<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/NCT03831191</url>
  </required_header>
  <id_info>
    <org_study_id>17104</org_study_id>
    <secondary_id>I9N-MC-FCAB</secondary_id>
    <secondary_id>2018-002401-56</secondary_id>
    <nct_id>NCT03831191</nct_id>
  </id_info>
  <brief_title>A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis</brief_title>
  <acronym>ADmIRe</acronym>
  <official_title>A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3375880 in Adult Subjects With Moderate-to-Severe Atopic Dermatitis: The ADmIRe Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</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>
      The reason for this study is to see if the study drug LY3375880 is safe and effective in&#xD;
      adults with moderate-to-severe atopic dermatitis (AD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated for lack of efficacy after an interim analysis was performed&#xD;
  </why_stopped>
  <start_date type="Actual">February 12, 2019</start_date>
  <completion_date type="Actual">February 27, 2020</completion_date>
  <primary_completion_date type="Actual">February 27, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving Validated Investigator's Global Assessment for AD (vIGA-AD) of 0 or 1 With a ≥2 Point Improvement</measure>
    <time_frame>Week 16</time_frame>
    <description>vIGA-AD measures participants' overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity.The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75)</measure>
    <time_frame>Week 16</time_frame>
    <description>EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs - by scoring the extent of disease (percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. Each body site will have a score that ranges from 0 to 72, and the final EASI score will be obtained by weight-averaging these 4 scores. Hence, the final EASI score will range from 0 to 72 (severe) for each time point. A higher score represented greater disease severity.The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. Non-responder imputation (NRI) method was used to impute missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD-75)</measure>
    <time_frame>Week 16</time_frame>
    <description>The SCORAD index uses the rule of nines to assess disease extent (head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; and genitals 1%). It evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss in the last 72 hours on visual analogue scales (VAS) of 0 to 10 where 0 is no itch or sleep loss and 10 is worst imaginable itch or sleep loss. These 3 aspects: extent of disease, disease severity, and subjective symptoms combine to give a score between 0(no disease) and 103 (severe disease). Higher scores indicate greater severity.Non-responder imputation (NRI) method was used to impute missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving vIGA-AD of 0</measure>
    <time_frame>Week 16</time_frame>
    <description>vIGA-AD measures participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis-disease extent and clinical signs-by scoring the extent of disease(percentage of skin affected: 0= 0%;1 =1-9%; 2 =10-29%;3 = 30-49%;4 = 50-69%;5 = 70-89%;6 = 90-100%) and the severity of 4 clinical signs (erythema,edema/papulation,excoriation,and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 =mild; 2 = moderate; 3=severe) at 4 body sites(head and neck,trunk,upper limbs,and lower limbs).Half scores are allowed.Each body site will have a score that ranges from 0 to 72,and the final EASI score will be obtained by weight-averaging these 4 scores.Hence,the final EASI score will range from 0 to 72(severe) for each time point.Higher scores indicate greater severity.Least Squares Mean(LS Means) were calculated using mixed model repeated measures(MMRM) with treatment,region, baseline disease severity,visit,treatment-by-visit-interaction,baseline and baseline-by-visit-interaction as fixed effects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in SCORAD</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>The SCORAD index uses the rule of nines to assess disease extent (head and neck 9%;upper limbs 9% each;lower limbs 18% each;anterior trunk 18%;back 18%;and genitals 1%).It evaluates 6 clinical characteristics to determine disease severity: (1)erythema,(2)edema/papulation, (3)oozing/crusts,(4) excoriation,(5) lichenification, and (6) dryness on a scale of 0 to 3(0=absence,1=mild,2=moderate,3=severe).The SCORAD index also assesses subjective symptoms of pruritus and sleep loss in the last 72 hours on visual analogue scales(VAS) of 0 to 10 where 0 is no itch or sleep loss and 10 is worst imaginable itch or sleep loss.These 3 aspects: extent of disease,disease severity,and subjective symptoms combine to give a score between 0(no disease) and 103(severe disease).Higher scores indicate greater severity. LS Means were calculated using a MMRM model with treatment,region,baseline disease severity,visit, treatment-by-visit-interaction,baseline and baseline-by-visit-interaction as fixed effects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving vIGA-AD of 0 or 1 With a &gt;=2-point Improvement at Week 52</measure>
    <time_frame>Week 52</time_frame>
    <description>vIGA-AD measures participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a Steady State (AUCτ,ss) of LY3375880</measure>
    <time_frame>Induction Period: Pre-dose, Day 0, Day 7, Day 14, Day 28, Day 56, Day 112 Post-dose; Maintenance Period:Predose, Day 168; Day 252, Day 364 Post-dose</time_frame>
    <description>Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a steady state (AUCτ,ss) of LY3375880. The PK model was fit using all quantifiable concentrations that were collected in the study (i.e., from the induction and maintenance periods).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">136</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>50 mg LY3375880</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Induction Period:&#xD;
Participants received 50 mg LY3375880 administered SC Q4W.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>150 mg LY3375880</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Induction Period:&#xD;
Participants received 150 mg LY3375880 administered SC Q4W.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>600 mg LY3375880</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Induction Period:&#xD;
Participants received 600 mg LY3375880 administered SC Q4W.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Induction Period:&#xD;
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY3375880</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>150 mg LY3375880</arm_group_label>
    <arm_group_label>50 mg LY3375880</arm_group_label>
    <arm_group_label>600 mg LY3375880</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must have diagnosis of AD &gt;= 12 months according to the American Academy&#xD;
             of Dermatology criteria.&#xD;
&#xD;
          -  Participants must have moderate to severe AD at screening and randomization.&#xD;
&#xD;
          -  Participants must have inadequate response to topical medications within 6 months of&#xD;
             screening (or history of intolerance).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants must not have concurrent treatment with topical or systemic treatments&#xD;
             for AD.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tien Q. Nguyen, MD inc. DBA 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>Dermatology Research Associates</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quest Dermatology Research</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Integrative Skin Science and Research</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arlington Dermatology</name>
      <address>
        <city>Rolling Meadows</city>
        <state>Illinois</state>
        <zip>60008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The South Bend Clinic</name>
      <address>
        <city>South Bend</city>
        <state>Indiana</state>
        <zip>46617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology and Skin Cancer Specialists</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ActivMed Practices &amp; Research, Inc</name>
      <address>
        <city>Portsmouth</city>
        <state>New Hampshire</state>
        <zip>03801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Plastic Surgery and Dermatology</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Wilmington, LLC</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28411</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hightower Clinical Trial Services</name>
      <address>
        <city>Norman</city>
        <state>Oklahoma</state>
        <zip>73072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Dermatology and Research Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Partners LLC</name>
      <address>
        <city>Johnston</city>
        <state>Rhode Island</state>
        <zip>02919</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Studies</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DOM- Centro de Reumatologia</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>1111</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigaciones Metabólicas (CINME)</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1027AAP</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Buenos Aires Skin</name>
      <address>
        <city>Ciudad Autonoma Buenos Aires</city>
        <zip>C1055AA0</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Neumonología y Dermatología</name>
      <address>
        <city>Ciudad Autonoma Buenos Aires</city>
        <zip>C1425BEA</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Psoriahue Medicina Interdisciplinaria</name>
      <address>
        <city>Ciudad Autonoma Buenos Aires</city>
        <zip>C1425DKG</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parra Dermatología</name>
      <address>
        <city>Mendoza</city>
        <zip>5500</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Medico Privado de Reumatologia</name>
      <address>
        <city>Tucuman</city>
        <zip>T4000AXL</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Graz</name>
      <address>
        <city>Graz</city>
        <state>Steiermark</state>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LKH Feldkirch</name>
      <address>
        <city>Feldkirch</city>
        <state>Vorarlberg</state>
        <zip>6807</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sozialmed. Zentrum Ost - Donauspital</name>
      <address>
        <city>Wien</city>
        <zip>1220</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Guenther Dermatology Research Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 3H7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clintrial, s.r.o.</name>
      <address>
        <city>Praha 10</city>
        <state>Hl. M. Praha</state>
        <zip>100 00</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>CHU de Nice Hopital de L'Archet</name>
      <address>
        <city>Nice cedex 3</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatologikum Hamburg</name>
      <address>
        <city>Hamburg</city>
        <zip>20354</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TFS Trial Form Support GmbH</name>
      <address>
        <city>Hamburg</city>
        <zip>20537</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oroshaza Varosi Onkormanyzat Korhaza</name>
      <address>
        <city>Oroshaza</city>
        <state>Bekes</state>
        <zip>5900-H</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergo-Derm Bakos Kft</name>
      <address>
        <city>Szolnok</city>
        <state>Jasz-Nagykun-Szolnok</state>
        <zip>5000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNO Medical Trials Kft.</name>
      <address>
        <city>Budapest</city>
        <zip>1135</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedMare Bt</name>
      <address>
        <city>Veszprem</city>
        <zip>8200</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico di Tor Vergata</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polic.Umberto I -Univ. La Sapienza</name>
      <address>
        <city>Roma</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yasumoto Dermatology Clinic</name>
      <address>
        <city>Chikushino</city>
        <state>Fukuoka</state>
        <zip>818 0083</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takagi Dermatological Clinic</name>
      <address>
        <city>Obihiro</city>
        <state>Hokkaido</state>
        <zip>080-0013</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobe University Hospital</name>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>650-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meiwa Hospital</name>
      <address>
        <city>Nishinomiya</city>
        <state>Hyogo</state>
        <zip>663-8186</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyoto Prefectural University of Medicine</name>
      <address>
        <city>Kyoto-shi</city>
        <state>Kyoto</state>
        <zip>602-8566</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oita University Hospital</name>
      <address>
        <city>Yufu-shi</city>
        <state>Oita</state>
        <zip>8795593</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kume Clinic</name>
      <address>
        <city>Nishi-ku Sakai-shi</city>
        <state>Osaka</state>
        <zip>593-8324</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dokkyo Medical University Saitama Medical Center</name>
      <address>
        <city>Koshigaya</city>
        <state>Saitama</state>
        <zip>343 8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sumire Dermatology Clinic</name>
      <address>
        <city>Edogawa-ku</city>
        <state>Tokyo</state>
        <zip>133-0057</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Matsuda Tomoko Dematological Clinic</name>
      <address>
        <city>Fukuoka</city>
        <zip>819 0167</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grupo Medico Camino S.C.</name>
      <address>
        <city>México City</city>
        <state>Distrito Federal</state>
        <zip>03310</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Derma Norte del Bajío, S.C.</name>
      <address>
        <city>Aguascalientes</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Office of Dr. Samuel Sanchez PSC</name>
      <address>
        <city>Caguas</city>
        <zip>00727</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Office of Dr. Alma M. Cruz</name>
      <address>
        <city>Carolina</city>
        <zip>00985</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ponce School of Medicine CAIMED Center</name>
      <address>
        <city>Ponce</city>
        <zip>00716</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Puerto Rico, Inc.</name>
      <address>
        <city>San Juan</city>
        <zip>00909</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GCM Medical Group PSC</name>
      <address>
        <city>San Juan</city>
        <zip>00917</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de Bellvitge</name>
      <address>
        <city>L'Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universitaria De Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universidad De Navarra</name>
      <address>
        <city>Madrid</city>
        <zip>28027</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Austria</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Mexico</country>
    <country>Puerto Rico</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trials.lillytrialguide.com/en-US/trial/4hXeeEjeZhqtnDW4onAZx3#?postal=</url>
    <description>A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis</description>
  </link>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <results_first_submitted>February 12, 2021</results_first_submitted>
  <results_first_submitted_qc>March 24, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 20, 2021</results_first_posted>
  <last_update_submitted>March 24, 2021</last_update_submitted>
  <last_update_submitted_qc>March 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>eczema</keyword>
  <keyword>atopic eczema</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>Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.</ipd_time_frame>
    <ipd_access_criteria>A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.</ipd_access_criteria>
    <ipd_url>http://www.clinicalstudydatarequest.com</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>July 25, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT03831191/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>November 27, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT03831191/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Responders are participants who achieved a 50% reduction in the Eczema Area and Severity Index score [EASI-50] response, regardless of whether rescue therapy had been initiated during induction period. Participants did not receive 300 mg because the trial was stopped early.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Induction Period:&#xD;
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).</description>
        </group>
        <group group_id="P2">
          <title>50 mg LY3375880</title>
          <description>Induction Period:&#xD;
Participants received 50 milligrams (mg) LY3375880 administered SC Q4W.</description>
        </group>
        <group group_id="P3">
          <title>150 mg LY3375880</title>
          <description>Induction Period:&#xD;
Participants received 150 mg LY3375880 administered SC Q4W.</description>
        </group>
        <group group_id="P4">
          <title>600 mg LY3375880</title>
          <description>Induction Period:&#xD;
Participants received 600 mg LY3375880 administered SC Q4W.</description>
        </group>
        <group group_id="P5">
          <title>Placebo Responder to Placebo/300 mg LY3375880</title>
          <description>Maintenance Period:&#xD;
Participants received placebo administered SC Q4W until loss of response then 300 mg LY3375880 SC Q4W .&#xD;
Participants had received placebo SC Q4W during the induction period.</description>
        </group>
        <group group_id="P6">
          <title>Placebo Non-Responder to 300 mg LY3375880</title>
          <description>Maintenance Period:&#xD;
Participants received 300 mg LY3375880 administered SC Q4W.&#xD;
Participants had received placebo SC Q4W during the induction period.</description>
        </group>
        <group group_id="P7">
          <title>50 mg Responder to Placebo/50 mg LY3375880</title>
          <description>Maintenance Period:&#xD;
Participants received placebo administered SC Q4W until loss of response then 50 mg LY3375880 SC Q4W.&#xD;
Participants had received 50 mg LY3375880 SC Q4W during the induction period.</description>
        </group>
        <group group_id="P8">
          <title>50 mg LY3375880 Responder to 50 mg LY3375880</title>
          <description>Maintenance Period:&#xD;
Participants received 50 mg LY3375880 administered SC Q4W.&#xD;
Participants had received 50 mg LY3375880 SC Q4W during the induction period.</description>
        </group>
        <group group_id="P9">
          <title>50 mg LY3375880 Non-Responder to 150 mg LY3375880</title>
          <description>Maintenance Period:&#xD;
Participants received 150 mg LY3375880 administered SC Q4W.&#xD;
Participants had received 50 mg LY3375880 SC Q4W during the induction period.</description>
        </group>
        <group group_id="P10">
          <title>150 mg Responder to Placebo/150 mg LY3375880</title>
          <description>Maintenance Period:&#xD;
Participants received placebo administered SC Q4W until loss of response then 150 mg LY3375880 SC Q4W.&#xD;
Participants had received 150 mg LY3375880 SC Q4W during the induction period.</description>
        </group>
        <group group_id="P11">
          <title>150 mg LY3375880 Responder to 150 mg LY3375880</title>
          <description>Maintenance Period:&#xD;
Participants received 150 mg LY3375880 administered SC Q4W.&#xD;
Participants had received 150 mg LY3375880 SC Q4W during the induction period.</description>
        </group>
        <group group_id="P12">
          <title>150 mg LY3375880 Non-Responder to 300 mg LY3375880</title>
          <description>Maintenance Period:&#xD;
Participants received 300 mg LY3375880 administered SC Q4W.&#xD;
Participants had received 150 mg LY3375880 SC Q4W during the induction period.</description>
        </group>
        <group group_id="P13">
          <title>600 mg Responder to Placebo/600 mg LY3375880</title>
          <description>Maintenance Period:&#xD;
Participants received placebo administered SC Q4W until loss of response then 600 mg LY3375880 SC Q4W.&#xD;
Participants had received 600 mg LY3375880 SC Q4W during the induction period.</description>
        </group>
        <group group_id="P14">
          <title>600 mg LY3375880 Responder to 600 mg LY3375880</title>
          <description>Maintenance Period:&#xD;
Participants received 600 mg LY3375880 administered SC Q4W.&#xD;
Participants had received 600 mg LY3375880 SC Q4W during the induction period.</description>
        </group>
        <group group_id="P15">
          <title>600 mg LY3375880 Non-Responder to 600 mg LY3375880</title>
          <description>Maintenance Period:&#xD;
Participants received 600 mg LY3375880 administered SC Q4W.&#xD;
Participants had received 600 mg LY3375880 SC Q4W during the induction period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Induction Period (16 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="35"/>
                <participants group_id="P3" count="34"/>
                <participants group_id="P4" count="34"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least One Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="35"/>
                <participants group_id="P3" count="34"/>
                <participants group_id="P4" count="33"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="11"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="21"/>
                <participants group_id="P4" count="23"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="13"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Maintenance Period (36 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0">Participants were assigned to this arm during induction period.</participants>
                <participants group_id="P2" count="0">Participants were assigned to this arm during induction period.</participants>
                <participants group_id="P3" count="0">Participants were assigned to this arm during induction period.</participants>
                <participants group_id="P4" count="0">Participants were assigned to this arm during induction period.</participants>
                <participants group_id="P5" count="4">Participants were assigned to this arm during maintenance period.</participants>
                <participants group_id="P6" count="5">Participants were assigned to this arm during maintenance period.</participants>
                <participants group_id="P7" count="2">Participants were assigned to this arm during maintenance period.</participants>
                <participants group_id="P8" count="4">Participants were assigned to this arm during maintenance period.</participants>
                <participants group_id="P9" count="8">Participants were assigned to this arm during maintenance period.</participants>
                <participants group_id="P10" count="1">Participants were assigned to this arm during maintenance period.</participants>
                <participants group_id="P11" count="4">Participants were assigned to this arm during maintenance period.</participants>
                <participants group_id="P12" count="8">Participants were assigned to this arm during maintenance period.</participants>
                <participants group_id="P13" count="1">Participants were assigned to this arm during maintenance period.</participants>
                <participants group_id="P14" count="1">Participants were assigned to this arm during maintenance period.</participants>
                <participants group_id="P15" count="9">Participants were assigned to this arm during maintenance period.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="1"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="4"/>
                <participants group_id="P9" count="8"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="4"/>
                <participants group_id="P12" count="7"/>
                <participants group_id="P13" count="1"/>
                <participants group_id="P14" count="1"/>
                <participants group_id="P15" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="4"/>
                <participants group_id="P9" count="8"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="4"/>
                <participants group_id="P12" count="7"/>
                <participants group_id="P13" count="1"/>
                <participants group_id="P14" count="1"/>
                <participants group_id="P15" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Post-Treatment Follow-Up Period(8 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0">No participant entered the post follow-up period.</participants>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Induction Period:&#xD;
Participants received placebo administered SC Q4W.</description>
        </group>
        <group group_id="B2">
          <title>50 mg LY3375880</title>
          <description>Induction Period:&#xD;
Participants received 50 mg LY3375880 administered SC Q4W.</description>
        </group>
        <group group_id="B3">
          <title>150 mg LY3375880</title>
          <description>Induction Period:&#xD;
Participants received 150 mg LY3375880 administered SC Q4W.</description>
        </group>
        <group group_id="B4">
          <title>600 mg LY3375880</title>
          <description>Induction Period:&#xD;
Participants received 600 mg LY3375880 administered SC Q4W.</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="33"/>
            <count group_id="B2" value="35"/>
            <count group_id="B3" value="34"/>
            <count group_id="B4" value="34"/>
            <count group_id="B5" value="136"/>
          </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="37.00" spread="14.98"/>
                    <measurement group_id="B2" value="37.70" spread="16.00"/>
                    <measurement group_id="B3" value="39.50" spread="13.94"/>
                    <measurement group_id="B4" value="36.80" spread="13.84"/>
                    <measurement group_id="B5" value="37.80" spread="14.60"/>
                  </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="11"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="78"/>
                  </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="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="47"/>
                  </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>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Argentina</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving Validated Investigator's Global Assessment for AD (vIGA-AD) of 0 or 1 With a ≥2 Point Improvement</title>
        <description>vIGA-AD measures participants' overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity.The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.</description>
        <time_frame>Week 16</time_frame>
        <population>Induction Period: All randomized participants who completed or discontinued the study prior to study termination by the sponsor.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Induction Period:&#xD;
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).</description>
          </group>
          <group group_id="O2">
            <title>50 mg LY3375880</title>
            <description>Induction Period:&#xD;
Participants received 50 mg LY3375880 administered SC Q4W.</description>
          </group>
          <group group_id="O3">
            <title>150 mg LY3375880</title>
            <description>Induction Period:&#xD;
Participants received 150 mg LY3375880 administered SC Q4W.</description>
          </group>
          <group group_id="O4">
            <title>600 mg LY3375880</title>
            <description>Induction Period:&#xD;
Participants received 600 mg LY3375880 administered SC Q4W.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Validated Investigator's Global Assessment for AD (vIGA-AD) of 0 or 1 With a ≥2 Point Improvement</title>
          <description>vIGA-AD measures participants' overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity.The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.</description>
          <population>Induction Period: All randomized participants who completed or discontinued the study prior to study termination by the sponsor.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5" lower_limit="2.7" upper_limit="28.9"/>
                    <measurement group_id="O2" value="5.0" lower_limit="0.9" upper_limit="23.6"/>
                    <measurement group_id="O3" value="5.9" lower_limit="1.0" upper_limit="27.0"/>
                    <measurement group_id="O4" value="4.8" lower_limit="0.8" upper_limit="22.7"/>
                  </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>0.638</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.04</ci_lower_limit>
            <ci_upper_limit>6.81</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>0.773</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.05</ci_lower_limit>
            <ci_upper_limit>8.76</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>0.671</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.05</ci_lower_limit>
            <ci_upper_limit>7.26</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75)</title>
        <description>EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs - by scoring the extent of disease (percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. Each body site will have a score that ranges from 0 to 72, and the final EASI score will be obtained by weight-averaging these 4 scores. Hence, the final EASI score will range from 0 to 72 (severe) for each time point. A higher score represented greater disease severity.The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. Non-responder imputation (NRI) method was used to impute missing data.</description>
        <time_frame>Week 16</time_frame>
        <population>Induction Period: All randomized participants who completed or discontinued the study prior to study termination by the sponsor.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Induction Period:&#xD;
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).</description>
          </group>
          <group group_id="O2">
            <title>50 mg LY3375880</title>
            <description>Induction Period:&#xD;
Participants received 50 mg LY3375880 administered SC Q4W.</description>
          </group>
          <group group_id="O3">
            <title>150 mg LY3375880</title>
            <description>Induction Period:&#xD;
Participants received 150 mg LY3375880 administered SC Q4W.</description>
          </group>
          <group group_id="O4">
            <title>600 mg LY3375880</title>
            <description>Induction Period:&#xD;
Participants received 600 mg LY3375880 administered SC Q4W.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75)</title>
          <description>EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs - by scoring the extent of disease (percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. Each body site will have a score that ranges from 0 to 72, and the final EASI score will be obtained by weight-averaging these 4 scores. Hence, the final EASI score will range from 0 to 72 (severe) for each time point. A higher score represented greater disease severity.The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. Non-responder imputation (NRI) method was used to impute missing data.</description>
          <population>Induction Period: All randomized participants who completed or discontinued the study prior to study termination by the sponsor.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.0" lower_limit="7.7" upper_limit="40.0"/>
                    <measurement group_id="O2" value="15.0" lower_limit="5.2" upper_limit="36.0"/>
                    <measurement group_id="O3" value="23.5" lower_limit="9.6" upper_limit="47.3"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="15.5"/>
                  </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>&gt;0.999</p_value>
            <method>Fisher Exact</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-4.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27.2</ci_lower_limit>
            <ci_upper_limit>19.9</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>&gt;0.999</p_value>
            <method>Fisher Exact</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>4.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-20.7</ci_lower_limit>
            <ci_upper_limit>30.8</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>0.107</p_value>
            <method>Fisher Exact</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-19.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-40.0</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD-75)</title>
        <description>The SCORAD index uses the rule of nines to assess disease extent (head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; and genitals 1%). It evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss in the last 72 hours on visual analogue scales (VAS) of 0 to 10 where 0 is no itch or sleep loss and 10 is worst imaginable itch or sleep loss. These 3 aspects: extent of disease, disease severity, and subjective symptoms combine to give a score between 0(no disease) and 103 (severe disease). Higher scores indicate greater severity.Non-responder imputation (NRI) method was used to impute missing data.</description>
        <time_frame>Week 16</time_frame>
        <population>Induction Period: All randomized participants who completed or discontinued the study prior to study termination by the sponsor.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Induction Period:&#xD;
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).</description>
          </group>
          <group group_id="O2">
            <title>50 mg LY3375880</title>
            <description>Induction Period:&#xD;
Participants received 50 mg LY3375880 administered SC Q4W.</description>
          </group>
          <group group_id="O3">
            <title>150 mg LY3375880</title>
            <description>Induction Period:&#xD;
Participants received 150 mg LY3375880 administered SC Q4W.</description>
          </group>
          <group group_id="O4">
            <title>600 mg LY3375880</title>
            <description>Induction Period:&#xD;
Participants received 600 mg LY3375880 administered SC Q4W.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD-75)</title>
          <description>The SCORAD index uses the rule of nines to assess disease extent (head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; and genitals 1%). It evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss in the last 72 hours on visual analogue scales (VAS) of 0 to 10 where 0 is no itch or sleep loss and 10 is worst imaginable itch or sleep loss. These 3 aspects: extent of disease, disease severity, and subjective symptoms combine to give a score between 0(no disease) and 103 (severe disease). Higher scores indicate greater severity.Non-responder imputation (NRI) method was used to impute missing data.</description>
          <population>Induction Period: All randomized participants who completed or discontinued the study prior to study termination by the sponsor.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" lower_limit="0.8" upper_limit="22.7"/>
                    <measurement group_id="O2" value="5.0" lower_limit="0.9" upper_limit="23.6"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="18.4"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="15.5"/>
                  </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>&gt;0.999</p_value>
            <method>Fisher Exact</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.1</ci_lower_limit>
            <ci_upper_limit>19.3</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>&gt;0.999</p_value>
            <method>Fisher Exact</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-4.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-22.7</ci_lower_limit>
            <ci_upper_limit>14.1</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>&gt;0.999</p_value>
            <method>Fisher Exact</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-4.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-22.7</ci_lower_limit>
            <ci_upper_limit>11.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving vIGA-AD of 0</title>
        <description>vIGA-AD measures participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.</description>
        <time_frame>Week 16</time_frame>
        <population>Induction Period: All randomized participants who completed or discontinued the study prior to study termination by the sponsor.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Induction Period:&#xD;
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).</description>
          </group>
          <group group_id="O2">
            <title>50 mg LY3375880</title>
            <description>Induction Period:&#xD;
Participants received 50 mg LY3375880 administered SC Q4W.</description>
          </group>
          <group group_id="O3">
            <title>150 mg LY3375880</title>
            <description>Induction Period:&#xD;
Participants received 150 mg LY3375880 administered SC Q4W.</description>
          </group>
          <group group_id="O4">
            <title>600 mg LY3375880</title>
            <description>Induction Period:&#xD;
Participants received 600 mg LY3375880 administered SC Q4W.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving vIGA-AD of 0</title>
          <description>vIGA-AD measures participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.</description>
          <population>Induction Period: All randomized participants who completed or discontinued the study prior to study termination by the sponsor.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                  </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>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0</ci_lower_limit>
            <ci_upper_limit>0.0</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>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0</ci_lower_limit>
            <ci_upper_limit>0.0</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>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score</title>
        <description>EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis-disease extent and clinical signs-by scoring the extent of disease(percentage of skin affected: 0= 0%;1 =1-9%; 2 =10-29%;3 = 30-49%;4 = 50-69%;5 = 70-89%;6 = 90-100%) and the severity of 4 clinical signs (erythema,edema/papulation,excoriation,and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 =mild; 2 = moderate; 3=severe) at 4 body sites(head and neck,trunk,upper limbs,and lower limbs).Half scores are allowed.Each body site will have a score that ranges from 0 to 72,and the final EASI score will be obtained by weight-averaging these 4 scores.Hence,the final EASI score will range from 0 to 72(severe) for each time point.Higher scores indicate greater severity.Least Squares Mean(LS Means) were calculated using mixed model repeated measures(MMRM) with treatment,region, baseline disease severity,visit,treatment-by-visit-interaction,baseline and baseline-by-visit-interaction as fixed effects.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>Induction Period: All randomized participants who had a baseline and at least one post-baseline EASI value.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Induction Period:&#xD;
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).</description>
          </group>
          <group group_id="O2">
            <title>50 mg LY3375880</title>
            <description>Induction Period:&#xD;
Participants received 50 mg LY3375880 administered SC Q4W.</description>
          </group>
          <group group_id="O3">
            <title>150 mg LY3375880</title>
            <description>Induction Period:&#xD;
Participants received 150 mg LY3375880 administered SC Q4W.</description>
          </group>
          <group group_id="O4">
            <title>600 mg LY3375880</title>
            <description>Induction Period:&#xD;
Participants received 600 mg LY3375880 administered SC Q4W.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score</title>
          <description>EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis-disease extent and clinical signs-by scoring the extent of disease(percentage of skin affected: 0= 0%;1 =1-9%; 2 =10-29%;3 = 30-49%;4 = 50-69%;5 = 70-89%;6 = 90-100%) and the severity of 4 clinical signs (erythema,edema/papulation,excoriation,and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 =mild; 2 = moderate; 3=severe) at 4 body sites(head and neck,trunk,upper limbs,and lower limbs).Half scores are allowed.Each body site will have a score that ranges from 0 to 72,and the final EASI score will be obtained by weight-averaging these 4 scores.Hence,the final EASI score will range from 0 to 72(severe) for each time point.Higher scores indicate greater severity.Least Squares Mean(LS Means) were calculated using mixed model repeated measures(MMRM) with treatment,region, baseline disease severity,visit,treatment-by-visit-interaction,baseline and baseline-by-visit-interaction as fixed effects.</description>
          <population>Induction Period: All randomized participants who had a baseline and at least one post-baseline EASI value.</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="6"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.45" spread="4.68"/>
                    <measurement group_id="O2" value="-4.90" spread="4.30"/>
                    <measurement group_id="O3" value="-5.89" spread="4.55"/>
                    <measurement group_id="O4" value="-7.87" spread="4.02"/>
                  </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>0.310</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Median Difference (Net)</param_type>
            <param_value>6.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.36</ci_lower_limit>
            <ci_upper_limit>19.45</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>0.393</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>5.56</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.50</ci_lower_limit>
            <ci_upper_limit>18.63</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>0.564</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>3.59</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.91</ci_lower_limit>
            <ci_upper_limit>16.08</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in SCORAD</title>
        <description>The SCORAD index uses the rule of nines to assess disease extent (head and neck 9%;upper limbs 9% each;lower limbs 18% each;anterior trunk 18%;back 18%;and genitals 1%).It evaluates 6 clinical characteristics to determine disease severity: (1)erythema,(2)edema/papulation, (3)oozing/crusts,(4) excoriation,(5) lichenification, and (6) dryness on a scale of 0 to 3(0=absence,1=mild,2=moderate,3=severe).The SCORAD index also assesses subjective symptoms of pruritus and sleep loss in the last 72 hours on visual analogue scales(VAS) of 0 to 10 where 0 is no itch or sleep loss and 10 is worst imaginable itch or sleep loss.These 3 aspects: extent of disease,disease severity,and subjective symptoms combine to give a score between 0(no disease) and 103(severe disease).Higher scores indicate greater severity. LS Means were calculated using a MMRM model with treatment,region,baseline disease severity,visit, treatment-by-visit-interaction,baseline and baseline-by-visit-interaction as fixed effects.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>Induction Period: All randomized participants who had a baseline and at least one post-baseline SCORAD value.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Induction Period:&#xD;
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).</description>
          </group>
          <group group_id="O2">
            <title>50 mg LY3375880</title>
            <description>Induction Period:&#xD;
Participants received 50 mg LY3375880 administered SC Q4W.</description>
          </group>
          <group group_id="O3">
            <title>150 mg LY3375880</title>
            <description>Induction Period:&#xD;
Participants received 150 mg LY3375880 administered SC Q4W.</description>
          </group>
          <group group_id="O4">
            <title>600 mg LY3375880</title>
            <description>Induction Period:&#xD;
Participants received 600 mg LY3375880 administered SC Q4W.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in SCORAD</title>
          <description>The SCORAD index uses the rule of nines to assess disease extent (head and neck 9%;upper limbs 9% each;lower limbs 18% each;anterior trunk 18%;back 18%;and genitals 1%).It evaluates 6 clinical characteristics to determine disease severity: (1)erythema,(2)edema/papulation, (3)oozing/crusts,(4) excoriation,(5) lichenification, and (6) dryness on a scale of 0 to 3(0=absence,1=mild,2=moderate,3=severe).The SCORAD index also assesses subjective symptoms of pruritus and sleep loss in the last 72 hours on visual analogue scales(VAS) of 0 to 10 where 0 is no itch or sleep loss and 10 is worst imaginable itch or sleep loss.These 3 aspects: extent of disease,disease severity,and subjective symptoms combine to give a score between 0(no disease) and 103(severe disease).Higher scores indicate greater severity. LS Means were calculated using a MMRM model with treatment,region,baseline disease severity,visit, treatment-by-visit-interaction,baseline and baseline-by-visit-interaction as fixed effects.</description>
          <population>Induction Period: All randomized participants who had a baseline and at least one post-baseline SCORAD value.</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="7"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.27" spread="5.92"/>
                    <measurement group_id="O2" value="-11.66" spread="5.72"/>
                    <measurement group_id="O3" value="-16.94" spread="6.03"/>
                    <measurement group_id="O4" value="-12.75" spread="5.3"/>
                  </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>0.356</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>7.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.82</ci_lower_limit>
            <ci_upper_limit>24.05</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>0.783</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>2.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.64</ci_lower_limit>
            <ci_upper_limit>19.30</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>0.414</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>6.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.40</ci_lower_limit>
            <ci_upper_limit>22.43</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving vIGA-AD of 0 or 1 With a &gt;=2-point Improvement at Week 52</title>
        <description>vIGA-AD measures participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.</description>
        <time_frame>Week 52</time_frame>
        <population>Maintenance Period: All randomized participants who had a &gt;=2-point improvement at Week 52.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).</description>
          </group>
          <group group_id="O2">
            <title>50 mg LY3375880</title>
            <description>Participants received 50 mg LY3375880 administered SC Q4W.</description>
          </group>
          <group group_id="O3">
            <title>150 mg LY3375880</title>
            <description>Participants received 150 mg LY3375880 administered SC Q4W.</description>
          </group>
          <group group_id="O4">
            <title>300 mg LY3375880</title>
            <description>Participants received 300 mg LY3375880 administered SC Q4W.</description>
          </group>
          <group group_id="O5">
            <title>600 mg LY3375880</title>
            <description>Participants received 600 mg LY3375880 administered SC Q4W.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving vIGA-AD of 0 or 1 With a &gt;=2-point Improvement at Week 52</title>
          <description>vIGA-AD measures participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.</description>
          <population>Maintenance Period: All randomized participants who had a &gt;=2-point improvement at Week 52.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="32.4"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="49.0"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="24.2"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="22.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="27.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a Steady State (AUCτ,ss) of LY3375880</title>
        <description>Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a steady state (AUCτ,ss) of LY3375880. The PK model was fit using all quantifiable concentrations that were collected in the study (i.e., from the induction and maintenance periods).</description>
        <time_frame>Induction Period: Pre-dose, Day 0, Day 7, Day 14, Day 28, Day 56, Day 112 Post-dose; Maintenance Period:Predose, Day 168; Day 252, Day 364 Post-dose</time_frame>
        <population>All randomized participants who received LY3375880 in induction and maintenance period who had evaluable PK data. Participants did not received 300 mg because the trial was stopped early.</population>
        <group_list>
          <group group_id="O1">
            <title>50 mg LY3375880</title>
            <description>Participants received 50 mg LY3375880 administered SC Q4W.</description>
          </group>
          <group group_id="O2">
            <title>150 mg LY3375880</title>
            <description>Participants received 150 mg LY3375880 administered SC Q4W.</description>
          </group>
          <group group_id="O3">
            <title>600 mg LY3375880</title>
            <description>Participants received 600 mg LY3375880 administered SC Q4W.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a Steady State (AUCτ,ss) of LY3375880</title>
          <description>Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a steady state (AUCτ,ss) of LY3375880. The PK model was fit using all quantifiable concentrations that were collected in the study (i.e., from the induction and maintenance periods).</description>
          <population>All randomized participants who received LY3375880 in induction and maintenance period who had evaluable PK data. Participants did not received 300 mg because the trial was stopped early.</population>
          <units>Nanograms*hour per millilitre (ng*h/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4450" spread="80.2"/>
                    <measurement group_id="O2" value="11200" spread="41.9"/>
                    <measurement group_id="O3" value="49000" spread="40.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline Up To 45 Weeks</time_frame>
      <desc>All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Induction Period:&#xD;
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).</description>
        </group>
        <group group_id="E2">
          <title>50 mg LY3375880</title>
          <description>Induction Period:&#xD;
Participants received 50 mg LY3375880 administered SC Q4W.</description>
        </group>
        <group group_id="E3">
          <title>150 mg LY3375880</title>
          <description>Induction Period:&#xD;
Participants received 150 mg LY3375880 administered SC Q4W.</description>
        </group>
        <group group_id="E4">
          <title>600 mg LY3375880</title>
          <description>Induction Period:&#xD;
Participants received 600 mg LY3375880 administered SC Q4W.</description>
        </group>
        <group group_id="E5">
          <title>Placebo Responder to Placebo/300 mg LY3375880</title>
          <description>Maintenance Period:&#xD;
Participants received placebo administered SC Q4W until loss of response then 300 mg LY3375880 SC Q4W .&#xD;
Participants had received placebo SC Q4W during the induction period.</description>
        </group>
        <group group_id="E6">
          <title>Placebo Non-Responder to 300 mg LY3375880</title>
          <description>Maintenance Period:&#xD;
Participants received 300 mg LY3375880 administered SC Q4W.&#xD;
Participants had received placebo SC Q4W during the induction period.</description>
        </group>
        <group group_id="E7">
          <title>50 mg Responder to Placebo/50 mg LY3375880</title>
          <description>Maintenance Period:&#xD;
Participants received placebo administered SC Q4W until loss of response then 50 mg LY3375880 SC Q4W.&#xD;
Participants had received 50 mg LY3375880 SC Q4W during the induction period.</description>
        </group>
        <group group_id="E8">
          <title>50 mg LY3375880 Responder to 50 mg LY3375880</title>
          <description>Maintenance Period:&#xD;
Participants received 50 mg LY3375880 administered SC Q4W.&#xD;
Participants had received 50 mg LY3375880 SC Q4W during the induction period.</description>
        </group>
        <group group_id="E9">
          <title>50 mg LY3375880 Non-Responder to 150 mg LY3375880</title>
          <description>Maintenance Period:&#xD;
Participants received 150 mg LY3375880 administered SC Q4W.&#xD;
Participants had received 50 mg LY3375880 SC Q4W during the induction period.</description>
        </group>
        <group group_id="E10">
          <title>150 mg Responder to Placebo/150 mg LY3375880</title>
          <description>Maintenance Period:&#xD;
Participants received placebo administered SC Q4W until loss of response then 150 mg LY3375880 SC Q4W.&#xD;
Participants had received 150 mg LY3375880 SC Q4W during the induction period.</description>
        </group>
        <group group_id="E11">
          <title>150 mg LY3375880 Responder to 150 mg LY3375880</title>
          <description>Maintenance Period:&#xD;
Participants received 150 mg LY3375880 administered SC Q4W.&#xD;
Participants had received 150 mg LY3375880 SC Q4W during the induction period.</description>
        </group>
        <group group_id="E12">
          <title>150 mg LY3375880 Non-Responder to 300 mg LY3375880</title>
          <description>Maintenance Period:&#xD;
Participants received 300 mg LY3375880 administered SC Q4W.&#xD;
Participants had received 150 mg LY3375880 SC Q4W during the induction period.</description>
        </group>
        <group group_id="E13">
          <title>600 mg Responder to Placebo/600 mg LY3375880</title>
          <description>Maintenance Period:&#xD;
Participants received placebo administered SC Q4W until loss of response then 600 mg LY3375880 SC Q4W.&#xD;
Participants had received 600 mg LY3375880 SC Q4W during the induction period.</description>
        </group>
        <group group_id="E14">
          <title>600 mg LY3375880 Responder to 600 mg LY3375880</title>
          <description>Maintenance Period:&#xD;
Participants received 600 mg LY3375880 administered SC Q4W.&#xD;
Participants had received 600 mg LY3375880 SC Q4W during the induction period.</description>
        </group>
        <group group_id="E15">
          <title>600 mg LY3375880 Non-Responder to 600 mg LY3375880</title>
          <description>Maintenance Period:&#xD;
Participants received 600 mg LY3375880 administered SC Q4W.&#xD;
Participants had received 600 mg LY3375880 SC Q4W during the induction period.</description>
        </group>
        <group group_id="E16">
          <title>LY3375880-50mg-Q4W-Post-Treatment Follow-Up Period</title>
          <description>Follow-up: participants did not receive drug during the follow-up period.</description>
        </group>
        <group group_id="E17">
          <title>LY3375880-150mg-Q4W-Post-Treatment Follow-Up Period</title>
          <description>Follow-up: participants did not receive drug during the follow-up period.</description>
        </group>
        <group group_id="E18">
          <title>LY3375880-600mg-Q4W-Post-Treatment Follow-Up Period</title>
          <description>Follow-up: participants did not receive drug during the follow-up period.</description>
        </group>
        <group group_id="E19">
          <title>Placebo-Post-Treatment Follow-Up Period</title>
          <description>Follow-up: participants did not receive drug during the follow-up period.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.1</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="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </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" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="34"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="33"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E12" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ligament rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Electrocardiogram qt prolonged</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Synovial cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
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                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
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                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
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                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
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                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Menstruation irregular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="13"/>
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                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="3"/>
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                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
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              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
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                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Androgenetic alopecia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pain of skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E13" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E14" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E15" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E16" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E17" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E18" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E19" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </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 only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was terminated for lack of efficacy after an interim analysis was performed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
      <email>ClinicalTrials.gov@lilly.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/NCT03831191
org study id: 17104
secondary id: I9N-MC-FCAB
secondary id: 2018-002401-56
nct id: NCT03831191
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The reason for this study is to see if the study drug LY3375880 is safe and effective in
      adults with moderate-to-severe atopic dermatitis (AD).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants Achieving Validated Investigator's Global Assessment for AD (vIGA-AD) of 0 or 1 With a ≥2 Point Improvement
time frame: Week 16
description: vIGA-AD measures participants' overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity.The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.
measure: Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75)
time frame: Week 16
description: EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs - by scoring the extent of disease (percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. Each body site will have a score that ranges from 0 to 72, and the final EASI score will be obtained by weight-averaging these 4 scores. Hence, the final EASI score will range from 0 to 72 (severe) for each time point. A higher score represented greater disease severity.The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. Non-responder imputation (NRI) method was used to impute missing data.
measure: Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD-75)
time frame: Week 16
description: The SCORAD index uses the rule of nines to assess disease extent (head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; and genitals 1%). It evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss in the last 72 hours on visual analogue scales (VAS) of 0 to 10 where 0 is no itch or sleep loss and 10 is worst imaginable itch or sleep loss. These 3 aspects: extent of disease, disease severity, and subjective symptoms combine to give a score between 0(no disease) and 103 (severe disease). Higher scores indicate greater severity.Non-responder imputation (NRI) method was used to impute missing data.
measure: Percentage of Participants Achieving vIGA-AD of 0
time frame: Week 16
description: vIGA-AD measures participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.
measure: Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score
time frame: Baseline, Week 16
description: EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis-disease extent and clinical signs-by scoring the extent of disease(percentage of skin affected: 0= 0%;1 =1-9%; 2 =10-29%;3 = 30-49%;4 = 50-69%;5 = 70-89%;6 = 90-100%) and the severity of 4 clinical signs (erythema,edema/papulation,excoriation,and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 =mild; 2 = moderate; 3=severe) at 4 body sites(head and neck,trunk,upper limbs,and lower limbs).Half scores are allowed.Each body site will have a score that ranges from 0 to 72,and the final EASI score will be obtained by weight-averaging these 4 scores.Hence,the final EASI score will range from 0 to 72(severe) for each time point.Higher scores indicate greater severity.Least Squares Mean(LS Means) were calculated using mixed model repeated measures(MMRM) with treatment,region, baseline disease severity,visit,treatment-by-visit-interaction,baseline and baseline-by-visit-interaction as fixed effects.
measure: Mean Change From Baseline in SCORAD
time frame: Baseline, Week 16
description: The SCORAD index uses the rule of nines to assess disease extent (head and neck 9%;upper limbs 9% each;lower limbs 18% each;anterior trunk 18%;back 18%;and genitals 1%).It evaluates 6 clinical characteristics to determine disease severity: (1)erythema,(2)edema/papulation, (3)oozing/crusts,(4) excoriation,(5) lichenification, and (6) dryness on a scale of 0 to 3(0=absence,1=mild,2=moderate,3=severe).The SCORAD index also assesses subjective symptoms of pruritus and sleep loss in the last 72 hours on visual analogue scales(VAS) of 0 to 10 where 0 is no itch or sleep loss and 10 is worst imaginable itch or sleep loss.These 3 aspects: extent of disease,disease severity,and subjective symptoms combine to give a score between 0(no disease) and 103(severe disease).Higher scores indicate greater severity. LS Means were calculated using a MMRM model with treatment,region,baseline disease severity,visit, treatment-by-visit-interaction,baseline and baseline-by-visit-interaction as fixed effects.
measure: Percentage of Participants Achieving vIGA-AD of 0 or 1 With a >=2-point Improvement at Week 52
time frame: Week 52
description: vIGA-AD measures participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5 point scale from 0 (clear) to 4 (severe). Higher scores indicate greater severity. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Non-responder imputation (NRI) method was used to impute missing data.
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a Steady State (AUCτ,ss) of LY3375880
time frame: Induction Period: Pre-dose, Day 0, Day 7, Day 14, Day 28, Day 56, Day 112 Post-dose; Maintenance Period:Predose, Day 168; Day 252, Day 364 Post-dose
description: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a steady state (AUCτ,ss) of LY3375880. The PK model was fit using all quantifiable concentrations that were collected in the study (i.e., from the induction and maintenance periods).
arm group label: 50 mg LY3375880
arm group type: Experimental
description: Induction Period:
Participants received 50 mg LY3375880 administered SC Q4W.
arm group label: 150 mg LY3375880
arm group type: Experimental
description: Induction Period:
Participants received 150 mg LY3375880 administered SC Q4W.
arm group label: 600 mg LY3375880
arm group type: Experimental
description: Induction Period:
Participants received 600 mg LY3375880 administered SC Q4W.
arm group label: Placebo
arm group type: Placebo Comparator
description: Induction Period:
Participants received placebo administered subcutaneously (SC) every 4 weeks (Q4W).
intervention type: Drug
intervention name: LY3375880
description: Administered SC
arm group label: 150 mg LY3375880
arm group label: 50 mg LY3375880
arm group label: 600 mg LY3375880
intervention type: Drug
intervention name: Placebo
description: Administered SC
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
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country: Argentina
country: Austria
country: Canada
country: Czechia
country: France
country: Germany
country: Hungary
country: Italy
country: Japan
country: Mexico
country: Puerto Rico
country: Spain
country: United States
url: https://trials.lillytrialguide.com/en-US/trial/4hXeeEjeZhqtnDW4onAZx3#?postal=
description: A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: Yes
ipd description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
ipd access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
ipd url: http://www.clinicalstudydatarequest.com
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated for lack of efficacy after an interim analysis was performed.
point of contact: 