<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/NCT03809663</url>
  </required_header>
  <id_info>
    <org_study_id>20170755</org_study_id>
    <secondary_id>2018-001997-52</secondary_id>
    <nct_id>NCT03809663</nct_id>
  </id_info>
  <brief_title>A Dose Ranging Placebo-Controlled Double-Blind Study to Evaluate the Safety and Efficacy of Tezepelumab in Atopic Dermatitis</brief_title>
  <official_title>A Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Tezepelumab Alone or Combined With Topical Corticosteroids in Moderate-to-Severe Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase 2b study is designed to evaluate the safety and efficacy of tezepelumab as a&#xD;
      monotherapy and explore its efficacy as adjunct therapy in subjects with moderate-to-severe&#xD;
      atopic dermatitis (AD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All subjects will receive a subcutaneous (SC) dose of either investigational product or&#xD;
      placebo as the first dose on day 1.&#xD;
&#xD;
      Subjects who are determined to be non-responders in Part A will receive tezepelumab SC every&#xD;
      2 weeks (Q2W) following completion of all week 16 study activities. Nonresponders are defined&#xD;
      as those subjects who have not achieved at least a 50% improvement in Eczema Area and&#xD;
      Severity Index (EASI) at week 16 compared to baseline (day 1).&#xD;
&#xD;
      Safety follow-up is 18 weeks after the end of treatment (EOT) visit (20 weeks after the final&#xD;
      dose of investigational product).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Tezepelumab as a monotherapy in atopic dermatitis did not reach the targeted efficacy level&#xD;
    pre-established for this patient population.&#xD;
  </why_stopped>
  <start_date type="Actual">March 15, 2019</start_date>
  <completion_date type="Actual">December 22, 2020</completion_date>
  <primary_completion_date type="Actual">May 12, 2020</primary_completion_date>
  <phase>Phase 2</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 phase 2b study is designed to evaluate the safety and efficacy of tezepelumab as a monotherapy and explore its efficacy as adjunct therapy in subjects with moderate-to-severe AD. This study consists of Part A (the main study evaluating tezepelumab as a monotherapy) and Part B (a study evaluating tezepelumab as adjunctive therapy when combined with a topical corticosteroid regimen</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) (IGA 0/1) at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>The IGA allows investigators to assess overall disease severity at 1 given time point and consists of a 6-point severity scale from clear to severe disease&#xD;
0 = clear&#xD;
1 = almost clear&#xD;
2 = mild disease&#xD;
3 = moderate disease&#xD;
4 = severe disease&#xD;
5 = very severe disease&#xD;
The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment (Breuer et al, 2004).&#xD;
Participants who took rescue medication between Day 29 to Week 16 were considered non-responders.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Experienced a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>The EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on key acute and chronic signs of inflammation (ie, erythema, induration/papulation, excoriation, and lichenification).&#xD;
A reduction in the EASI score indicates an improvement in severity. Participants who took rescue medication between Day 29 to Week 16 were considered non-responders.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced a 50% or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI 50/90) at Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>The EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on key acute and chronic signs of inflammation (ie, erythema, induration/papulation, excoriation, and lichenification).&#xD;
A reduction in the EASI score indicates an improvement in severity. Participants who took rescue medication between Day 29 to Week 16 were considered non-responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Achievement of 50%, 75% or 90% Reduction From Day 1 in Eczema Area and Severity Index (EASI 50/75/90)</measure>
    <time_frame>Day 1 up to End of Study Visit (Week 70)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>The SCORAD is a clinical tool for assessing the severity (ie, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with subjective symptoms (Kunz et al, 1997). The total score ranges from 0 to 103, with higher values indicating more severe disease. A negative change from baseline indicates an improvement in severity of disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>Pruritus was assessed using an NRS (0-10) with 0 = no itch and 10 = worst imaginable itch. A negative change from baseline indicates an improvement in symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Trough Concentrations of Tezepelumab After Q2W or Q4W Administration</measure>
    <time_frame>Pre-dose on Day 1, Week 2, 4, 12, 16, 24, 32, 40, 48, 50, 52, 58 and 70</time_frame>
    <description>Switchers were included up to Week 16 and were then excluded from the analysis after switching. All Tezepelumab participants received 420 mg of Tezepelumab on Day 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Trough Concentrations of Tezepelumab After Switching to 420 mg Q2W Administration After Week 16</measure>
    <time_frame>Pre-dose on Week 24, 32, 40, 48, 50, 52, 58 and 70</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">251</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Part A: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo administered via SC injection Q2W for a maximum of 52 weeks.&#xD;
Participants defined as non-responders (those who do not achieve at least 50% improvement in EASI at Week 16 compared to baseline) will switch to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study beginning with the Week 18 dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A: Tezepelumab 210 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.&#xD;
All participants randomized to tezepelumab will receive 420 mg SC injection as their first dose. Participants will then receive a placebo at Week 2 to maintain blinding.&#xD;
Participants defined as non-responders (those who do not achieve at least 50% improvement in EASI at Week 16 compared to baseline) will switch to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study beginning with the Week 18 dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A: Tezepelumab 280 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.&#xD;
All participants randomized to tezepelumab will receive 420 mg SC injection as their first dose. Participants will then receive their randomized dose of 280 mg Q2W from Week 2.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI at Week 16 compared to baseline) will switch to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study beginning with the Week 18 dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A: Tezepelumab 420 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: Placebo and Topical Corticosteroids Regimen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Matching placebo administered via SC injection Q2W with topical corticosteroids (TCS) for a maximum of 52 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: Tezepelumab 420 mg and Topical Corticosteroids Regimen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tezepelumab 420 mg administered via SC injection Q2W with TCS for a maximum of 52 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tezepelumab</intervention_name>
    <description>Solution for injection</description>
    <arm_group_label>Part A: Tezepelumab 210 mg</arm_group_label>
    <arm_group_label>Part A: Tezepelumab 280 mg</arm_group_label>
    <arm_group_label>Part A: Tezepelumab 420 mg</arm_group_label>
    <arm_group_label>Part B: Placebo and Topical Corticosteroids Regimen</arm_group_label>
    <arm_group_label>Part B: Tezepelumab 420 mg and Topical Corticosteroids Regimen</arm_group_label>
    <other_name>AMG157</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo solution for injection</description>
    <arm_group_label>Part A: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has provided informed consent prior to initiation of any study specific&#xD;
             activities/procedures.&#xD;
&#xD;
          -  Age greater than or equal to 18 to less than or equal to 75 years at screening.&#xD;
&#xD;
          -  Clinical diagnosis of chronic AD (also known as atopic eczema) for at least 2 years&#xD;
             prior to screening and has confirmed AD (Hanifin and Rajka criteria for AD (Hanifin&#xD;
             and Rajka, 1980).&#xD;
&#xD;
          -  AD that affects greater than or equal to' 10% body surface area as assessed by EASI at&#xD;
             screening and on day 1.&#xD;
&#xD;
          -  An IGA score of greater than or equal to 3 at screening and on day 1.&#xD;
&#xD;
          -  An EASI score of greater than or equal to 16 at screening and on day 1.&#xD;
&#xD;
          -  Subject discontinued treatment with TCS, topical calcineurin inhibitors (TCI), and&#xD;
             prescription moisturizers containing TCS or topical calcineurin inhibitors (TCI) for&#xD;
             at least the 7 days immediately prior to the first dose of investigational product&#xD;
&#xD;
          -  Documented recent history (within 12 months before the screening visit) of inadequate&#xD;
             response totreatment with topical TCS or subjects for whom topical treatments are&#xD;
             otherwise medically inadvisable (ie, because of important side effects or safety&#xD;
             risks).&#xD;
&#xD;
               -  Inadequate response is defined as failure to achieve and maintain remission or a&#xD;
                  low disease activity state (comparable to IGA 0 = clear to IGA 2 = mild) despite&#xD;
                  treatment with a daily regimen of TCS of medium or higher potency (with or&#xD;
                  without TCI as appropriate).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active dermatologic conditions, which might confound the diagnosis of AD or would&#xD;
             interfere with the assessment of treatment, such as scabies, seborrheic dermatitis,&#xD;
             cutaneous lymphoma, ichthyosis, psoriasis, allergic contact dermatitis, or irritant&#xD;
             contact dermatitis.&#xD;
&#xD;
          -  History of a clinically significant infection within 28 days prior to day 1 that, in&#xD;
             the opinion of the investigator or medical monitor, might compromise the safety of the&#xD;
             subject in the study, interfere with evaluation of the investigational product, or&#xD;
             reduce the subject's ability to participate in the study. Clinically significant&#xD;
             infections are defined as either of the following: 1) a systemic infection; or 2) a&#xD;
             serious skin infection requiring parenteral antibiotic, antiviral, or antifungal&#xD;
             medication.&#xD;
&#xD;
          -  Diagnosis of a helminth parasitic infection within 6 months prior to screening that&#xD;
             had not been treated with or had failed to respond to standard of care therapy.&#xD;
&#xD;
          -  Documented medical history of chronic alcohol or drug abuse within 12 months prior to&#xD;
             screening.&#xD;
&#xD;
          -  History of anaphylaxis following any biologic therapy.&#xD;
&#xD;
          -  Evidence of active liver disease at screening, including jaundice or aspartate&#xD;
             aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase&#xD;
             greater than twice the upper limit of normal (ULN).&#xD;
&#xD;
          -  Subjects who, in the opinion of the investigator, have evidence of active tuberculosis&#xD;
             (TB), either treated or untreated, or a positive QuantiFERON-tuberculosis Gold (QFT-G)&#xD;
             test for TB during screening. Subjects with an indeterminate QFT-G may be enrolled if&#xD;
             they have ALL of the following:&#xD;
&#xD;
               -  No symptoms of TB: productive, prolonged cough (&gt; 3 weeks); coughing up blood;&#xD;
                  fever; night sweats; unexplained appetite loss; unintentional weight loss&#xD;
&#xD;
               -  No evidence of active TB on chest radiograph within 3 months prior to the first&#xD;
                  dose of investigational product. Note: Chest radiograph is not part of screening&#xD;
                  procedure and will be the responsibility&#xD;
&#xD;
          -  Positive hepatitis B surface antigen or hepatitis C antibody serology. Subjects with a&#xD;
             history of hepatitis B vaccination without a history of hepatitis B are allowed to&#xD;
             enroll in the study.&#xD;
&#xD;
          -  Positive human immunodeficiency virus (HIV) test at screening or the subject is taking&#xD;
             antiretroviral medications, as determined by medical history, prior medications,&#xD;
             and/or the subject's verbal report.&#xD;
&#xD;
          -  Other Medical Conditions&gt;&#xD;
&#xD;
          -  History of malignancy, except for basal cell carcinoma or in situ carcinoma of the&#xD;
             cervix treated with apparent success with curative therapy ≥ 12 months prior to&#xD;
             screening or other malignancies treated with apparent success with curative therapy ≥&#xD;
             5 years prior to screening.&#xD;
&#xD;
          -  History or evidence of severe depression, schizophrenia, previous suicide attempts, or&#xD;
             suicidal ideation.&#xD;
&#xD;
        Prior/Concomitant Therapy:&#xD;
&#xD;
          -  Subjects who are unwilling to abstain from the use of TCS, TCI, and prescription&#xD;
             moisturizers (those that contain TCS and TCI) from screening through week 16 (applies&#xD;
             only to Part A subjects)&#xD;
&#xD;
          -  Subjects who have had side effects of topical medications including intolerance to&#xD;
             treatment, hypersensitivity reactions, significant skin atrophy, or systemic effects&#xD;
             as assessed by the investigator or by the subject's treating physician (applies only&#xD;
             to Part B subjects)&#xD;
&#xD;
          -  More than or equal to 30% of the total lesional surface is located on areas of thin&#xD;
             skin that cannot be safely treated with medium or higher potency TCS (eg, face, neck,&#xD;
             intertriginous areas, areas of skin atrophy) (applies only to Part B subjects)&#xD;
&#xD;
          -  Receipt of any approved biologic agent (eg, dupilumab) within 4 months or 5&#xD;
             elimination half-lives (whichever is longer) prior to screening&#xD;
&#xD;
          -  Have used immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids,&#xD;
             cyclosporine, mycophenolate-mofetil, interferon (IFN)-gamma, Janus kinase inhibitors,&#xD;
             azathioprine, methotrexate) within 4 weeks prior to screening, or any condition that,&#xD;
             in the opinion of the investigator, is likely to require such treatment(s) during the&#xD;
             first 4 weeks of study treatment.&#xD;
&#xD;
          -  Have had phototherapy for AD in the 2 months prior to day 1, and subjects unwilling to&#xD;
             avoid phototherapy during the first 16 weeks of the study&#xD;
&#xD;
          -  If on allergen-specific immunotherapy, subjects must be on a maintenance dose and&#xD;
             schedule for ≥ 28 days prior to screening. Allergen-specific immunotherapy is defined&#xD;
             as SC immunotherapy to aeroallergens and/o venom (Hymenoptera) as well as sublingual&#xD;
             immunotherapy to aeroallergens&#xD;
&#xD;
          -  Vaccination with a live or attenuated vaccine within 28 days prior to day 1. Receipt&#xD;
             of inactive/killed vaccinations (eg, inactive influenza) is allowed. Note that receipt&#xD;
             of the Th2 cytokine inhibitor suplatast within 15 days prior to randomization and&#xD;
             during the study is not allowed.&#xD;
&#xD;
          -  Major surgery within 8 weeks prior to screening or planned inpatient surgery or&#xD;
             hospitalization during the study period&#xD;
&#xD;
          -  Currently receiving treatment in another investigational device or drug study, or less&#xD;
             than 6 months since ending treatment on another investigational device or drug&#xD;
             study(ies). Other investigational procedures while participating in this study are&#xD;
             excluded.&#xD;
&#xD;
        Other Exclusions:&#xD;
&#xD;
          -  Female subject is pregnant or breastfeeding or planning to become pregnant or&#xD;
             breastfeed during treatment and for an additional 16 weeks after the last dose of&#xD;
             investigational product. (Females of childbearing potential should only be enrolled in&#xD;
             the study after a negative highly sensitive serum pregnancy test).&#xD;
&#xD;
          -  Female subjects of childbearing potential who are sexually active with unsterilized&#xD;
             male partners unwilling to use 1 highly effective method of contraception during&#xD;
             treatment and for an additional 16 weeks after the last dose of investigational&#xD;
             product. Cessation of contraception after this point must be discussed with a&#xD;
             responsible physician. Females of childbearing potential are defined as those who are&#xD;
             not surgically sterile (ie, had bilateral tubal ligation, bilateral oophorectomy, or&#xD;
             complete hysterectomy) or postmenopausal (defined as 12 months with no menses without&#xD;
             an alternative medical cause). A highly effective method of contraception is defined&#xD;
             as one that resulted in a low failure rate (ie, &lt; 1% per year) when used consistently&#xD;
             and correctly.&#xD;
&#xD;
          -  Subject has known sensitivity to any of the products or components to be administered&#xD;
             during dosing.&#xD;
&#xD;
          -  History or evidence of any other clinically significant disorder, condition or disease&#xD;
             (with the exception of those outlined above) that, in the opinion of the investigator&#xD;
             or Amgen physician, if consulted, would pose a risk to subject safety or interfere&#xD;
             with the study evaluation, procedures, or completion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>First OC Dermatology</name>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <zip>92708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Science Institute</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton Research, LLC</name>
      <address>
        <city>Alpharetta</city>
        <state>Georgia</state>
        <zip>30022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Illinois University School of Medicine</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dundee Dermatology</name>
      <address>
        <city>West Dundee</city>
        <state>Illinois</state>
        <zip>60118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Research</name>
      <address>
        <city>Clarksville</city>
        <state>Indiana</state>
        <zip>47129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epiphany Dermatology of Kansas, LLC</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin Sciences Pllc</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scott Health Services LLC</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clarkston Skin Research</name>
      <address>
        <city>Clarkston</city>
        <state>Michigan</state>
        <zip>48346</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J Woodson Dermatology and Associates</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DermResearch Center of New York Inc</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Clinical Research Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Modern Research Associates</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Clinical Research</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holdsworth House Medical Practice</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veracity Clinical Research</name>
      <address>
        <city>Woolloongabba</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin Health Institute</name>
      <address>
        <city>Carlton</city>
        <state>Victoria</state>
        <zip>3053</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Melbourne Hospital</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fremantle Dermatology</name>
      <address>
        <city>Fremantle</city>
        <state>Western Australia</state>
        <zip>6160</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Doctor Chih-Ho Hong Medical Incorporated</name>
      <address>
        <city>Surrey</city>
        <state>British Columbia</state>
        <zip>V3R 6A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DermEffects</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6H 5L5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynderm Research Inc</name>
      <address>
        <city>Markham</city>
        <state>Ontario</state>
        <zip>L3P 1X3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cheema Research Incorporated</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <zip>L5A 3V4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SKDS Research Incorporated</name>
      <address>
        <city>Newmarket</city>
        <state>Ontario</state>
        <zip>L3Y 5G8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gordon Sussman Clinical Research Incorporated</name>
      <address>
        <city>North York</city>
        <state>Ontario</state>
        <zip>M3B 3S6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JRB Research Incorporated</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 7X3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice u sv Anny v Brne</name>
      <address>
        <city>Brno</city>
        <zip>656 91</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnice Novy Jicin as</name>
      <address>
        <city>Novy Jicin</city>
        <zip>741 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Ostrava</name>
      <address>
        <city>Ostrava-Poruba</city>
        <zip>708 52</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorium profesora Arenbergera</name>
      <address>
        <city>Praha 1</city>
        <zip>110 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnice Na Bulovce</name>
      <address>
        <city>Praha 8</city>
        <zip>180 81</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Estonia Medical Centre</name>
      <address>
        <city>Tallinn</city>
        <zip>13419</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Centre</name>
      <address>
        <city>Tartu</city>
        <zip>50106</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tartu University Hospital</name>
      <address>
        <city>Tartu</city>
        <zip>50417</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CharitÃ© Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UniversitÃ¤tsmedizin GÃ¶ttingen - Georg-August-UniversitÃ¤t</name>
      <address>
        <city>GÃ¶ttingen</city>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Csalogany Orvosi Kozpont</name>
      <address>
        <city>Budapest</city>
        <zip>1027</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Obudai Egeszsegugyi Centrum Kft</name>
      <address>
        <city>Budapest</city>
        <zip>1036</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz</name>
      <address>
        <city>Debrecen</city>
        <zip>4031</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRU Hungary Kft</name>
      <address>
        <city>Miskolc</city>
        <zip>3529</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pecsi Tudomanyegyetem Klinikai Kozpont</name>
      <address>
        <city>Pecs</city>
        <zip>7632</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar</name>
      <address>
        <city>Szeged</city>
        <zip>6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toho University Sakura Medical Center</name>
      <address>
        <city>Sakura-shi</city>
        <state>Chiba</state>
        <zip>285-8741</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuoka University Hospital</name>
      <address>
        <city>Fukuoka-shi</city>
        <state>Fukuoka</state>
        <zip>814-0180</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takagi Dermatological Clinic</name>
      <address>
        <city>Obihiro-shi</city>
        <state>Hokkaido</state>
        <zip>080-0013</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Corporation Kojinkai Sapporo Skin Clinic</name>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokkaido</state>
        <zip>060-0063</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meiwa Hospital</name>
      <address>
        <city>Nishinomiya-shi</city>
        <state>Hyogo</state>
        <zip>663-8186</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagasaki University Hospital</name>
      <address>
        <city>Nagasaki-shi</city>
        <state>Nagasaki</state>
        <zip>852-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kume Clinic</name>
      <address>
        <city>Sakai-shi</city>
        <state>Osaka</state>
        <zip>593-8324</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nippon Medical School Hospital</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-8603</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Japan Post Holdings Co Ltd Tokyo Teishin Hospital</name>
      <address>
        <city>Chiyoda-ku</city>
        <state>Tokyo</state>
        <zip>102-8798</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NTT Medical Center Tokyo</name>
      <address>
        <city>Shinagawa-ku</city>
        <state>Tokyo</state>
        <zip>141-8625</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center Hospital of the National Center for Global Health and Medicine</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>162-8655</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shirasaki Dermatology Clinic</name>
      <address>
        <city>Takaoka-shi</city>
        <state>Toyama</state>
        <zip>933-0871</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hallym University Kangnam Sacred Heart Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>07441</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riga First Hospital</name>
      <address>
        <city>Riga</city>
        <zip>1001</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J Kisis</name>
      <address>
        <city>Riga</city>
        <zip>1003</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic Latvian Dermatology Institute</name>
      <address>
        <city>Riga</city>
        <zip>1011</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Outpatient Clinic of Ventspils</name>
      <address>
        <city>Ventspils</city>
        <zip>3601</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersyteckie Centrum Kliniczne</name>
      <address>
        <city>Gdansk</city>
        <zip>80-214</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo-Akcyjna</name>
      <address>
        <city>Lodz</city>
        <zip>90-242</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermoklinika Centrum Medyczne Spolka cywilna M Kierstan J Narbutt A Lesiak</name>
      <address>
        <city>Lodz</city>
        <zip>90-436</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niepubliczny Zaklad Opieki Zdrowotnej Med Laser Borzecki Spolka Jawna</name>
      <address>
        <city>Lublin</city>
        <zip>20-406</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tomasz Blicharski Lubelskie Centrum Diagnostyczne</name>
      <address>
        <city>Swidnik</city>
        <zip>21-040</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Pratia Warszawa</name>
      <address>
        <city>Warszawa</city>
        <zip>01-868</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medicus Sp z o o</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-224</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DermMedica Spzoo</name>
      <address>
        <city>Wroclaw</city>
        <zip>51-318</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen Macarena</name>
      <address>
        <city>Sevilla</city>
        <state>AndalucÃ-a</state>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <state>CataluÃ±a</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <state>CataluÃ±a</state>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <state>CataluÃ±a</state>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Alicante</name>
      <address>
        <city>Alicante</city>
        <state>Comunidad Valenciana</state>
        <zip>03010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de La Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chernivtsi Regional Skin and Venereal Dispensary</name>
      <address>
        <city>Chernivtsi</city>
        <zip>58002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Skin and Venereal Dispensary</name>
      <address>
        <city>Dnipro</city>
        <zip>49074</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ivano-Frankivsk Regional Skin and Venereal Dispensary</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical clinic Blagomed</name>
      <address>
        <city>Kyiv</city>
        <zip>02000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asclepius</name>
      <address>
        <city>Uzhhorod</city>
        <zip>88000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Military Hospital, Military Unit A3309 of the Military Medical Clinical Center</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ninewells Hospital</name>
      <address>
        <city>Dundee</city>
        <zip>DD1 9SY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Whipps Cross University Hospital</name>
      <address>
        <city>London</city>
        <zip>E11 1NR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southampton General Hospital</name>
      <address>
        <city>Southampton</city>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Estonia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Latvia</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <results_first_submitted>January 25, 2022</results_first_submitted>
  <results_first_submitted_qc>March 9, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 10, 2022</results_first_posted>
  <disposition_first_submitted>February 18, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>March 9, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 10, 2022</disposition_first_posted>
  <last_update_submitted>March 9, 2022</last_update_submitted>
  <last_update_submitted_qc>March 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atopic Dermatitis</keyword>
  <keyword>eczema</keyword>
  <keyword>tezepelumab</keyword>
  <keyword>dermatology</keyword>
  <keyword>dermatitis</keyword>
  <keyword>inflammation</keyword>
  <keyword>skin</keyword>
  <keyword>moderate dermatitis</keyword>
  <keyword>severe dermatitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.</ipd_access_criteria>
    <ipd_url>https://www.amgen.com/datasharing</ipd_url>
  </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>August 25, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT03809663/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>June 4, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT03809663/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled in 78 centers in 14 countries including Australia, Canada, Czech Republic, Estonia, Germany, Hungary, Japan, Latvia, Poland, Republic of Korea, Spain, Ukraine, the United Kingdom, and the United States.</recruitment_details>
      <pre_assignment_details>Enrollment of Part A of this study was completed as of 27 July 2020. The study was terminated prior to the enrollment of any participants into Part B.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part A: Placebo</title>
          <description>Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index [EASI] compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
        </group>
        <group group_id="P2">
          <title>Part A: Tezepelumab 210 mg Q4W</title>
          <description>Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.&#xD;
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
        </group>
        <group group_id="P3">
          <title>Part A: Tezepelumab 280 mg Q2W</title>
          <description>Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.&#xD;
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
        </group>
        <group group_id="P4">
          <title>Part A: Tezepelumab 420 mg Q2W</title>
          <description>Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
        </group>
        <group group_id="P5">
          <title>Part B: Placebo and Topical Corticosteroids Regimen</title>
          <description>Matching placebo was planned to be administered via SC injection Q2W with topical corticosteroids (TCS) for a maximum of 52 weeks.&#xD;
The study was terminated prior to the start of Part 2 and no participants were enrolled.</description>
        </group>
        <group group_id="P6">
          <title>Part B: Tezepelumab 420 mg Q2W and Topical Corticosteroids Regimen</title>
          <description>Tezepelumab 420 mg was planned to be administered via SC injection Q2W with TCS for a maximum of 52 weeks.&#xD;
The study was terminated prior to the start of Part 2 and no participants were enrolled.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="63"/>
                <participants group_id="P2" count="62"/>
                <participants group_id="P3" count="63"/>
                <participants group_id="P4" count="63"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participants Who Received Investigational Product</title>
              <participants_list>
                <participants group_id="P1" count="63"/>
                <participants group_id="P2" count="61"/>
                <participants group_id="P3" count="63"/>
                <participants group_id="P4" count="63"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>EASI 50 Non-responder at Week 16</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="30"/>
                <participants group_id="P4" count="38"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Switched to Tezepelumab 420 mg Q2W After Week 16</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="30"/>
                <participants group_id="P4" count="38"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="16"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="44"/>
                <participants group_id="P3" count="48"/>
                <participants group_id="P4" count="47"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Decision by sponsor</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="20"/>
                <participants group_id="P4" count="20"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="27"/>
                <participants group_id="P4" count="26"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full analysis set (FAS): All randomized participants in Part A.</population>
      <group_list>
        <group group_id="B1">
          <title>Part A: Placebo</title>
          <description>Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index [EASI] compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
        </group>
        <group group_id="B2">
          <title>Part A: Tezepelumab 210 mg Q4W</title>
          <description>Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.&#xD;
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
        </group>
        <group group_id="B3">
          <title>Part A: Tezepelumab 280 mg Q2W</title>
          <description>Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.&#xD;
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
        </group>
        <group group_id="B4">
          <title>Part A: Tezepelumab 420 mg Q2W</title>
          <description>Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
        </group>
        <group group_id="B5">
          <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="63"/>
            <count group_id="B2" value="62"/>
            <count group_id="B3" value="63"/>
            <count group_id="B4" value="63"/>
            <count group_id="B5" value="251"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.7" spread="13.4"/>
                    <measurement group_id="B2" value="38.5" spread="15.0"/>
                    <measurement group_id="B3" value="36.9" spread="13.4"/>
                    <measurement group_id="B4" value="40.7" spread="14.3"/>
                    <measurement group_id="B5" value="37.9" spread="14.1"/>
                  </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="27"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="27"/>
                    <measurement group_id="B5" value="109"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="36"/>
                    <measurement group_id="B5" value="142"/>
                  </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="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="62"/>
                    <measurement group_id="B4" value="59"/>
                    <measurement group_id="B5" value="236"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</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="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African-American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="8"/>
                  </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_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="45"/>
                    <measurement group_id="B4" value="47"/>
                    <measurement group_id="B5" value="175"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</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_list>
                </category>
                <category>
                  <title>Other</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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Investigator's Global Assessment Score</title>
          <description>The IGA allows investigators to assess overall disease severity at 1 given time point and consists of a 6-point severity scale from clear to severe disease&#xD;
0 = clear&#xD;
1 = almost clear&#xD;
2 = mild disease&#xD;
3 = moderate disease&#xD;
4 = severe disease&#xD;
5 = very severe disease The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing &amp; crusting as guidelines for the overall severity assessment (Breuer et al 2004).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>IGA Score of 3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="37"/>
                    <measurement group_id="B5" value="126"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IGA Score of 4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="97"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IGA Score of 5</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Eczema Area and Severity Index (EASI)</title>
          <description>The EASI was designed by modifying the Psoriasis Area and Severity Index (Schmitt et al, 2007). The EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on key acute and chronic signs of inflammation (ie, erythema, induration/papulation, excoriation, and lichenification).&#xD;
The lowest possible total score is 0 and the highest possible total score is 72, with higher scores indicating greater severity of eczema.</description>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.0" spread="11.1"/>
                    <measurement group_id="B2" value="28.4" spread="13.2"/>
                    <measurement group_id="B3" value="30.3" spread="10.7"/>
                    <measurement group_id="B4" value="28.6" spread="12.4"/>
                    <measurement group_id="B5" value="29.8" spread="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) (IGA 0/1) at Week 16</title>
        <description>The IGA allows investigators to assess overall disease severity at 1 given time point and consists of a 6-point severity scale from clear to severe disease&#xD;
0 = clear&#xD;
1 = almost clear&#xD;
2 = mild disease&#xD;
3 = moderate disease&#xD;
4 = severe disease&#xD;
5 = very severe disease&#xD;
The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment (Breuer et al, 2004).&#xD;
Participants who took rescue medication between Day 29 to Week 16 were considered non-responders.</description>
        <time_frame>Week 16</time_frame>
        <population>FAS: All randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: Placebo</title>
            <description>Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index [EASI] compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
          <group group_id="O2">
            <title>Part A: Tezepelumab 210 mg Q4W</title>
            <description>Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.&#xD;
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
          <group group_id="O3">
            <title>Part A: Tezepelumab 280 mg Q2W</title>
            <description>Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.&#xD;
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
          <group group_id="O4">
            <title>Part A: Tezepelumab 420 mg Q2W</title>
            <description>Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) (IGA 0/1) at Week 16</title>
          <description>The IGA allows investigators to assess overall disease severity at 1 given time point and consists of a 6-point severity scale from clear to severe disease&#xD;
0 = clear&#xD;
1 = almost clear&#xD;
2 = mild disease&#xD;
3 = moderate disease&#xD;
4 = severe disease&#xD;
5 = very severe disease&#xD;
The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment (Breuer et al, 2004).&#xD;
Participants who took rescue medication between Day 29 to Week 16 were considered non-responders.</description>
          <population>FAS: All randomized participants.</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="63"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="63"/>
                <count group_id="O4" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.56</p_value>
            <p_value_desc>Nominal p-value</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.686</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.290</ci_lower_limit>
            <ci_upper_limit>9.809</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.99</p_value>
            <p_value_desc>Nominal p-value</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.011</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.135</ci_lower_limit>
            <ci_upper_limit>7.551</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.38</p_value>
            <p_value_desc>Nominal p-value</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.146</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.390</ci_lower_limit>
            <ci_upper_limit>11.800</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Experienced a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16</title>
        <description>The EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on key acute and chronic signs of inflammation (ie, erythema, induration/papulation, excoriation, and lichenification).&#xD;
A reduction in the EASI score indicates an improvement in severity. Participants who took rescue medication between Day 29 to Week 16 were considered non-responders.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>FAS: All randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: Placebo</title>
            <description>Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index [EASI] compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
          <group group_id="O2">
            <title>Part A: Tezepelumab 210 mg Q4W</title>
            <description>Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.&#xD;
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
          <group group_id="O3">
            <title>Part A: Tezepelumab 280 mg Q2W</title>
            <description>Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.&#xD;
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
          <group group_id="O4">
            <title>Part A: Tezepelumab 420 mg Q2W</title>
            <description>Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16</title>
          <description>The EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on key acute and chronic signs of inflammation (ie, erythema, induration/papulation, excoriation, and lichenification).&#xD;
A reduction in the EASI score indicates an improvement in severity. Participants who took rescue medication between Day 29 to Week 16 were considered non-responders.</description>
          <population>FAS: All randomized participants.</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="63"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="63"/>
                <count group_id="O4" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.97</p_value>
            <p_value_desc>Nominal p-value</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.982</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.344</ci_lower_limit>
            <ci_upper_limit>2.803</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.70</p_value>
            <p_value_desc>Nominal p-value</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.217</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.441</ci_lower_limit>
            <ci_upper_limit>3.356</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.58</p_value>
            <p_value_desc>Nominal p-value</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.730</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.243</ci_lower_limit>
            <ci_upper_limit>2.197</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced a 50% or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI 50/90) at Week 16</title>
        <description>The EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on key acute and chronic signs of inflammation (ie, erythema, induration/papulation, excoriation, and lichenification).&#xD;
A reduction in the EASI score indicates an improvement in severity. Participants who took rescue medication between Day 29 to Week 16 were considered non-responders.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>FAS: All randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: Placebo</title>
            <description>Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index [EASI] compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
          <group group_id="O2">
            <title>Part A: Tezepelumab 210 mg Q4W</title>
            <description>Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.&#xD;
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
          <group group_id="O3">
            <title>Part A: Tezepelumab 280 mg Q2W</title>
            <description>Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.&#xD;
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
          <group group_id="O4">
            <title>Part A: Tezepelumab 420 mg Q2W</title>
            <description>Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced a 50% or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI 50/90) at Week 16</title>
          <description>The EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on key acute and chronic signs of inflammation (ie, erythema, induration/papulation, excoriation, and lichenification).&#xD;
A reduction in the EASI score indicates an improvement in severity. Participants who took rescue medication between Day 29 to Week 16 were considered non-responders.</description>
          <population>FAS: All randomized participants.</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="56"/>
                <count group_id="O2" value="58"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EASI 50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EASI 90</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Achievement of 50%, 75% or 90% Reduction From Day 1 in Eczema Area and Severity Index (EASI 50/75/90)</title>
        <time_frame>Day 1 up to End of Study Visit (Week 70)</time_frame>
        <population>FAS: All randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: Placebo</title>
            <description>Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index [EASI] compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
          <group group_id="O2">
            <title>Part A: Tezepelumab 210 mg Q4W</title>
            <description>Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.&#xD;
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
          <group group_id="O3">
            <title>Part A: Tezepelumab 280 mg Q2W</title>
            <description>Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.&#xD;
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
          <group group_id="O4">
            <title>Part A: Tezepelumab 420 mg Q2W</title>
            <description>Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Achievement of 50%, 75% or 90% Reduction From Day 1 in Eczema Area and Severity Index (EASI 50/75/90)</title>
          <population>FAS: All randomized participants.</population>
          <units>Weeks</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="63"/>
                <count group_id="O4" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time to EASI 50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.143" lower_limit="4.14" upper_limit="19.57"/>
                    <measurement group_id="O2" value="8.143" lower_limit="3.86" upper_limit="16.14"/>
                    <measurement group_id="O3" value="6.286" lower_limit="3.86" upper_limit="22.14"/>
                    <measurement group_id="O4" value="5.857" lower_limit="3.86" upper_limit="16.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time to EASI 75</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.143" lower_limit="4.14" upper_limit="19.57"/>
                    <measurement group_id="O2" value="6.286" lower_limit="4.00" upper_limit="16.43"/>
                    <measurement group_id="O3" value="6.714" lower_limit="4.14" upper_limit="22.14"/>
                    <measurement group_id="O4" value="6.429" lower_limit="4.14" upper_limit="16.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time to EASI 90</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.286" lower_limit="4.43" upper_limit="19.57"/>
                    <measurement group_id="O2" value="10.929" lower_limit="4.00" upper_limit="16.14"/>
                    <measurement group_id="O3" value="10.071" lower_limit="6.14" upper_limit="16.14"/>
                    <measurement group_id="O4" value="7.286" lower_limit="4.14" upper_limit="16.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 16</title>
        <description>The SCORAD is a clinical tool for assessing the severity (ie, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with subjective symptoms (Kunz et al, 1997). The total score ranges from 0 to 103, with higher values indicating more severe disease. A negative change from baseline indicates an improvement in severity of disease.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>FAS: All randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: Placebo</title>
            <description>Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index [EASI] compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
          <group group_id="O2">
            <title>Part A: Tezepelumab 210 mg Q4W</title>
            <description>Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.&#xD;
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
          <group group_id="O3">
            <title>Part A: Tezepelumab 280 mg Q2W</title>
            <description>Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.&#xD;
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
          <group group_id="O4">
            <title>Part A: Tezepelumab 420 mg Q2W</title>
            <description>Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 16</title>
          <description>The SCORAD is a clinical tool for assessing the severity (ie, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with subjective symptoms (Kunz et al, 1997). The total score ranges from 0 to 103, with higher values indicating more severe disease. A negative change from baseline indicates an improvement in severity of disease.</description>
          <population>FAS: All randomized participants.</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="63"/>
                <count group_id="O4" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.00" spread="2.55"/>
                    <measurement group_id="O2" value="-16.75" spread="2.40"/>
                    <measurement group_id="O3" value="-11.87" spread="2.49"/>
                    <measurement group_id="O4" value="-9.32" spread="2.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16</title>
        <description>Pruritus was assessed using an NRS (0-10) with 0 = no itch and 10 = worst imaginable itch. A negative change from baseline indicates an improvement in symptoms.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>FAS: All randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: Placebo</title>
            <description>Matching placebo administered via subcutaneous (SC) injection once every 2 weeks (Q2W) for a maximum of 52 weeks.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in Eczema Area and Severity Index [EASI] compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
          <group group_id="O2">
            <title>Part A: Tezepelumab 210 mg Q4W</title>
            <description>Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.&#xD;
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
          <group group_id="O3">
            <title>Part A: Tezepelumab 280 mg Q2W</title>
            <description>Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.&#xD;
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
          <group group_id="O4">
            <title>Part A: Tezepelumab 420 mg Q2W</title>
            <description>Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16</title>
          <description>Pruritus was assessed using an NRS (0-10) with 0 = no itch and 10 = worst imaginable itch. A negative change from baseline indicates an improvement in symptoms.</description>
          <population>FAS: All randomized participants.</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="63"/>
                <count group_id="O4" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.71" spread="0.30"/>
                    <measurement group_id="O2" value="-1.40" spread="0.27"/>
                    <measurement group_id="O3" value="-0.94" spread="0.28"/>
                    <measurement group_id="O4" value="-0.38" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Trough Concentrations of Tezepelumab After Q2W or Q4W Administration</title>
        <description>Switchers were included up to Week 16 and were then excluded from the analysis after switching. All Tezepelumab participants received 420 mg of Tezepelumab on Day 1.</description>
        <time_frame>Pre-dose on Day 1, Week 2, 4, 12, 16, 24, 32, 40, 48, 50, 52, 58 and 70</time_frame>
        <population>All randomized participants who received at least 1 dose of investigational product with analyzable samples at each time point. Participants were analyzed according to the highest dose of actual treatment received after initial first dose or only dose received. Switchers were included up to Week 16 and were then excluded from the analysis after switching at Week 16.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: Tezepelumab 210 mg Q4W</title>
            <description>Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.&#xD;
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received a placebo at Week 2 and every other week to maintain blinding.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
          <group group_id="O2">
            <title>Part A: Tezepelumab 280 mg Q2W</title>
            <description>Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.&#xD;
All participants randomized to tezepelumab received 420 mg SC injection as their first dose. Participants then received their randomized dose of 280 mg Q2W from Week 2.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 switched to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
          <group group_id="O3">
            <title>Part A: Tezepelumab 420 mg Q2W</title>
            <description>Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.&#xD;
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI compared to baseline) at Week 16 stayed to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Trough Concentrations of Tezepelumab After Q2W or Q4W Administration</title>
          <description>Switchers were included up to Week 16 and were then excluded from the analysis after switching. All Tezepelumab participants received 420 mg of Tezepelumab on Day 1.</description>
          <population>All randomized participants who received at least 1 dose of investigational product with analyzable samples at each time point. Participants were analyzed according to the highest dose of actual treatment received after initial first dose or only dose received. Switchers were included up to Week 16 and were then excluded from the analysis after switching at Week 16.</population>
          <units>µg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="58"/>
                <count group_id="O3" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="58"/>
                    <count group_id="O2" value="58"/>
                    <count group_id="O3" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00031" spread="0.00236"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                    <measurement group_id="O3" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.9" spread="10.9"/>
                    <measurement group_id="O2" value="36.3" spread="12.9"/>
                    <measurement group_id="O3" value="34.8" spread="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.4" spread="9.03"/>
                    <measurement group_id="O2" value="48.8" spread="16.0"/>
                    <measurement group_id="O3" value="58.9" spread="21.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.7" spread="8.47"/>
                    <measurement group_id="O2" value="66.7" spread="22.9"/>
                    <measurement group_id="O3" value="97.0" spread="35.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2" spread="9.42"/>
                    <measurement group_id="O2" value="77.4" spread="33.0"/>
                    <measurement group_id="O3" value="98.0" spread="37.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="17"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.2" spread="10.6"/>
                    <measurement group_id="O2" value="83.6" spread="31.2"/>
                    <measurement group_id="O3" value="107" spread="29.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.4" spread="17.0"/>
                    <measurement group_id="O2" value="75.1" spread="36.3"/>
                    <measurement group_id="O3" value="81.4" spread="26.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.9" spread="12.7"/>
                    <measurement group_id="O2" value="76.8" spread="19.7"/>
                    <measurement group_id="O3" value="112" spread="63.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2" spread="6.49"/>
                    <measurement group_id="O2" value="76.4" spread="26.4"/>
                    <measurement group_id="O3" value="118" spread="48.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.2" spread="9.11"/>
                    <measurement group_id="O2" value="86.8" spread="27.7"/>
                    <measurement group_id="O3" value="113" spread="44.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.3" spread="7.24"/>
                    <measurement group_id="O2" value="67.2" spread="33.2"/>
                    <measurement group_id="O3" value="102" spread="31.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 58</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.41" spread="2.56"/>
                    <measurement group_id="O2" value="18.0" spread="7.09"/>
                    <measurement group_id="O3" value="20.9" spread="NA">Insufficient samples to measure standard deviation.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 70</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.699" spread="0.380"/>
                    <measurement group_id="O2" value="1.87" spread="1.74"/>
                    <measurement group_id="O3" value="5.36" spread="3.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Trough Concentrations of Tezepelumab After Switching to 420 mg Q2W Administration After Week 16</title>
        <time_frame>Pre-dose on Week 24, 32, 40, 48, 50, 52, 58 and 70</time_frame>
        <population>All randomized participants who received at least 1 dose of investigational product who were assessed as EASI non-responders at Week 16 and switched to 420 mg Q2W, with analyzable samples at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: Placebo up to Week 16; Tezepelumab 420 mg Week 16 to 52 (Switchers)</title>
            <description>All participants who received the matching placebo Q2W up to Week 16 and were assessed as EASI 50 non-responders and switched to receive tezepelumab 420 mg Q2W up to Week 52.&#xD;
Tezepelumab 420 mg administered via SC injection Q2W from Week 18 to Week 52.</description>
          </group>
          <group group_id="O2">
            <title>Part A: Tezepelumab 210 mg up to Week 16; Tezepelumab 420 mg Week 16 to 52 (Switchers)</title>
            <description>All participants who received tezepelumab 210 mg Q4W up to Week 16 and were assessed as EASI 50 non-responders and switched to receive tezepelumab 420 mg Q2W up to Week 52 (switchers).&#xD;
Tezepelumab 420 mg administered via SC injection Q2W from Week 18 to Week 52.</description>
          </group>
          <group group_id="O3">
            <title>Part A: Tezepelumab 280 mg up to Week 16; Tezepelumab 420 mg Week 16 to 52 (Switchers)</title>
            <description>All participants who received tezepelumab 280 mg Q2W up to Week 16 and were assessed as EASI 50 non-responders and switched to receive tezepelumab 420 mg Q2W up to Week 52 (switchers).&#xD;
Tezepelumab 420 mg administered via SC injection Q2W from Week 18 to Week 52.</description>
          </group>
          <group group_id="O4">
            <title>Part A: Tezepelumab 420 mg up to Week 16; Tezepelumab 420 mg Week 16 to 52 (Switchers)</title>
            <description>All participants who received tezepelumab 420 mg Q2W up to Week 16 and were assessed as EASI 50 non-responders and continued to receive tezepelumab 420 mg Q2W up to Week 52.&#xD;
Tezepelumab 420 mg administered via SC injection Q2W from Week 18 to Week 52.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Trough Concentrations of Tezepelumab After Switching to 420 mg Q2W Administration After Week 16</title>
          <population>All randomized participants who received at least 1 dose of investigational product who were assessed as EASI non-responders at Week 16 and switched to 420 mg Q2W, with analyzable samples at each time point.</population>
          <units>µg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.5" spread="28.3"/>
                    <measurement group_id="O2" value="87.2" spread="24.0"/>
                    <measurement group_id="O3" value="96.6" spread="29.2"/>
                    <measurement group_id="O4" value="100" spread="38.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.0" spread="38.7"/>
                    <measurement group_id="O2" value="104" spread="38.8"/>
                    <measurement group_id="O3" value="97.8" spread="39.3"/>
                    <measurement group_id="O4" value="105" spread="39.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117" spread="42.7"/>
                    <measurement group_id="O2" value="93.8" spread="35.5"/>
                    <measurement group_id="O3" value="113" spread="31.1"/>
                    <measurement group_id="O4" value="101" spread="37.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="134" spread="60.2"/>
                    <measurement group_id="O2" value="121" spread="29.1"/>
                    <measurement group_id="O3" value="89.6" spread="35.1"/>
                    <measurement group_id="O4" value="103" spread="29.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115" spread="39.0"/>
                    <measurement group_id="O2" value="125" spread="42.2"/>
                    <measurement group_id="O3" value="79.1" spread="38.6"/>
                    <measurement group_id="O4" value="106" spread="27.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125" spread="30.8"/>
                    <measurement group_id="O2" value="113" spread="45.0"/>
                    <measurement group_id="O3" value="88.3" spread="33.0"/>
                    <measurement group_id="O4" value="105" spread="30.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 58</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.0" spread="21.6"/>
                    <measurement group_id="O2" value="52.6" spread="NA">Insufficient number of samples to calculate standard deviation.</measurement>
                    <measurement group_id="O3" value="36.7" spread="NA">Insufficient number of samples to calculate standard deviation.</measurement>
                    <measurement group_id="O4" value="17.6" spread="9.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 70</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.07" spread="5.10"/>
                    <measurement group_id="O2" value="4.47" spread="3.39"/>
                    <measurement group_id="O3" value="2.60" spread="1.72"/>
                    <measurement group_id="O4" value="3.49" spread="2.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to week 16 for Arms 1-4 and after week 16 up to week 70 for Arms 5-12</time_frame>
      <desc>Other Adverse Events include all non-serious events that occurred at a frequency of greater than or equal to 5 percent.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants who took placebo from Week 1 to Week 16.</description>
        </group>
        <group group_id="E2">
          <title>Tezepelumab 210 mg Q4W</title>
          <description>Participants who took 210 mg Q4W from Week 1 to Week 16.</description>
        </group>
        <group group_id="E3">
          <title>Tezepelumab 280 mg Q2W</title>
          <description>Participants who took 280 mg Q2W from Week 1 to Week 16.</description>
        </group>
        <group group_id="E4">
          <title>Tezepelumab 420 mg Q2W</title>
          <description>Participants who took 420 mg Q2W from Week 1 to Week 16.&#xD;
Includes 7 subjects randomized to the lower doses of Tezepelumab but received only the first dose of Tezepelumab 420 mg SC and early discontinued.</description>
        </group>
        <group group_id="E5">
          <title>Placebo - Placebo</title>
          <description>Non-switching participants who took placebo from Week 16 to Week 52.</description>
        </group>
        <group group_id="E6">
          <title>Tezepelumab 210 mg Q4W - 210 mg Q4W</title>
          <description>Non-switching participants who took 210 mg Q4W from Week 16 to Week 52.</description>
        </group>
        <group group_id="E7">
          <title>Tezepelumab 280 mg Q2W - 280 mg Q2W</title>
          <description>Non-switching participants who took 280 mg Q2W from Week 16 to Week 52.</description>
        </group>
        <group group_id="E8">
          <title>Tezepelumab 420 mg Q2W - 420 mg Q2W</title>
          <description>Non-switching participants who continued to take 420 mg Q2W from Week 16 to Week 52.&#xD;
Includes 6 participants who were randomized to placebo (n=2), 210 mg Q4W (n=3) and 280 mg Q2W (n=1) but switched to Tezepelumab 420 mg SC Q2W in error after Week 16.</description>
        </group>
        <group group_id="E9">
          <title>Placebo- Tezepelumab 420 mg Q2W</title>
          <description>Participants who switched after Week 16 to take 420 mg Q2W.</description>
        </group>
        <group group_id="E10">
          <title>Tezepelumab 210 mg Q4W-420 mg Q2W</title>
          <description>Participants who switched after Week 16 to take 420 mg Q2W.</description>
        </group>
        <group group_id="E11">
          <title>Tezepelumab 280 mg Q2W-420 mg Q2W</title>
          <description>Participants who switched after Week 16 to take 420 mg Q2W.</description>
        </group>
        <group group_id="E12">
          <title>Tezepelumab 420 mg Q2W-420 mg Q2W</title>
          <description>Participants who switched after week 16 who continued to take 420 mg Q2W.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="4" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Corneal degeneration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Alcohol abuse</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Dermatitis herpetiformis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Skin erosion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.1</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="25" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="29" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="30" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="11" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="18" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="9" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="10" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="19" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Chalazion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Condition aggravated</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Temperature intolerance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Food allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Eczema herpeticum</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="3" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="3" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="3" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Pyoderma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod sting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>SARS-CoV-2 antibody test positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="38"/>
              </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="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="9" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="6" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="3" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Hand dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Intertrigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Skin striae</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="38"/>
              </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 Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Enrollment of Part A of this study was completed as of 27 July 2020. The study was terminated prior to the enrollment of any participants into Part B.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Amgen Inc.</organization>
      <phone>866-572-6436</phone>
      <email>medinfo@amgen.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/NCT03809663
org study id: 20170755
secondary id: 2018-001997-52
nct id: NCT03809663
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This phase 2b study is designed to evaluate the safety and efficacy of tezepelumab as a
      monotherapy and explore its efficacy as adjunct therapy in subjects with moderate-to-severe
      atopic dermatitis (AD).
All subjects will receive a subcutaneous (SC) dose of either investigational product or
      placebo as the first dose on day 1.

      Subjects who are determined to be non-responders in Part A will receive tezepelumab SC every
      2 weeks (Q2W) following completion of all week 16 study activities. Nonresponders are defined
      as those subjects who have not achieved at least a 50% improvement in Eczema Area and
      Severity Index (EASI) at week 16 compared to baseline (day 1).

      Safety follow-up is 18 weeks after the end of treatment (EOT) visit (20 weeks after the final
      dose of investigational product).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This phase 2b study is designed to evaluate the safety and efficacy of tezepelumab as a monotherapy and explore its efficacy as adjunct therapy in subjects with moderate-to-severe AD. This study consists of Part A (the main study evaluating tezepelumab as a monotherapy) and Part B (a study evaluating tezepelumab as adjunctive therapy when combined with a topical corticosteroid regimen
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) (IGA 0/1) at Week 16
time frame: Week 16
description: The IGA allows investigators to assess overall disease severity at 1 given time point and consists of a 6-point severity scale from clear to severe disease
0 = clear
1 = almost clear
2 = mild disease
3 = moderate disease
4 = severe disease
5 = very severe disease
The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment (Breuer et al, 2004).
Participants who took rescue medication between Day 29 to Week 16 were considered non-responders.
measure: Number of Participants Who Experienced a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16
time frame: Baseline and Week 16
description: The EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on key acute and chronic signs of inflammation (ie, erythema, induration/papulation, excoriation, and lichenification).
A reduction in the EASI score indicates an improvement in severity. Participants who took rescue medication between Day 29 to Week 16 were considered non-responders.
measure: Number of Participants Who Experienced a 50% or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI 50/90) at Week 16
time frame: Baseline and Week 16
description: The EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on key acute and chronic signs of inflammation (ie, erythema, induration/papulation, excoriation, and lichenification).
A reduction in the EASI score indicates an improvement in severity. Participants who took rescue medication between Day 29 to Week 16 were considered non-responders.
measure: Time to Achievement of 50%, 75% or 90% Reduction From Day 1 in Eczema Area and Severity Index (EASI 50/75/90)
time frame: Day 1 up to End of Study Visit (Week 70)
measure: Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 16
time frame: Baseline and Week 16
description: The SCORAD is a clinical tool for assessing the severity (ie, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with subjective symptoms (Kunz et al, 1997). The total score ranges from 0 to 103, with higher values indicating more severe disease. A negative change from baseline indicates an improvement in severity of disease.
measure: Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16
time frame: Baseline and Week 16
description: Pruritus was assessed using an NRS (0-10) with 0 = no itch and 10 = worst imaginable itch. A negative change from baseline indicates an improvement in symptoms.
measure: Serum Trough Concentrations of Tezepelumab After Q2W or Q4W Administration
time frame: Pre-dose on Day 1, Week 2, 4, 12, 16, 24, 32, 40, 48, 50, 52, 58 and 70
description: Switchers were included up to Week 16 and were then excluded from the analysis after switching. All Tezepelumab participants received 420 mg of Tezepelumab on Day 1.
measure: Serum Trough Concentrations of Tezepelumab After Switching to 420 mg Q2W Administration After Week 16
time frame: Pre-dose on Week 24, 32, 40, 48, 50, 52, 58 and 70
arm group label: Part A: Placebo
arm group type: Placebo Comparator
description: Matching placebo administered via SC injection Q2W for a maximum of 52 weeks.
Participants defined as non-responders (those who do not achieve at least 50% improvement in EASI at Week 16 compared to baseline) will switch to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study beginning with the Week 18 dose.
arm group label: Part A: Tezepelumab 210 mg
arm group type: Experimental
description: Tezepelumab 210 mg administered via SC injection once every 4 weeks (Q4W) from Week 4 for a maximum of 52 weeks.
All participants randomized to tezepelumab will receive 420 mg SC injection as their first dose. Participants will then receive a placebo at Week 2 to maintain blinding.
Participants defined as non-responders (those who do not achieve at least 50% improvement in EASI at Week 16 compared to baseline) will switch to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study beginning with the Week 18 dose.
arm group label: Part A: Tezepelumab 280 mg
arm group type: Experimental
description: Tezepelumab 280 mg administered via SC injection Q2W from Week 2 for a maximum of 52 weeks.
All participants randomized to tezepelumab will receive 420 mg SC injection as their first dose. Participants will then receive their randomized dose of 280 mg Q2W from Week 2.
Participants defined as non-responders (those who did not achieve at least 50% improvement in EASI at Week 16 compared to baseline) will switch to receive tezepelumab 420 mg SC injection Q2W for the remainder of the study beginning with the Week 18 dose.
arm group label: Part A: Tezepelumab 420 mg
arm group type: Experimental
description: Tezepelumab 420 mg administered via SC injection Q2W for a maximum of 52 weeks.
arm group label: Part B: Placebo and Topical Corticosteroids Regimen
arm group type: Experimental
description: Matching placebo administered via SC injection Q2W with topical corticosteroids (TCS) for a maximum of 52 weeks.
arm group label: Part B: Tezepelumab 420 mg and Topical Corticosteroids Regimen
arm group type: Experimental
description: Tezepelumab 420 mg administered via SC injection Q2W with TCS for a maximum of 52 weeks.
intervention type: Drug
intervention name: Tezepelumab
description: Solution for injection
arm group label: Part A: Tezepelumab 210 mg
arm group label: Part A: Tezepelumab 280 mg
arm group label: Part A: Tezepelumab 420 mg
arm group label: Part B: Placebo and Topical Corticosteroids Regimen
arm group label: Part B: Tezepelumab 420 mg and Topical Corticosteroids Regimen
other name: AMG157
intervention type: Other
intervention name: Placebo
description: Placebo solution for injection
arm group label: Part A: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
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country: Australia
country: Canada
country: Czechia
country: Estonia
country: Germany
country: Hungary
country: Japan
country: Korea, Republic of
country: Latvia
country: Poland
country: Spain
country: Switzerland
country: Ukraine
country: United Kingdom
country: United States
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: Yes
ipd description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
ipd access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
ipd url: https://www.amgen.com/datasharing
provided document: 
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participant flow: 
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outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Enrollment of Part A of this study was completed as of 27 July 2020. The study was terminated prior to the enrollment of any participants into Part B.
point of contact: 