measurement group_id="B2" value="183.3" spread="12.06"/>
                    <measurement group_id="B3" value="177.3" spread="6.89"/>
                    <measurement group_id="B4" value="177.3" spread="6.51"/>
                    <measurement group_id="B5" value="173.8" spread="8.89"/>
                    <measurement group_id="B6" value="170.0" spread="6.00"/>
                    <measurement group_id="B7" value="174.2" spread="7.99"/>
                    <measurement group_id="B8" value="166.7" spread="3.79"/>
                    <measurement group_id="B9" value="173.0" spread="12.17"/>
                    <measurement group_id="B10" value="172.7" spread="9.31"/>
                    <measurement group_id="B11" value="176.0" spread="15.31"/>
                    <measurement group_id="B12" value="170.0" spread="5.44"/>
                    <measurement group_id="B13" value="177.1" spread="10.59"/>
                    <measurement group_id="B14" value="174.0" spread="12.81"/>
                    <measurement group_id="B15" value="175.3" spread="9.71"/>
                    <measurement group_id="B16" value="167.7" spread="6.65"/>
                    <measurement group_id="B17" value="173.2" spread="6.71"/>
                    <measurement group_id="B18" value="167.7" spread="12.53"/>
                    <measurement group_id="B19" value="176.8" spread="4.31"/>
                    <measurement group_id="B20" value="174.0" spread="9.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75.74" spread="11.677"/>
                    <measurement group_id="B2" value="77.47" spread="20.400"/>
                    <measurement group_id="B3" value="77.32" spread="9.601"/>
                    <measurement group_id="B4" value="75.33" spread="18.230"/>
                    <measurement group_id="B5" value="70.78" spread="8.725"/>
                    <measurement group_id="B6" value="73.80" spread="0.624"/>
                    <measurement group_id="B7" value="73.17" spread="6.910"/>
                    <measurement group_id="B8" value="66.00" spread="4.513"/>
                    <measurement group_id="B9" value="72.53" spread="11.441"/>
                    <measurement group_id="B10" value="72.72" spread="9.353"/>
                    <measurement group_id="B11" value="76.20" spread="15.517"/>
                    <measurement group_id="B12" value="72.23" spread="9.673"/>
                    <measurement group_id="B13" value="77.61" spread="8.632"/>
                    <measurement group_id="B14" value="73.03" spread="14.719"/>
                    <measurement group_id="B15" value="73.03" spread="14.844"/>
                    <measurement group_id="B16" value="64.08" spread="9.853"/>
                    <measurement group_id="B17" value="70.88" spread="9.658"/>
                    <measurement group_id="B18" value="67.02" spread="13.707"/>
                    <measurement group_id="B19" value="75.65" spread="9.408"/>
                    <measurement group_id="B20" value="73.37" spread="11.061"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.54" spread="2.410"/>
                    <measurement group_id="B2" value="22.73" spread="3.585"/>
                    <measurement group_id="B3" value="24.60" spread="2.649"/>
                    <measurement group_id="B4" value="23.73" spread="4.136"/>
                    <measurement group_id="B5" value="23.45" spread="2.421"/>
                    <measurement group_id="B6" value="25.63" spread="2.003"/>
                    <measurement group_id="B7" value="24.10" spread="1.439"/>
                    <measurement group_id="B8" value="23.73" spread="0.551"/>
                    <measurement group_id="B9" value="24.17" spread="2.335"/>
                    <measurement group_id="B10" value="24.43" spread="2.942"/>
                    <measurement group_id="B11" value="24.37" spread="1.279"/>
                    <measurement group_id="B12" value="24.95" spread="2.513"/>
                    <measurement group_id="B13" value="24.73" spread="1.512"/>
                    <measurement group_id="B14" value="23.95" spread="1.925"/>
                    <measurement group_id="B15" value="23.53" spread="2.642"/>
                    <measurement group_id="B16" value="22.70" spread="2.321"/>
                    <measurement group_id="B17" value="23.57" spread="1.941"/>
                    <measurement group_id="B18" value="23.70" spread="2.700"/>
                    <measurement group_id="B19" value="24.18" spread="2.780"/>
                    <measurement group_id="B20" value="24.13" spread="2.240"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events Stratified by Overall and Severity</title>
        <description>Participants were observed for any signs or symptoms of adverse events and asked about their condition by open questioning, such as &quot;How have you been feeling since you were last asked?&quot;, at least once each day while resident at the study site and at each study visit.</description>
        <time_frame>Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Part A, Single Ascending Dose</title>
            <description>Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo</description>
          </group>
          <group group_id="O2">
            <title>30 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng</description>
          </group>
          <group group_id="O3">
            <title>120 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng</description>
          </group>
          <group group_id="O4">
            <title>400 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng</description>
          </group>
          <group group_id="O5">
            <title>1.2 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg</description>
          </group>
          <group group_id="O6">
            <title>3 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg</description>
          </group>
          <group group_id="O7">
            <title>6 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg</description>
          </group>
          <group group_id="O8">
            <title>12 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg</description>
          </group>
          <group group_id="O9">
            <title>20 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg</description>
          </group>
          <group group_id="O10">
            <title>40 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg</description>
          </group>
          <group group_id="O11">
            <title>80 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg</description>
          </group>
          <group group_id="O12">
            <title>160 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg</description>
          </group>
          <group group_id="O13">
            <title>5 x Placebo Part B, Multiple Ascending Dose</title>
            <description>Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5</description>
          </group>
          <group group_id="O14">
            <title>5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg</description>
          </group>
          <group group_id="O15">
            <title>5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg</description>
          </group>
          <group group_id="O16">
            <title>5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg</description>
          </group>
          <group group_id="O17">
            <title>5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg</description>
          </group>
          <group group_id="O18">
            <title>5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg</description>
          </group>
          <group group_id="O19">
            <title>5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events Stratified by Overall and Severity</title>
          <description>Participants were observed for any signs or symptoms of adverse events and asked about their condition by open questioning, such as &quot;How have you been feeling since you were last asked?&quot;, at least once each day while resident at the study site and at each study visit.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="3"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="6"/>
                <count group_id="O12" value="6"/>
                <count group_id="O13" value="12"/>
                <count group_id="O14" value="6"/>
                <count group_id="O15" value="6"/>
                <count group_id="O16" value="6"/>
                <count group_id="O17" value="6"/>
                <count group_id="O18" value="6"/>
                <count group_id="O19" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treatment-emergent adverse events (Overall)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="3"/>
                    <measurement group_id="O11" value="5"/>
                    <measurement group_id="O12" value="3"/>
                    <measurement group_id="O13" value="7"/>
                    <measurement group_id="O14" value="3"/>
                    <measurement group_id="O15" value="4"/>
                    <measurement group_id="O16" value="5"/>
                    <measurement group_id="O17" value="4"/>
                    <measurement group_id="O18" value="6"/>
                    <measurement group_id="O19" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="2"/>
                    <measurement group_id="O11" value="5"/>
                    <measurement group_id="O12" value="3"/>
                    <measurement group_id="O13" value="7"/>
                    <measurement group_id="O14" value="3"/>
                    <measurement group_id="O15" value="4"/>
                    <measurement group_id="O16" value="4"/>
                    <measurement group_id="O17" value="3"/>
                    <measurement group_id="O18" value="6"/>
                    <measurement group_id="O19" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="1"/>
                    <measurement group_id="O11" value="1"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="1"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="1"/>
                    <measurement group_id="O17" value="2"/>
                    <measurement group_id="O18" value="1"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="0"/>
                    <measurement group_id="O18" value="0"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure</title>
        <description>Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in supine diastolic and systolic blood pressure.&#xD;
Participants were supine for at least 5 minutes before blood pressure measurements. Blood pressure was measured in triplicate and the time of measurement are below:&#xD;
Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15&#xD;
No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant supine blood pressure.&#xD;
Supine diastolic blood pressure reference range: 90 to 140 mmHg. Supine systolic blood pressure reference range: 50 to 90 mmHg.</description>
        <time_frame>Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Part A, Single Ascending Dose</title>
            <description>Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo</description>
          </group>
          <group group_id="O2">
            <title>30 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng</description>
          </group>
          <group group_id="O3">
            <title>120 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng</description>
          </group>
          <group group_id="O4">
            <title>400 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng</description>
          </group>
          <group group_id="O5">
            <title>1.2 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg</description>
          </group>
          <group group_id="O6">
            <title>3 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg</description>
          </group>
          <group group_id="O7">
            <title>6 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg</description>
          </group>
          <group group_id="O8">
            <title>12 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg</description>
          </group>
          <group group_id="O9">
            <title>20 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg</description>
          </group>
          <group group_id="O10">
            <title>40 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg</description>
          </group>
          <group group_id="O11">
            <title>80 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg</description>
          </group>
          <group group_id="O12">
            <title>160 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg</description>
          </group>
          <group group_id="O13">
            <title>5 x Placebo Part B, Multiple Ascending Dose</title>
            <description>Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5</description>
          </group>
          <group group_id="O14">
            <title>5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg</description>
          </group>
          <group group_id="O15">
            <title>5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg</description>
          </group>
          <group group_id="O16">
            <title>5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg</description>
          </group>
          <group group_id="O17">
            <title>5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg</description>
          </group>
          <group group_id="O18">
            <title>5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg</description>
          </group>
          <group group_id="O19">
            <title>5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure</title>
          <description>Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in supine diastolic and systolic blood pressure.&#xD;
Participants were supine for at least 5 minutes before blood pressure measurements. Blood pressure was measured in triplicate and the time of measurement are below:&#xD;
Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15&#xD;
No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant supine blood pressure.&#xD;
Supine diastolic blood pressure reference range: 90 to 140 mmHg. Supine systolic blood pressure reference range: 50 to 90 mmHg.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="3"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="6"/>
                <count group_id="O12" value="6"/>
                <count group_id="O13" value="12"/>
                <count group_id="O14" value="6"/>
                <count group_id="O15" value="6"/>
                <count group_id="O16" value="6"/>
                <count group_id="O17" value="6"/>
                <count group_id="O18" value="6"/>
                <count group_id="O19" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Diastolic blood pressure (mmHg)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="0"/>
                    <measurement group_id="O18" value="0"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic blood pressure (mmHg)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="0"/>
                    <measurement group_id="O18" value="0"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate</title>
        <description>Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in supine pulse rate.&#xD;
Participants were supine for at least 5 minutes before pulse rate measurements. Pulse rate was measured in triplicate and the time of measurement are below:&#xD;
Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15&#xD;
No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant supine pulse rate.&#xD;
Reference range: 40 to 100 beats per minute.</description>
        <time_frame>Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Part A, Single Ascending Dose</title>
            <description>Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo</description>
          </group>
          <group group_id="O2">
            <title>30 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng</description>
          </group>
          <group group_id="O3">
            <title>120 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng</description>
          </group>
          <group group_id="O4">
            <title>400 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng</description>
          </group>
          <group group_id="O5">
            <title>1.2 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg</description>
          </group>
          <group group_id="O6">
            <title>3 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg</description>
          </group>
          <group group_id="O7">
            <title>6 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg</description>
          </group>
          <group group_id="O8">
            <title>12 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg</description>
          </group>
          <group group_id="O9">
            <title>20 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg</description>
          </group>
          <group group_id="O10">
            <title>40 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg</description>
          </group>
          <group group_id="O11">
            <title>80 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg</description>
          </group>
          <group group_id="O12">
            <title>160 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg</description>
          </group>
          <group group_id="O13">
            <title>5 x Placebo Part B, Multiple Ascending Dose</title>
            <description>Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5</description>
          </group>
          <group group_id="O14">
            <title>5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg</description>
          </group>
          <group group_id="O15">
            <title>5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg</description>
          </group>
          <group group_id="O16">
            <title>5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg</description>
          </group>
          <group group_id="O17">
            <title>5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg</description>
          </group>
          <group group_id="O18">
            <title>5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg</description>
          </group>
          <group group_id="O19">
            <title>5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate</title>
          <description>Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in supine pulse rate.&#xD;
Participants were supine for at least 5 minutes before pulse rate measurements. Pulse rate was measured in triplicate and the time of measurement are below:&#xD;
Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15&#xD;
No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant supine pulse rate.&#xD;
Reference range: 40 to 100 beats per minute.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="3"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="6"/>
                <count group_id="O12" value="6"/>
                <count group_id="O13" value="12"/>
                <count group_id="O14" value="6"/>
                <count group_id="O15" value="6"/>
                <count group_id="O16" value="6"/>
                <count group_id="O17" value="6"/>
                <count group_id="O18" value="6"/>
                <count group_id="O19" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="0"/>
                    <measurement group_id="O18" value="0"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate</title>
        <description>Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in respiratory rate.&#xD;
Participants were supine for at least 5 minutes before respiratory rate measurements. Respiratory rate was measured in triplicate and the time of measurement are below:&#xD;
Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15&#xD;
No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant respiratory rate.&#xD;
Reference range: 10 to 24 breaths per minute.</description>
        <time_frame>Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Part A, Single Ascending Dose</title>
            <description>Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo</description>
          </group>
          <group group_id="O2">
            <title>30 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng</description>
          </group>
          <group group_id="O3">
            <title>120 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng</description>
          </group>
          <group group_id="O4">
            <title>400 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng</description>
          </group>
          <group group_id="O5">
            <title>1.2 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg</description>
          </group>
          <group group_id="O6">
            <title>3 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg</description>
          </group>
          <group group_id="O7">
            <title>6 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg</description>
          </group>
          <group group_id="O8">
            <title>12 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg</description>
          </group>
          <group group_id="O9">
            <title>20 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg</description>
          </group>
          <group group_id="O10">
            <title>40 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg</description>
          </group>
          <group group_id="O11">
            <title>80 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg</description>
          </group>
          <group group_id="O12">
            <title>160 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg</description>
          </group>
          <group group_id="O13">
            <title>5 x Placebo Part B, Multiple Ascending Dose</title>
            <description>Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5</description>
          </group>
          <group group_id="O14">
            <title>5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg</description>
          </group>
          <group group_id="O15">
            <title>5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg</description>
          </group>
          <group group_id="O16">
            <title>5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg</description>
          </group>
          <group group_id="O17">
            <title>5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg</description>
          </group>
          <group group_id="O18">
            <title>5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg</description>
          </group>
          <group group_id="O19">
            <title>5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate</title>
          <description>Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in respiratory rate.&#xD;
Participants were supine for at least 5 minutes before respiratory rate measurements. Respiratory rate was measured in triplicate and the time of measurement are below:&#xD;
Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15&#xD;
No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant respiratory rate.&#xD;
Reference range: 10 to 24 breaths per minute.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="3"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="6"/>
                <count group_id="O12" value="6"/>
                <count group_id="O13" value="12"/>
                <count group_id="O14" value="6"/>
                <count group_id="O15" value="6"/>
                <count group_id="O16" value="6"/>
                <count group_id="O17" value="6"/>
                <count group_id="O18" value="6"/>
                <count group_id="O19" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="0"/>
                    <measurement group_id="O18" value="0"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>12-lead Electrocardiogram Parameters</title>
        <description>Resting 12-lead electrocardiogram parameters were recorded after the participant had been supine and at rest for at least 5 minutes.&#xD;
Baseline: the last value recorded prior to first dose; QTcB: QT interval corrected for heart rate using Bazett's formula; QTcF: QT interval corrected for heart rate using Fridericia's method.</description>
        <time_frame>Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Part A, Single Ascending Dose</title>
            <description>Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo</description>
          </group>
          <group group_id="O2">
            <title>30 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng</description>
          </group>
          <group group_id="O3">
            <title>120 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng</description>
          </group>
          <group group_id="O4">
            <title>400 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng</description>
          </group>
          <group group_id="O5">
            <title>1.2 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg</description>
          </group>
          <group group_id="O6">
            <title>3 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg</description>
          </group>
          <group group_id="O7">
            <title>6 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg</description>
          </group>
          <group group_id="O8">
            <title>12 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg</description>
          </group>
          <group group_id="O9">
            <title>20 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg</description>
          </group>
          <group group_id="O10">
            <title>40 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg</description>
          </group>
          <group group_id="O11">
            <title>80 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg</description>
          </group>
          <group group_id="O12">
            <title>160 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg</description>
          </group>
          <group group_id="O13">
            <title>5 x Placebo Part B, Multiple Ascending Dose</title>
            <description>Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5</description>
          </group>
          <group group_id="O14">
            <title>5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg</description>
          </group>
          <group group_id="O15">
            <title>5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg</description>
          </group>
          <group group_id="O16">
            <title>5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg</description>
          </group>
          <group group_id="O17">
            <title>5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg</description>
          </group>
          <group group_id="O18">
            <title>5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg</description>
          </group>
          <group group_id="O19">
            <title>5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg</description>
          </group>
        </group_list>
        <measure>
          <title>12-lead Electrocardiogram Parameters</title>
          <description>Resting 12-lead electrocardiogram parameters were recorded after the participant had been supine and at rest for at least 5 minutes.&#xD;
Baseline: the last value recorded prior to first dose; QTcB: QT interval corrected for heart rate using Bazett's formula; QTcF: QT interval corrected for heart rate using Fridericia's method.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="3"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="6"/>
                <count group_id="O12" value="6"/>
                <count group_id="O13" value="12"/>
                <count group_id="O14" value="6"/>
                <count group_id="O15" value="6"/>
                <count group_id="O16" value="6"/>
                <count group_id="O17" value="6"/>
                <count group_id="O18" value="6"/>
                <count group_id="O19" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Maximum postdose QTcB greater than 450 milliseconds</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="1"/>
                    <measurement group_id="O14" value="1"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="0"/>
                    <measurement group_id="O18" value="0"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum increase from baseline in QTcB greater than 30 milliseconds</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="1"/>
                    <measurement group_id="O14" value="1"/>
                    <measurement group_id="O15" value="1"/>
                    <measurement group_id="O16" value="1"/>
                    <measurement group_id="O17" value="3"/>
                    <measurement group_id="O18" value="2"/>
                    <measurement group_id="O19" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum postdose QTcF greater than 450 milliseconds</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="1"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="0"/>
                    <measurement group_id="O18" value="1"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum increase from baseline in QTcF greater than 30 milliseconds</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="1"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="1"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="1"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="2"/>
                    <measurement group_id="O18" value="1"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results</title>
        <description>Number of participants with findings of clinical importance in clinical chemistry, hematology, and urinalysis test results.&#xD;
Clinical laboratory evaluations included:&#xD;
Clinical chemistry: Alanine aminotransferase; Albumin; Alkaline phosphatase; Aspartate aminotransferase; Calcium; Chloride; Cholesterol; Creatinine; Direct bilirubin; Gamma-glutamyl transferase; Glucose; Inorganic phosphate; Potassium; Sodium; Total bilirubin; Total protein; Urea Hematology: Hematocrit; Hemoglobin; Mean cell hemoglobin; Mean cell hemoglobin concentration; Mean cell volume; Platelet count; Red blood cell count; White blood cell count; White blood cell differential (Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils) Urinalysis: Blood; Glucose; Ketones; pH; Protein; Specific gravity; Urobilinogen; Microscopic examination</description>
        <time_frame>Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Part A, Single Ascending Dose</title>
            <description>Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo</description>
          </group>
          <group group_id="O2">
            <title>30 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng</description>
          </group>
          <group group_id="O3">
            <title>120 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng</description>
          </group>
          <group group_id="O4">
            <title>400 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng</description>
          </group>
          <group group_id="O5">
            <title>1.2 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg</description>
          </group>
          <group group_id="O6">
            <title>3 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg</description>
          </group>
          <group group_id="O7">
            <title>6 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg</description>
          </group>
          <group group_id="O8">
            <title>12 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg</description>
          </group>
          <group group_id="O9">
            <title>20 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg</description>
          </group>
          <group group_id="O10">
            <title>40 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg</description>
          </group>
          <group group_id="O11">
            <title>80 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg</description>
          </group>
          <group group_id="O12">
            <title>160 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg</description>
          </group>
          <group group_id="O13">
            <title>5 x Placebo Part B, Multiple Ascending Dose</title>
            <description>Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5</description>
          </group>
          <group group_id="O14">
            <title>5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg</description>
          </group>
          <group group_id="O15">
            <title>5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg</description>
          </group>
          <group group_id="O16">
            <title>5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg</description>
          </group>
          <group group_id="O17">
            <title>5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg</description>
          </group>
          <group group_id="O18">
            <title>5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg</description>
          </group>
          <group group_id="O19">
            <title>5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results</title>
          <description>Number of participants with findings of clinical importance in clinical chemistry, hematology, and urinalysis test results.&#xD;
Clinical laboratory evaluations included:&#xD;
Clinical chemistry: Alanine aminotransferase; Albumin; Alkaline phosphatase; Aspartate aminotransferase; Calcium; Chloride; Cholesterol; Creatinine; Direct bilirubin; Gamma-glutamyl transferase; Glucose; Inorganic phosphate; Potassium; Sodium; Total bilirubin; Total protein; Urea Hematology: Hematocrit; Hemoglobin; Mean cell hemoglobin; Mean cell hemoglobin concentration; Mean cell volume; Platelet count; Red blood cell count; White blood cell count; White blood cell differential (Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils) Urinalysis: Blood; Glucose; Ketones; pH; Protein; Specific gravity; Urobilinogen; Microscopic examination</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="3"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="6"/>
                <count group_id="O12" value="6"/>
                <count group_id="O13" value="12"/>
                <count group_id="O14" value="6"/>
                <count group_id="O15" value="6"/>
                <count group_id="O16" value="6"/>
                <count group_id="O17" value="6"/>
                <count group_id="O18" value="6"/>
                <count group_id="O19" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="0"/>
                    <measurement group_id="O18" value="0"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Full and Symptom-Directed Physical Examination Results</title>
        <description>A full physical examination and symptom-directed physical examinations were performed at specified timepoints.</description>
        <time_frame>Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Part A, Single Ascending Dose</title>
            <description>Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo</description>
          </group>
          <group group_id="O2">
            <title>30 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng</description>
          </group>
          <group group_id="O3">
            <title>120 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng</description>
          </group>
          <group group_id="O4">
            <title>400 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng</description>
          </group>
          <group group_id="O5">
            <title>1.2 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg</description>
          </group>
          <group group_id="O6">
            <title>3 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg</description>
          </group>
          <group group_id="O7">
            <title>6 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg</description>
          </group>
          <group group_id="O8">
            <title>12 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg</description>
          </group>
          <group group_id="O9">
            <title>20 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg</description>
          </group>
          <group group_id="O10">
            <title>40 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg</description>
          </group>
          <group group_id="O11">
            <title>80 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg</description>
          </group>
          <group group_id="O12">
            <title>160 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg</description>
          </group>
          <group group_id="O13">
            <title>5 x Placebo Part B, Multiple Ascending Dose</title>
            <description>Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5</description>
          </group>
          <group group_id="O14">
            <title>5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg</description>
          </group>
          <group group_id="O15">
            <title>5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg</description>
          </group>
          <group group_id="O16">
            <title>5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg</description>
          </group>
          <group group_id="O17">
            <title>5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg</description>
          </group>
          <group group_id="O18">
            <title>5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg</description>
          </group>
          <group group_id="O19">
            <title>5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Full and Symptom-Directed Physical Examination Results</title>
          <description>A full physical examination and symptom-directed physical examinations were performed at specified timepoints.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="3"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="6"/>
                <count group_id="O12" value="6"/>
                <count group_id="O13" value="12"/>
                <count group_id="O14" value="6"/>
                <count group_id="O15" value="6"/>
                <count group_id="O16" value="6"/>
                <count group_id="O17" value="6"/>
                <count group_id="O18" value="6"/>
                <count group_id="O19" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Medical device site rash (clinically significant, not related to study drug)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="0"/>
                    <measurement group_id="O18" value="0"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sunburn (clinically significant, not related to study drug)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="0"/>
                    <measurement group_id="O18" value="0"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Papule (clinically significant, not related to study drug)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="1"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="0"/>
                    <measurement group_id="O18" value="0"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tongue ulceration (clinically significant, not related to study drug)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="1"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="0"/>
                    <measurement group_id="O18" value="0"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gingival swelling (clinically significant, not related to study drug)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="1"/>
                    <measurement group_id="O17" value="0"/>
                    <measurement group_id="O18" value="0"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Injection Site Assessment Results</title>
        <description>Evaluation of the dosing site for the following:&#xD;
Pain: Grade 0 to 4 Redness (assessed by estimating the size of the red patch at the injection site across its widest point): Grade 0: 0-24 mm; Grade 1: 25-50 mm; Grade 2: 51-100 mm; Grade 3: More than 100 mm; Grade 4: Requires medical intervention greater than analgesia Swelling (assessed by estimating the size of the raised area around the injection site across its widest point): Grade 0: 0-24 mm; Grade 1: 25-50 mm and does not interfere with activity; Grade 2: 51-100 mm or interferes with activity; Grade 3: More than 100 mm and prevents daily activity; Grade 4: Requires medical intervention greater than analgesia Tenderness: Grade 0 to 4&#xD;
Bruising and ulceration were evaluated as present or absent.</description>
        <time_frame>Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Part A, Single Ascending Dose</title>
            <description>Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo</description>
          </group>
          <group group_id="O2">
            <title>30 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng</description>
          </group>
          <group group_id="O3">
            <title>120 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng</description>
          </group>
          <group group_id="O4">
            <title>400 ng OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng</description>
          </group>
          <group group_id="O5">
            <title>1.2 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg</description>
          </group>
          <group group_id="O6">
            <title>3 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg</description>
          </group>
          <group group_id="O7">
            <title>6 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg</description>
          </group>
          <group group_id="O8">
            <title>12 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg</description>
          </group>
          <group group_id="O9">
            <title>20 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg</description>
          </group>
          <group group_id="O10">
            <title>40 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg</description>
          </group>
          <group group_id="O11">
            <title>80 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg</description>
          </group>
          <group group_id="O12">
            <title>160 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg</description>
          </group>
          <group group_id="O13">
            <title>5 x Placebo Part B, Multiple Ascending Dose</title>
            <description>Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5</description>
          </group>
          <group group_id="O14">
            <title>5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg</description>
          </group>
          <group group_id="O15">
            <title>5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg</description>
          </group>
          <group group_id="O16">
            <title>5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg</description>
          </group>
          <group group_id="O17">
            <title>5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg</description>
          </group>
          <group group_id="O18">
            <title>5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg</description>
          </group>
          <group group_id="O19">
            <title>5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Injection Site Assessment Results</title>
          <description>Evaluation of the dosing site for the following:&#xD;
Pain: Grade 0 to 4 Redness (assessed by estimating the size of the red patch at the injection site across its widest point): Grade 0: 0-24 mm; Grade 1: 25-50 mm; Grade 2: 51-100 mm; Grade 3: More than 100 mm; Grade 4: Requires medical intervention greater than analgesia Swelling (assessed by estimating the size of the raised area around the injection site across its widest point): Grade 0: 0-24 mm; Grade 1: 25-50 mm and does not interfere with activity; Grade 2: 51-100 mm or interferes with activity; Grade 3: More than 100 mm and prevents daily activity; Grade 4: Requires medical intervention greater than analgesia Tenderness: Grade 0 to 4&#xD;
Bruising and ulceration were evaluated as present or absent.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="3"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="6"/>
                <count group_id="O12" value="6"/>
                <count group_id="O13" value="12"/>
                <count group_id="O14" value="6"/>
                <count group_id="O15" value="6"/>
                <count group_id="O16" value="6"/>
                <count group_id="O17" value="6"/>
                <count group_id="O18" value="6"/>
                <count group_id="O19" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain : Grade 1 (does not interfere with activity)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="1"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="0"/>
                    <measurement group_id="O18" value="1"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain : Grade 2 (interferes with activity or repeated use of non-narcotic pain reliever)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="0"/>
                    <measurement group_id="O18" value="0"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tenderness : Grade 1 (mild pain to touch)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="1"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="2"/>
                    <measurement group_id="O12" value="1"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="1"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="0"/>
                    <measurement group_id="O18" value="1"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tenderness : Grade 2 (moderate pain to touch)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="1"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="0"/>
                    <measurement group_id="O18" value="0"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness : Grade 1 (25-50 mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="1"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="0"/>
                    <measurement group_id="O18" value="0"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness : Grade 2 (51-100 mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="0"/>
                    <measurement group_id="O18" value="0"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling : Grade 1 (25-50 mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="1"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="0"/>
                    <measurement group_id="O18" value="0"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling : Grade 2 (51-100 mm or interferes with activity)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="0"/>
                    <measurement group_id="O18" value="0"/>
                    <measurement group_id="O19" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bruising : Present</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="1"/>
                    <measurement group_id="O10" value="1"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="1"/>
                    <measurement group_id="O15" value="3"/>
                    <measurement group_id="O16" value="1"/>
                    <measurement group_id="O17" value="0"/>
                    <measurement group_id="O18" value="3"/>
                    <measurement group_id="O19" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies</title>
        <description>Participants were assessed to demonstrate that exposure to OLP-1002 did not exceed pre-defined exposure limits from non-clinical studies. Participants with temporary detected plasma concentrations between the low limit of detection [0.2 ng/mL] and lower limit of quantification [1 ng/mL] are presented in the results.</description>
        <time_frame>Part A: Day 1 postdose. Part B: Day 1 postdose and Day 13 postdose.</time_frame>
        <population>Safety Population.&#xD;
Plasma concentrations of OLP-1002 were not analyzed for the groups receiving single doses of 30 ng, 120 ng, 400 ng, 1.2 µg, and 3 µg OLP-1002 and were assumed also to be below the lower limit of quantification/limit of detection. Day 13 assessments were not applicable for Part A of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>12 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg</description>
          </group>
          <group group_id="O2">
            <title>20 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg</description>
          </group>
          <group group_id="O3">
            <title>40 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg</description>
          </group>
          <group group_id="O4">
            <title>80 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg</description>
          </group>
          <group group_id="O5">
            <title>160 µg OLP-1002: Part A, Single Ascending Dose</title>
            <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg</description>
          </group>
          <group group_id="O6">
            <title>5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg</description>
          </group>
          <group group_id="O7">
            <title>5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg</description>
          </group>
          <group group_id="O8">
            <title>5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg</description>
          </group>
          <group group_id="O9">
            <title>5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg</description>
          </group>
          <group group_id="O10">
            <title>5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg</description>
          </group>
          <group group_id="O11">
            <title>5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose</title>
            <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies</title>
          <description>Participants were assessed to demonstrate that exposure to OLP-1002 did not exceed pre-defined exposure limits from non-clinical studies. Participants with temporary detected plasma concentrations between the low limit of detection [0.2 ng/mL] and lower limit of quantification [1 ng/mL] are presented in the results.</description>
          <population>Safety Population.&#xD;
Plasma concentrations of OLP-1002 were not analyzed for the groups receiving single doses of 30 ng, 120 ng, 400 ng, 1.2 µg, and 3 µg OLP-1002 and were assumed also to be below the lower limit of quantification/limit of detection. Day 13 assessments were not applicable for Part A of the study.</population>
          <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 group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 Postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="3"/>
                    <measurement group_id="O11" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13 Postdose</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 group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                    <count group_id="O9" value="6"/>
                    <count group_id="O10" value="6"/>
                    <count group_id="O11" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="3"/>
                    <measurement group_id="O11" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Part A: From Screening until Poststudy (Day 28 ±2 days); Part B: From Screening until Poststudy (Day 57 ±2 days)</time_frame>
      <desc>The condition of each participant was monitored from the time of signing informed consent form to final discharge from the study. Participants were observed for any signs or symptoms and asked about their condition by open questioning, such as &quot;How have you been feeling since you were last asked?&quot;, at least once each day while resident at the study site and at each study visit. Participants were also encouraged to spontaneously report adverse events occurring at any other time during the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo Part A, Single Ascending Dose</title>
          <description>Placebo: Part A, Single Ascending Dose: Subcutaneous Injection: Placebo</description>
        </group>
        <group group_id="E2">
          <title>30 ng OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 30 ng</description>
        </group>
        <group group_id="E3">
          <title>120 ng OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 120 ng</description>
        </group>
        <group group_id="E4">
          <title>400 ng OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 400 ng</description>
        </group>
        <group group_id="E5">
          <title>1.2 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 1.2 µg</description>
        </group>
        <group group_id="E6">
          <title>3 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 3 µg</description>
        </group>
        <group group_id="E7">
          <title>6 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 6 µg</description>
        </group>
        <group group_id="E8">
          <title>12 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 12 µg</description>
        </group>
        <group group_id="E9">
          <title>20 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 20 µg</description>
        </group>
        <group group_id="E10">
          <title>40 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 40 µg</description>
        </group>
        <group group_id="E11">
          <title>80 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 80 µg</description>
        </group>
        <group group_id="E12">
          <title>160 µg OLP-1002: Part A, Single Ascending Dose</title>
          <description>OLP-1002 (Test): Part A, Single Ascending Dose: Subcutaneous Injection: 160 µg</description>
        </group>
        <group group_id="E13">
          <title>5 x Placebo Part B, Multiple Ascending Dose</title>
          <description>Placebo: Part B, Multiple Ascending Dose: Subcutaneous Injection: Placebo x 5</description>
        </group>
        <group group_id="E14">
          <title>5 x 2 μg OLP-1002: Part B, Multiple Ascending Dose</title>
          <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 2 μg</description>
        </group>
        <group group_id="E15">
          <title>5 x 5 μg OLP-1002: Part B, Multiple Ascending Dose</title>
          <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 5 μg</description>
        </group>
        <group group_id="E16">
          <title>5 x 10 μg OLP-1002: Part B, Multiple Ascending Dose</title>
          <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 10 μg</description>
        </group>
        <group group_id="E17">
          <title>5 x 20 μg OLP-1002: Part B, Multiple Ascending Dose</title>
          <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 20 μg</description>
        </group>
        <group group_id="E18">
          <title>5 x 40 μg OLP-1002: Part B, Multiple Ascending Dose</title>
          <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 40 μg</description>
        </group>
        <group group_id="E19">
          <title>5 x 80 μg OLP-1002: Part B, Multiple Ascending Dose</title>
          <description>OLP-1002 (Test): Part B, Multiple Ascending Dose: Subcutaneous Injection: 5 x 80 μg</description>
        </group>
      </group_list>
      <serious_events>
        <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="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (22.1)</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="7" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="7" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="5" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Gingival swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Tongue ulceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Medical device site rash</sub_title>
                <description>General disorders and administration site conditions</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <description>General disorders and administration site conditions</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Infusion site erythema</sub_title>
                <description>General disorders and administration site conditions</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Medical device site erythema</sub_title>
                <description>General disorders and administration site conditions</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Medical device site irritation</sub_title>
                <description>General disorders and administration site conditions</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Medical device site pruritus</sub_title>
                <description>General disorders and administration site conditions</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Vessel puncture site pain</sub_title>
                <description>General disorders and administration site conditions</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <description>General disorders and administration site conditions</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <description>General disorders and administration site conditions</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Injection site paraesthesia</sub_title>
                <description>General disorders and administration site conditions</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <description>General disorders and administration site conditions</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <description>General disorders and administration site conditions</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Thirst</sub_title>
                <description>General disorders and administration site conditions</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Sunburn</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Head discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Poor quality sleep</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abnormal dreams</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Papule</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Rash papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="6"/>
              </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>The Principal Investigator shall not use the name, trademark or the name of any representative of the other, or the existence of their agreement with the sponsor for any promotional or advertising purposes, or any other publication, without the prior written consent of the sponsor, or state or imply that the sponsor endorses or approves any service, material, product or compound of the sponsor without the prior written consent of the sponsor.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>OliPass Call Center</name_or_title>
      <organization>OliPass Corporation</organization>
      <phone>82-2-6488-2200</phone>
      <email>clinicaltrials.inquiries@olipass.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/NCT03760913
org study id: OLP-1002-001
nct id: NCT03760913
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary objective of the study is to assess the safety and tolerability of single and
      multiple subcutaneous doses of OLP-1002 in healthy subjects.
The exploratory objectives of the study are to evaluate the pharmacodynamic effect of
      OLP-1002 following single subcutaneous doses in healthy volunteers using a capsaicin pain
      model, and to monitor the effects of a single subcutaneous doses of OLP-1002 on cardiac QT
      interval. Where possible, single and/or multiple subcutaneous dose pharmacokinetics of
      OLP-1002 in healthy subjects will be determined.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This will be a double-blind, randomized, placebo-controlled, single and multiple subcutaneous dose study.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: double-blind
measure: Number of Participants With Adverse Events Stratified by Overall and Severity
time frame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
description: Participants were observed for any signs or symptoms of adverse events and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit.
measure: Number of Participants Who Experienced Clinically Important Changes in Supine Diastolic and Systolic Blood Pressure
time frame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
description: Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in supine diastolic and systolic blood pressure.
Participants were supine for at least 5 minutes before blood pressure measurements. Blood pressure was measured in triplicate and the time of measurement are below:
Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15
No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant supine blood pressure.
Supine diastolic blood pressure reference range: 90 to 140 mmHg. Supine systolic blood pressure reference range: 50 to 90 mmHg.
measure: Number of Participants Who Experienced Clinically Important Changes in Supine Pulse Rate
time frame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
description: Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in supine pulse rate.
Participants were supine for at least 5 minutes before pulse rate measurements. Pulse rate was measured in triplicate and the time of measurement are below:
Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15
No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant supine pulse rate.
Reference range: 40 to 100 beats per minute.
measure: Number of Participants Who Experienced Clinically Important Changes in Respiratory Rate
time frame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
description: Number of participants who experienced clinically important changes from baseline (the last value recorded prior to first dose) to scheduled timepoints in respiratory rate.
Participants were supine for at least 5 minutes before respiratory rate measurements. Respiratory rate was measured in triplicate and the time of measurement are below:
Single ascending dose: Predose, 1, 2, 4, 8, 24 (± 1 hours), and 48 hours posdose Multiple ascending dose: Day 1 (Predose, 1, 2, 4, and 8 hours postdose), Day 2, Day 4 (postdose), Day 5, Day 7 (postdose), Day 9, Day 10 (postdose), Day 12, Day 13 (predose, 1, 2, 4, and 8 hours postdose), and Day 15
No treatment or dose related trends and no clinically significant changes were observed in mean or individual participant respiratory rate.
Reference range: 10 to 24 breaths per minute.
measure: 12-lead Electrocardiogram Parameters
time frame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
description: Resting 12-lead electrocardiogram parameters were recorded after the participant had been supine and at rest for at least 5 minutes.
Baseline: the last value recorded prior to first dose; QTcB: QT interval corrected for heart rate using Bazett's formula; QTcF: QT interval corrected for heart rate using Fridericia's method.
measure: Number of Participants With Findings of Clinical Importance in Clinical Chemistry, Hematology, and Urinalysis Test Results
time frame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
description: Number of participants with findings of clinical importance in clinical chemistry, hematology, and urinalysis test results.
Clinical laboratory evaluations included:
Clinical chemistry: Alanine aminotransferase; Albumin; Alkaline phosphatase; Aspartate aminotransferase; Calcium; Chloride; Cholesterol; Creatinine; Direct bilirubin; Gamma-glutamyl transferase; Glucose; Inorganic phosphate; Potassium; Sodium; Total bilirubin; Total protein; Urea Hematology: Hematocrit; Hemoglobin; Mean cell hemoglobin; Mean cell hemoglobin concentration; Mean cell volume; Platelet count; Red blood cell count; White blood cell count; White blood cell differential (Basophils; Eosinophils; Lymphocytes; Monocytes; Neutrophils) Urinalysis: Blood; Glucose; Ketones; pH; Protein; Specific gravity; Urobilinogen; Microscopic examination
measure: Number of Participants With Full and Symptom-Directed Physical Examination Results
time frame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
description: A full physical examination and symptom-directed physical examinations were performed at specified timepoints.
measure: Number of Participants With Injection Site Assessment Results
time frame: Part A: From screening through study completion, up to 32 days. Part B: From screening through study completion, up to 60 days.
description: Evaluation of the dosing site for the following:
Pain: Grade 0 to 4 Redness (assessed by estimating the size of the red patch at the injection site across its widest point): Grade 0: 0-24 mm; Grade 1: 25-50 mm; Grade 2: 51-100 mm; Grade 3: More than 100 mm; Grade 4: Requires medical intervention greater than analgesia Swelling (assessed by estimating the size of the raised area around the injection site across its widest point): Grade 0: 0-24 mm; Grade 1: 25-50 mm and does not interfere with activity; Grade 2: 51-100 mm or interferes with activity; Grade 3: More than 100 mm and prevents daily activity; Grade 4: Requires medical intervention greater than analgesia Tenderness: Grade 0 to 4
Bruising and ulceration were evaluated as present or absent.
measure: Number of Participants With Exposure to OLP-1002 That Exceeded Pre-define Exposure Limits From Non-clinical Studies
time frame: Part A: Day 1 postdose. Part B: Day 1 postdose and Day 13 postdose.
description: Participants were assessed to demonstrate that exposure to OLP-1002 did not exceed pre-defined exposure limits from non-clinical studies. Participants with temporary detected plasma concentrations between the low limit of detection [0.2 ng/mL] and lower limit of quantification [1 ng/mL] are presented in the results.
arm group label: OLP-1002: Part A, Single Ascending Dose
arm group type: Experimental
description: Subcutaneous Injection: 30 ng, 120 ng, 400 ng, 1.2 μg, 3 μg, 6 μg, 12 μg, 20 μg, 40 μg, 80 μg, 160 μg
arm group label: OLP-1002: Part B, Multiple Ascending Dose
arm group type: Experimental
description: Subcutaneous Injection: 5 x 2 μg, 5 x 5 μg, 5 x 10 μg, 5 x 20 μg, 5 x 40 μg, 5 x 80 μg
arm group label: Placebo Part A, Single Ascending Dose
arm group type: Placebo Comparator
description: Subcutaneous Injection: Placebo
arm group label: Placebo Part B, Multiple Ascending Dose
arm group type: Placebo Comparator
description: Subcutaneous Injection: Placebo x 5
intervention type: Drug
intervention name: OLP-1002 (Test): Part A, Single Ascending Dose
description: Subcutaneous Injection: 30 ng, 120 ng, 400 ng, 1.2 µg, 3 µg, 6 µg, 12 µg, 20 µg, 40 μg, 80 μg, 160 μg
arm group label: OLP-1002: Part A, Single Ascending Dose
intervention type: Drug
intervention name: OLP-1002 (Test): Part B, Multiple Ascending Dose
description: Subcutaneous Injection: 5 x 2 μg, 5 x 5 μg, 5 x 10 μg, 5 x 20 μg, 5 x 40 μg, 5 x 80 μg
arm group label: OLP-1002: Part B, Multiple Ascending Dose
intervention type: Other
intervention name: Placebo: Placebo Part A, Single Ascending Dose
description: Subcutaneous Injection: Placebo
arm group label: Placebo Part A, Single Ascending Dose
intervention type: Other
intervention name: Placebo: Placebo Part B, Multiple Ascending Dose
description: Subcutaneous Injection: Placebo x 5
arm group label: Placebo Part B, Multiple Ascending Dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Firas Almazedi, MBChB, MSc, CPI, DipPharmMed
role: Principal Investigator
affiliation: Covance CRU Leeds
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 