<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/NCT01710358</url>
  </required_header>
  <id_info>
    <org_study_id>13978</org_study_id>
    <secondary_id>I4V-MC-JADV</secondary_id>
    <nct_id>NCT01710358</nct_id>
  </id_info>
  <brief_title>A Study in Moderate to Severe Rheumatoid Arthritis</brief_title>
  <acronym>RA-BEAM</acronym>
  <official_title>A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether baricitinib is superior to placebo in the&#xD;
      treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who&#xD;
      have had an inadequate response to methotrexate (MTX) treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)</measure>
    <time_frame>Week 12</time_frame>
    <description>ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). &quot;ACR20 Responder&quot; is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis timepoint were deemed non-responders.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Modified Total Sharp Score (mTSS)</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing for 44 and 42 joints, with higher scores representing greater damage.&#xD;
The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty (0 [without any difficulty], 1 [with some difficulty], 2 [with much difficulty], and 3 [unable to do]) when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response</measure>
    <time_frame>Week 12, Week 24, Week 52</time_frame>
    <description>ACR50 and ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR50 and ACR70 Responder is a participant who has at least 50% or 70% improvement, respectively, in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP.&#xD;
Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Disease Activity Index (CDAI) Score</measure>
    <time_frame>Baseline, Week 12, Week 24, Week 52</time_frame>
    <description>The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Score ≤3.3</measure>
    <time_frame>Week 12, Week 24, Week 52</time_frame>
    <description>SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission - Boolean Remission</measure>
    <time_frame>Week 12, Week 24, Week 52</time_frame>
    <description>The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median of Individual Participant Mean Duration of Morning Joint Stiffness in the Prior 7 Days as Collected in Electronic Diaries</measure>
    <time_frame>Week 12</time_frame>
    <description>Participants recorded the duration of their morning joint stiffness (MJS) in hours and minutes into electronic diaries daily. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit was calculated. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries</measure>
    <time_frame>Week 12</time_frame>
    <description>Participants rated the severity of their morning joint stiffness by selecting a number from 0 to 10 that best described their overall level of morning joint stiffness from the time they woke up, where 0 represents &quot;no joint stiffness&quot; and 10 represents &quot;joint stiffness as bad as you can imagine&quot;. Participants reported their severity daily in electronic diaries. The average value across the 7 days preceding each visit was calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries</measure>
    <time_frame>Week 12</time_frame>
    <description>Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents &quot;no tiredness&quot; and 10 represents &quot;as bad as you can imagine&quot;. Participants reported their worst tiredness in electronic diaries. The average value across the 7 days preceding each visit is calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Worst Joint Pain NRS in the Prior 7 Days as Collected in Electronic Diaries</measure>
    <time_frame>Week 12</time_frame>
    <description>Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents &quot;no pain&quot; and 10 represents &quot;pain as bad as you can imagine&quot;. Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit was calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores</measure>
    <time_frame>Baseline, Week 12, Week 24, Week 52</time_frame>
    <description>The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (&quot;Not at all&quot;) to 4 (&quot;Very much&quot;) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)</measure>
    <time_frame>Baseline, Week 12, Week 24, Week 52</time_frame>
    <description>The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores</measure>
    <time_frame>Baseline, Week 12, Week 24, Week 52</time_frame>
    <description>European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)</measure>
    <time_frame>Baseline, Week 12, Week 24, Week 52</time_frame>
    <description>A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores</measure>
    <time_frame>Baseline, Week 12, Week 24, Week 52</time_frame>
    <description>The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Joint Space Narrowing (JSN) and Bone Erosion Scores</measure>
    <time_frame>Baseline, Week 24, Week 52</time_frame>
    <description>X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.&#xD;
The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints, with 0 indicating no erosion and the highest score (5 for the hand and 10 for the foot) indicating extensive loss of bone from more than one half of the articulating bone. Erosion scores ranged from 0 (no erosion) to 280 (high erosion).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Population Pharmacokinetics (PK): Peak Concentration at Steady State (Cmax,ss) of Baricitinib</measure>
    <time_frame>Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 12; Week 24; Week 32: Pre-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Population PK: Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib</measure>
    <time_frame>Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 12; Week 24; Week 32: Pre-dose</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1307</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered orally once daily through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.&#xD;
Participants continued to take background methotrexate (MTX) therapy throughout study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Baricitinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.&#xD;
Participants continued to take background methotrexate (MTX) therapy throughout study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adalimumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.&#xD;
Participants continued to take background methotrexate (MTX) therapy throughout study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adalimumab</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Adalimumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Baricitinib</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Baricitinib</arm_group_label>
    <other_name>LY 3009104</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methotrexate</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Adalimumab</arm_group_label>
    <arm_group_label>Baricitinib</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adalimumab Placebo</intervention_name>
    <description>Adalimumab placebo administered SC.</description>
    <arm_group_label>Baricitinib</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Baricitinib Placebo</intervention_name>
    <description>Baricitinib placebo administered orally.</description>
    <arm_group_label>Adalimumab</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a diagnosis of adult-onset Rheumatoid Arthritis (RA) as defined by the American&#xD;
             College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 Criteria&#xD;
             for the Classification of RA&#xD;
&#xD;
          -  Have moderately to severely active RA defined as the presence of at least 6/68 tender&#xD;
             joints and at least 6/66 swollen joints&#xD;
&#xD;
          -  Have a C-reactive protein (CRP) or high-sensitivity C-reactive protein (hsCRP)&#xD;
             measurement ≥6 milligram per Liter (mg/L)&#xD;
&#xD;
          -  Have had regular use of methotrexate (MTX) for at least the 12 weeks prior to study&#xD;
             entry at a dose that is considered acceptable to adequately assess clinical response.&#xD;
&#xD;
          -  Have at least 1 joint erosion in hand, wrist, or foot joints based on radiographic&#xD;
             interpretation by the central reader and be rheumatoid factor or anticyclic&#xD;
             citrullinated peptide (anti-CCP) antibody positive; or have at least 3 joint erosions&#xD;
             in hand, wrist, or foot joints based on radiographic interpretation by the central&#xD;
             reader regardless of rheumatoid factor or anti-CCP antibody status&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are currently receiving corticosteroids at doses &gt;10 mg of prednisone per day (or&#xD;
             equivalent) or have been receiving an unstable dosing regimen of corticosteroids&#xD;
             within 2 weeks of study entry or within 6 weeks of planned randomization&#xD;
&#xD;
          -  Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have&#xD;
             been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or&#xD;
             within 6 weeks of planned randomization&#xD;
&#xD;
          -  Are currently receiving concomitant treatment with MTX, hydroxychloroquine, and&#xD;
             sulfasalazine or combination of any 3 conventional disease-modifying antirheumatic&#xD;
             drugs (cDMARDs)&#xD;
&#xD;
          -  Are currently receiving or have received cDMARDs (eg, gold salts, cyclosporine,&#xD;
             azathioprine, or any other immunosuppressives) other than MTX, hydroxychloroquine (up&#xD;
             to 400 mg/day), or sulfasalazine (up to 3000 mg/day) within 4 weeks prior to study&#xD;
             entry&#xD;
&#xD;
          -  Have received leflunomide in the 12 weeks prior to study entry&#xD;
&#xD;
          -  Have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry&#xD;
&#xD;
          -  Have ever received any biologic disease-modifying antirheumatic drugs (DMARD)&#xD;
&#xD;
          -  Have received interferon therapy within 4 weeks prior to study entry or are&#xD;
             anticipated to require interferon therapy during the study&#xD;
&#xD;
          -  Have received any parenteral corticosteroid administered by intramuscular or&#xD;
             intravenous injection within 2 weeks prior to study entry or within 6 weeks prior to&#xD;
             planned randomization or are anticipated to require parenteral injection of&#xD;
             corticosteroids during the study&#xD;
&#xD;
          -  Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic&#xD;
             acid within 2 weeks prior to study entry or within 6 weeks prior to planned&#xD;
             randomization&#xD;
&#xD;
          -  Have any condition or contraindication for adalimumab that would preclude the&#xD;
             participant from participating in this protocol&#xD;
&#xD;
          -  Have active fibromyalgia that would make it difficult to appropriately assess RA&#xD;
             activity for the purposes of this study&#xD;
&#xD;
          -  Have a diagnosis of any systemic inflammatory condition other than RA such as, but not&#xD;
             limited to, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease,&#xD;
             ulcerative colitis, psoriatic arthritis, active vasculitis or gout(participants with&#xD;
             secondary Sjögren's syndrome are not excluded)&#xD;
&#xD;
          -  Have a diagnosis of Felty's syndrome&#xD;
&#xD;
          -  Have had any major surgery within 8 weeks prior to study entry or will require major&#xD;
             surgery during the study that, in the opinion of the investigator in consultation with&#xD;
             Lilly or its designee, would pose an unacceptable risk to the participant&#xD;
&#xD;
          -  Have experienced any of the following within 12 weeks of study entry: myocardial&#xD;
             infarction, unstable ischemic heart disease, stroke, or New York Heart Association&#xD;
             Stage IV heart failure&#xD;
&#xD;
          -  Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal,&#xD;
             endocrine, hematological, neurological, or neuropsychiatric disorders or any other&#xD;
             serious and/or unstable illness that, in the opinion of the investigator, could&#xD;
             constitute a risk when taking investigational product or could interfere with the&#xD;
             interpretation of data&#xD;
&#xD;
          -  Are largely or wholly incapacitated permitting little or no self-care, such as being&#xD;
             bedridden or confined to a wheelchair&#xD;
&#xD;
          -  have a history of, lymphoproliferative disease; or have signs or symptoms suggestive&#xD;
             of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or&#xD;
             have active primary or recurrent malignant disease; or have been in remission from&#xD;
             clinically significant malignancy for &lt;5 years&#xD;
&#xD;
          -  Have been exposed to a live vaccine within 12 weeks prior to planned randomization or&#xD;
             are expected to need/receive a live vaccine during the course of the study (with the&#xD;
             exception of herpes zoster vaccination)&#xD;
&#xD;
          -  Have a current or recent clinically serious viral, bacterial, fungal, or parasitic&#xD;
             infection&#xD;
&#xD;
          -  Have had symptomatic herpes zoster infection within 12 weeks prior to study entry&#xD;
&#xD;
          -  Have a history of disseminated/complicated herpes zoster (eg, multidermatomal&#xD;
             involvement, ophthalmic zoster, central nervous system involvement, or postherpetic&#xD;
             neuralgia)&#xD;
&#xD;
          -  Are immunocompromised and, in the opinion of the investigator, are at an unacceptable&#xD;
             risk for participating in the study&#xD;
&#xD;
          -  Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human&#xD;
             immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Have screening laboratory test values, including thyroid-stimulating hormone (TSH),&#xD;
             outside the reference range for the population or investigative site that, in the&#xD;
             opinion of the investigator, pose an unacceptable risk for the participant's&#xD;
             participation in the study&#xD;
&#xD;
          -  Have screening electrocardiogram (ECG) abnormalities that, in the opinion of the&#xD;
             investigator or the sponsor, are clinically significant and indicate an unacceptable&#xD;
             risk for the participant's participation in the study&#xD;
&#xD;
          -  Have symptomatic herpes simplex at the time of study enrollment&#xD;
&#xD;
          -  Have evidence of active or latent tuberculosis (TB)&#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>Arizona Arthritis &amp; Rheumatology Research</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Valley Arthritis Center, LTD</name>
      <address>
        <city>Peoria</city>
        <state>Arizona</state>
        <zip>85381</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Arthritis Care, LLC</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Boards Regent</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Endocrine, Fresno</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert Medical Advances</name>
      <address>
        <city>Palm Desert</city>
        <state>California</state>
        <zip>92260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Arthritis Center</name>
      <address>
        <city>Santa Maria</city>
        <state>California</state>
        <zip>93454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inlande Rheumatology Clinical Trials</name>
      <address>
        <city>Upland</city>
        <state>California</state>
        <zip>91786</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boulder Medical Center</name>
      <address>
        <city>Boulder</city>
        <state>Colorado</state>
        <zip>80304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center of CT/NY</name>
      <address>
        <city>Danbury</city>
        <state>Connecticut</state>
        <zip>06810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New England Research Associates</name>
      <address>
        <city>Trumbull</city>
        <state>Connecticut</state>
        <zip>06611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delaware Arthritis</name>
      <address>
        <city>Lewes</city>
        <state>Delaware</state>
        <zip>19958</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopedic Research Institute</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jeffrey Alper, M.D.</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Coast Clinical Research, Inc</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34652</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumatology Associates of Central Florida</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Integral Rheumatology &amp; Immunology Specialists</name>
      <address>
        <city>Plantation</city>
        <state>Florida</state>
        <zip>33324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McIlwain Medical Group</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University Health</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostic Rheumatology and Research</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Goldpoint Clinical Research LLC</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Michigan Rheumatology</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49546</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. George Timothy Kelly</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(AOA) Arthritis &amp; Osteoporosis Associates</name>
      <address>
        <city>Freehold</city>
        <state>New Jersey</state>
        <zip>07728</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bio Behavioral Health</name>
      <address>
        <city>Toms River</city>
        <state>New Jersey</state>
        <zip>08755</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drug Trials of America</name>
      <address>
        <city>Hartsdale</city>
        <state>New York</state>
        <zip>10530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asheville Rheumatology &amp; Osteoporosis Research Assoc, PA</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paramount Medical Research</name>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Research Institute</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Healthcare Research Consultant</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Penn Rheumatology</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center of Reading, LLP</name>
      <address>
        <city>Wyomissing</city>
        <state>Pennsylvania</state>
        <zip>19610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Rheumatology and Neurology Associates</name>
      <address>
        <city>Myrtle Beach</city>
        <state>South Carolina</state>
        <zip>29572</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metroplex Clinical Research Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pioneer Research Solutions</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accurate Clinical Research</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthritis &amp; Osteoporosis Associates LLP</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79424</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accurate Clinical Research</name>
      <address>
        <city>Nassau Bay</city>
        <state>Texas</state>
        <zip>77058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accurate Clinical Research</name>
      <address>
        <city>Webster</city>
        <state>Texas</state>
        <zip>77508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Arthritis and Rheumatic Diseases, PC</name>
      <address>
        <city>Chesapeake</city>
        <state>Virginia</state>
        <zip>23320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Seattle Arthritis Clinic</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vancouver Clinic</name>
      <address>
        <city>Vancouver</city>
        <state>Washington</state>
        <zip>98664</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumatology and Immunotherapy Center</name>
      <address>
        <city>Franklin</city>
        <state>Wisconsin</state>
        <zip>53132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Bahia Blanca</city>
        <zip>B8000HXM</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Buenos Aires</city>
        <zip>CBA 1419</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Caba</city>
        <zip>C1440AAD</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Córdoba</city>
        <zip>5000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Mar Del Plata</city>
        <zip>B7600FZN</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Quilmes</city>
        <zip>B1878DVC</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Rosario</city>
        <zip>2000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>San Fernando</city>
        <zip>1646</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>San Juan</city>
        <zip>5400</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>San Miguel De Tucuman</city>
        <zip>T4000AXL</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Brussel</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Merksem</city>
        <zip>2170</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Mons</city>
        <zip>7000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y3G8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8V 3P9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Kitchener</city>
        <state>Ontario</state>
        <zip>N2M 5N6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>St. Catherines</city>
        <state>Ontario</state>
        <zip>L2N 7E4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 3L9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Trois-Rivieres</city>
        <state>Quebec</state>
        <zip>G8Z 1Y2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Beijing</city>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Bengbu</city>
        <zip>233004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Changsha</city>
        <zip>410011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Guang Zhou</city>
        <zip>510630</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Hefei</city>
        <zip>230022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Jinan</city>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Shanghai</city>
        <zip>200052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Wu Han</city>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <country>Croatia</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>128 50</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>686 01</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>46005</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>45032</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>75679</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>86021</zip>
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        <zip>67098</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>57100</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>37044</zip>
        <country>France</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>39245</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>44649</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>50937</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>97080</zip>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>11527</zip>
        <country>Greece</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>41221</zip>
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        <zip>14561</zip>
        <country>Greece</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>1023</zip>
        <country>Hungary</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>6400</zip>
        <country>Hungary</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>4400</zip>
        <country>Hungary</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>8000</zip>
        <country>Hungary</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>8200</zip>
        <country>Hungary</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>450-0002</zip>
        <country>Japan</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>284-0003</zip>
        <country>Japan</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>814-0002</zip>
        <country>Japan</country>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>730-0017</zip>
        <country>Japan</country>
      </address>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>063-0811</zip>
        <country>Japan</country>
      </address>
    </facility>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>665-0827</zip>
        <country>Japan</country>
      </address>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>316-0015</zip>
        <country>Japan</country>
      </address>
    </facility>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>305-8576</zip>
        <country>Japan</country>
      </address>
    </facility>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>020-0034</zip>
        <country>Japan</country>
      </address>
    </facility>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>275-8580</zip>
        <country>Japan</country>
      </address>
    </facility>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>761-0793</zip>
        <country>Japan</country>
      </address>
    </facility>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>211-0063</zip>
        <country>Japan</country>
      </address>
    </facility>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>224-0041</zip>
        <country>Japan</country>
      </address>
    </facility>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>862-8655</zip>
        <country>Japan</country>
      </address>
    </facility>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>510-0016</zip>
        <country>Japan</country>
      </address>
    </facility>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>380-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>850-0832</zip>
        <country>Japan</country>
      </address>
    </facility>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>957-0054</zip>
        <country>Japan</country>
      </address>
    </facility>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>870-0823</zip>
        <country>Japan</country>
      </address>
    </facility>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>700-0013</zip>
        <country>Japan</country>
      </address>
    </facility>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <zip>901-0243</zip>
        <country>Japan</country>
      </address>
    </facility>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
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        <city>Osaka</city>
        <zip>545-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Saga</city>
        <zip>843-0393</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Saitama</city>
        <zip>333-0833</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Shizuoka</city>
        <zip>420-0821</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Tochigi</city>
        <zip>329- 0498</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Tokyo</city>
        <zip>160-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Toyama</city>
        <zip>933-0874</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Yamaguchi</city>
        <zip>745-0824</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Daegu</city>
        <zip>700-712</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Daejeon</city>
        <zip>301-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Gwangju</city>
        <zip>510-757</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Incheon</city>
        <zip>400-711</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Seoul</city>
        <zip>130-702</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Suwon-Si</city>
        <zip>443-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
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    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Liepaja</city>
        <zip>LV-3401</zip>
        <country>Latvia</country>
      </address>
    </facility>
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  <location>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
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        <zip>LV-1002</zip>
        <country>Latvia</country>
      </address>
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      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Valmiera</city>
        <zip>LV-4201</zip>
        <country>Latvia</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Kaunas</city>
        <zip>LT-50128</zip>
        <country>Lithuania</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Klaipeda</city>
        <zip>LT-92288</zip>
        <country>Lithuania</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Siauliai</city>
        <zip>76231</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Guadalajara</city>
        <zip>44690</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Merida</city>
        <zip>97070</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Mexicali</city>
        <zip>21200</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Mexico</city>
        <zip>06600</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>San Luis Potosi</city>
        <zip>78213</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Tijuana</city>
        <zip>22010</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-168</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Elblag</city>
        <zip>82-300</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Gdansk</city>
        <zip>80-546</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Katowice</city>
        <zip>40-084</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Lodz</city>
        <zip>90-242</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Nadarzyn</city>
        <zip>05-830</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Warszawa</city>
        <zip>02-653</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Lisbon</city>
        <zip>1050</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Porto</city>
        <zip>4200-319</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ramon L. Ortega Colon</name>
      <address>
        <city>Carolina</city>
        <zip>00983</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Office of Dr. Ramon Toro</name>
      <address>
        <city>San German</city>
        <zip>00683</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mindful Medical Research</name>
      <address>
        <city>San Juan</city>
        <zip>00918</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Latin Clinical Trial Center</name>
      <address>
        <city>Santurce</city>
        <zip>00909</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Bucharest</city>
        <zip>10584</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400006</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Constanta</city>
        <zip>900591</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Lasi</city>
        <zip>700661</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Oradea</city>
        <zip>410028</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Targu Mures</city>
        <zip>540136</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Korolev</city>
        <zip>141060</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Moscow</city>
        <zip>115522</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Ryazan</city>
        <zip>390026</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>194291</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Saratov</city>
        <zip>410053</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Ulyanovsk</city>
        <zip>432063</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150003</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Bratislava</city>
        <zip>84231</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Partizanske</city>
        <zip>95801</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Spisska Nova Ves</city>
        <zip>052 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Topolcany</city>
        <zip>95501</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Maribor</city>
        <zip>2000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Durban</city>
        <zip>4001</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Greenacres</city>
        <zip>6057</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Pinelands</city>
        <zip>7405</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Stellenbosch</city>
        <zip>7600</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Bilbao</city>
        <zip>48013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Hospitalet De Llobregat</city>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Sabadell</city>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Sevilla</city>
        <zip>41010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Villajoyosa</city>
        <zip>03570</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Fribourg</city>
        <zip>1708</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Kaohsiung City</city>
        <zip>83301</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Neihu Taipei</city>
        <zip>114</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Taichung City</city>
        <zip>40201</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Taichung</city>
        <zip>404</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Taipei</city>
        <zip>10630</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Yongkang City</city>
        <zip>71004</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <zip>E11 1NR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Basingstoke</city>
        <state>Hampshire</state>
        <zip>RG24 9NA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Southampton</city>
        <state>Hants</state>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Aberdeen</city>
        <state>Scotland</state>
        <zip>AB25 2ZN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>North Shields</city>
        <state>Tyneside</state>
        <zip>NE29 8NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Bradford</city>
        <state>West Yorkshire</state>
        <zip>BD5 0NA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>China</country>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Latvia</country>
    <country>Lithuania</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Puerto Rico</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>Slovenia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>Netherlands</country>
  </removed_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <results_first_submitted>March 10, 2017</results_first_submitted>
  <results_first_submitted_qc>July 14, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 15, 2017</results_first_posted>
  <disposition_first_submitted>May 8, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>May 8, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">May 25, 2015</disposition_first_posted>
  <last_update_submitted>September 9, 2019</last_update_submitted>
  <last_update_submitted_qc>September 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adalimumab</mesh_term>
    <mesh_term>Methotrexate</mesh_term>
  </intervention_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>https://vivli.org/</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Participants who did not respond (nonresponders) to study drug were eligible for rescue treatment beginning at Week16. Participants not rescued at Week 16 may be rescued at the discretion of the investigator anytime thereafter.&#xD;
Nonresponders were defined as lack of improvement of at least 20% in both tender joint count and swollen joint count.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo administered orally (PO) once daily (QD) through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.&#xD;
Participants continued to take background methotrexate (MTX) therapy throughout study.</description>
        </group>
        <group group_id="P2">
          <title>Baricitinib</title>
          <description>Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
        </group>
        <group group_id="P3">
          <title>Adalimumab</title>
          <description>Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period Part A (Weeks 0 to 24)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="489"/>
                <participants group_id="P2" count="488"/>
                <participants group_id="P3" count="330"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="488"/>
                <participants group_id="P2" count="487"/>
                <participants group_id="P3" count="330"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Rescued</title>
              <participants_list>
                <participants group_id="P1" count="128"/>
                <participants group_id="P2" count="35"/>
                <participants group_id="P3" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="438">Includes all participants rescued during Part A.</participants>
                <participants group_id="P2" count="459">Includes all participants rescued during Part A.</participants>
                <participants group_id="P3" count="307">Includes all participants rescued during Part A.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="23"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Entry Criteria Not Met</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
              </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="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized But Not Treated</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Period Part B (Weeks 24 to 52)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="310">Excludes participants rescued during Part A.</participants>
                <participants group_id="P2" count="424">Excludes participants rescued during Part A.</participants>
                <participants group_id="P3" count="267">Excludes participants rescued during Part A.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="306">Participants originally randomized to placebo received baricitinib during Part B.</participants>
                <participants group_id="P2" count="424"/>
                <participants group_id="P3" count="267"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Rescued</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="294">Includes all participants rescued during Part B.</participants>
                <participants group_id="P2" count="402">Includes all participants rescued during Part B.</participants>
                <participants group_id="P3" count="252">Includes all participants rescued during Part B.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Rescue Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0">Participants who were nonresponders based on tender/swollen joint count entered into rescue group.</participants>
                <participants group_id="P2" count="227">Baricitinib 4 mg administered PO QD through Week 52. Participants continued background MTX therapy.</participants>
                <participants group_id="P3" count="0">Participants who were nonresponders based on tender/swollen joint count entered into rescue group.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="196"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="31"/>
                <participants group_id="P3" 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="0"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="0"/>
              </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="8"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Follow-up Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33">Participants from treatment who entered the post-treatment follow-up period.</participants>
                <participants group_id="P2" count="76">Rescued participants who entered post-treatment follow-up are included in Baricitinib 4mg follow up.</participants>
                <participants group_id="P3" count="20">Participants from treatment who entered the post-treatment follow-up period.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="76"/>
                <participants group_id="P3" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo administered orally once daily through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.&#xD;
Participants continued to take background methotrexate (MTX) therapy throughout study.</description>
        </group>
        <group group_id="B2">
          <title>Baricitinib</title>
          <description>Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
        </group>
        <group group_id="B3">
          <title>Adalimumab</title>
          <description>Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.&#xD;
Participants continued to take background MTX) therapy throughout study.</description>
        </group>
        <group group_id="B4">
          <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="488"/>
            <count group_id="B2" value="487"/>
            <count group_id="B3" value="330"/>
            <count group_id="B4" value="1305"/>
          </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="53.4" spread="11.8"/>
                    <measurement group_id="B2" value="53.5" spread="12.2"/>
                    <measurement group_id="B3" value="52.9" spread="12.3"/>
                    <measurement group_id="B4" value="53.3" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="382"/>
                    <measurement group_id="B2" value="375"/>
                    <measurement group_id="B3" value="251"/>
                    <measurement group_id="B4" value="1008"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="106"/>
                    <measurement group_id="B2" value="112"/>
                    <measurement group_id="B3" value="79"/>
                    <measurement group_id="B4" value="297"/>
                  </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="26"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="148"/>
                    <measurement group_id="B2" value="143"/>
                    <measurement group_id="B3" value="101"/>
                    <measurement group_id="B4" value="392"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="302"/>
                    <measurement group_id="B2" value="312"/>
                    <measurement group_id="B3" value="204"/>
                    <measurement group_id="B4" value="818"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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="1"/>
                  </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="91"/>
                    <measurement group_id="B2" value="107"/>
                    <measurement group_id="B3" value="57"/>
                    <measurement group_id="B4" value="255"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Croatia</title>
              <category_list>
                <category>
                  <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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czechia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Greece</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="63"/>
                    <measurement group_id="B4" value="249"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Korea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Latvia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lithuania</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mexico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Portugal</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Romania</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slovakia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slovenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Africa</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taiwan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Rheumatoid Arthritis</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.4" spread="8.7"/>
                    <measurement group_id="B2" value="10.3" spread="8.8"/>
                    <measurement group_id="B3" value="9.6" spread="8.5"/>
                    <measurement group_id="B4" value="10.1" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tender Joint Count of 68 Evaluable Joints</title>
          <units>Number of Joints</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.3" spread="13.5"/>
                    <measurement group_id="B2" value="23.4" spread="13.0"/>
                    <measurement group_id="B3" value="23.4" spread="13.7"/>
                    <measurement group_id="B4" value="23.4" spread="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Swollen Joint Count of 66 Evaluable Joints</title>
          <units>Number of Joints</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.5" spread="9.4"/>
                    <measurement group_id="B2" value="15.0" spread="8.2"/>
                    <measurement group_id="B3" value="15.4" spread="9.1"/>
                    <measurement group_id="B4" value="15.3" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>High Sensitivity C-Reactive Protein (hsCRP)</title>
          <units>milligrams per liter (mg/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19.66" spread="20.97"/>
                    <measurement group_id="B2" value="22.20" spread="22.85"/>
                    <measurement group_id="B3" value="21.78" spread="20.83"/>
                    <measurement group_id="B4" value="21.14" spread="21.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)</title>
        <description>ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). &quot;ACR20 Responder&quot; is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis timepoint were deemed non-responders.</description>
        <time_frame>Week 12</time_frame>
        <population>Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using nonresponder imputation (NRI).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab</title>
            <description>Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)</title>
          <description>ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). &quot;ACR20 Responder&quot; is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis timepoint were deemed non-responders.</description>
          <population>Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using nonresponder imputation (NRI).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="488"/>
                <count group_id="O2" value="487"/>
                <count group_id="O3" value="330"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.2"/>
                    <measurement group_id="O2" value="69.6"/>
                    <measurement group_id="O3" value="61.2"/>
                  </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 or Other (legacy)</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Regression, Logistic</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Modified Total Sharp Score (mTSS)</title>
        <description>X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing for 44 and 42 joints, with higher scores representing greater damage.&#xD;
The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessments. Missing values due to discontinuation of study, rescue, or missing data were imputed using linear extrapolation (LE).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab</title>
            <description>Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who are were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.&#xD;
Participants will continued to take background MTX therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Modified Total Sharp Score (mTSS)</title>
          <description>X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing for 44 and 42 joints, with higher scores representing greater damage.&#xD;
The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessments. Missing values due to discontinuation of study, rescue, or missing data were imputed using linear extrapolation (LE).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="452"/>
                <count group_id="O2" value="470"/>
                <count group_id="O3" value="312"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.84" spread="2.32"/>
                    <measurement group_id="O2" value="0.35" spread="1.59"/>
                    <measurement group_id="O3" value="0.29" spread="1.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score</title>
        <description>The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty (0 [without any difficulty], 1 [with some difficulty], 2 [with much difficulty], and 3 [unable to do]) when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified baseline observation carried forward (mBOCF).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib will continue to receive baricitinib 4 mg administered orally once daily through Week 52.&#xD;
Participants will continue to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab</title>
            <description>Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 52.&#xD;
Participants will continue to take background MTX therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score</title>
          <description>The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty (0 [without any difficulty], 1 [with some difficulty], 2 [with much difficulty], and 3 [unable to do]) when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.</description>
          <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified baseline observation carried forward (mBOCF).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="488"/>
                <count group_id="O2" value="487"/>
                <count group_id="O3" value="330"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.33" spread="0.51"/>
                    <measurement group_id="O2" value="-0.65" spread="0.59"/>
                    <measurement group_id="O3" value="-0.56" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)</title>
        <description>Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.&#xD;
.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab</title>
            <description>Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)</title>
          <description>Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.</description>
          <population>mITT population includes all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="488"/>
                <count group_id="O2" value="487"/>
                <count group_id="O3" value="330"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.01" spread="1.12"/>
                    <measurement group_id="O2" value="-2.27" spread="1.22"/>
                    <measurement group_id="O3" value="-1.98" spread="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response</title>
        <description>ACR50 and ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR50 and ACR70 Responder is a participant who has at least 50% or 70% improvement, respectively, in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP.&#xD;
Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders.</description>
        <time_frame>Week 12, Week 24, Week 52</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab</title>
            <description>Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response</title>
          <description>ACR50 and ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR50 and ACR70 Responder is a participant who has at least 50% or 70% improvement, respectively, in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP.&#xD;
Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="488"/>
                <count group_id="O2" value="487"/>
                <count group_id="O3" value="330"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ACR50 Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.8"/>
                    <measurement group_id="O2" value="45.0"/>
                    <measurement group_id="O3" value="34.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR50 Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.3"/>
                    <measurement group_id="O2" value="50.5"/>
                    <measurement group_id="O3" value="45.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR50 Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">No data available. There is no Placebo Arm at week 52.</measurement>
                    <measurement group_id="O2" value="55.9"/>
                    <measurement group_id="O3" value="47.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR70 Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7"/>
                    <measurement group_id="O2" value="18.9"/>
                    <measurement group_id="O3" value="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR70 Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0"/>
                    <measurement group_id="O2" value="29.8"/>
                    <measurement group_id="O3" value="21.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR70 Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">No data available. There is no Placebo Arm at week 52.</measurement>
                    <measurement group_id="O2" value="37.2"/>
                    <measurement group_id="O3" value="30.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Disease Activity Index (CDAI) Score</title>
        <description>The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.</description>
        <time_frame>Baseline, Week 12, Week 24, Week 52</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of the study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified last observation carried forward (mLOCF).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab</title>
            <description>Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Disease Activity Index (CDAI) Score</title>
          <description>The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of the study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified last observation carried forward (mLOCF).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="481"/>
                <count group_id="O2" value="478"/>
                <count group_id="O3" value="324"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.53" spread="13.88"/>
                    <measurement group_id="O2" value="-23.00" spread="12.66"/>
                    <measurement group_id="O3" value="-20.42" spread="13.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.21" spread="15.13"/>
                    <measurement group_id="O2" value="-25.04" spread="13.61"/>
                    <measurement group_id="O3" value="-22.92" spread="14.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">NA= No data available. There is no Placebo Arm at week 52.</measurement>
                    <measurement group_id="O2" value="-26.44" spread="14.42"/>
                    <measurement group_id="O3" value="-23.48" spread="15.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Score ≤3.3</title>
        <description>SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.</description>
        <time_frame>Week 12, Week 24, Week 52</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab</title>
            <description>Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Score ≤3.3</title>
          <description>SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="488"/>
                <count group_id="O2" value="487"/>
                <count group_id="O3" value="330"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8"/>
                    <measurement group_id="O2" value="8.4"/>
                    <measurement group_id="O3" value="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1"/>
                    <measurement group_id="O2" value="16.0"/>
                    <measurement group_id="O3" value="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">NA= No data available. There is no Placebo Arm at week 52.</measurement>
                    <measurement group_id="O2" value="22.6"/>
                    <measurement group_id="O3" value="17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission - Boolean Remission</title>
        <description>The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.</description>
        <time_frame>Week 12, Week 24, Week 52</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.&#xD;
Baricitinib: Administered orally</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab</title>
            <description>Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission - Boolean Remission</title>
          <description>The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="488"/>
                <count group_id="O2" value="487"/>
                <count group_id="O3" value="330"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0"/>
                    <measurement group_id="O2" value="7.2"/>
                    <measurement group_id="O3" value="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7"/>
                    <measurement group_id="O2" value="12.1"/>
                    <measurement group_id="O3" value="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">NA= No data available. There is no Placebo Arm at week 52.</measurement>
                    <measurement group_id="O2" value="15.6"/>
                    <measurement group_id="O3" value="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median of Individual Participant Mean Duration of Morning Joint Stiffness in the Prior 7 Days as Collected in Electronic Diaries</title>
        <description>Participants recorded the duration of their morning joint stiffness (MJS) in hours and minutes into electronic diaries daily. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit was calculated. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.</description>
        <time_frame>Week 12</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab</title>
            <description>Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Median of Individual Participant Mean Duration of Morning Joint Stiffness in the Prior 7 Days as Collected in Electronic Diaries</title>
          <description>Participants recorded the duration of their morning joint stiffness (MJS) in hours and minutes into electronic diaries daily. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit was calculated. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.</population>
          <units>Minutes</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="479"/>
                <count group_id="O2" value="479"/>
                <count group_id="O3" value="323"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.0" lower_limit="60.0" upper_limit="75.0"/>
                    <measurement group_id="O2" value="27.1" lower_limit="20.0" upper_limit="30.0"/>
                    <measurement group_id="O3" value="36.6" lower_limit="30.0" upper_limit="45.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries</title>
        <description>Participants rated the severity of their morning joint stiffness by selecting a number from 0 to 10 that best described their overall level of morning joint stiffness from the time they woke up, where 0 represents &quot;no joint stiffness&quot; and 10 represents &quot;joint stiffness as bad as you can imagine&quot;. Participants reported their severity daily in electronic diaries. The average value across the 7 days preceding each visit was calculated.</description>
        <time_frame>Week 12</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab</title>
            <description>Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries</title>
          <description>Participants rated the severity of their morning joint stiffness by selecting a number from 0 to 10 that best described their overall level of morning joint stiffness from the time they woke up, where 0 represents &quot;no joint stiffness&quot; and 10 represents &quot;joint stiffness as bad as you can imagine&quot;. Participants reported their severity daily in electronic diaries. The average value across the 7 days preceding each visit was calculated.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="479"/>
                <count group_id="O2" value="479"/>
                <count group_id="O3" value="323"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="2.3"/>
                    <measurement group_id="O2" value="3.0" spread="2.2"/>
                    <measurement group_id="O3" value="3.4" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries</title>
        <description>Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents &quot;no tiredness&quot; and 10 represents &quot;as bad as you can imagine&quot;. Participants reported their worst tiredness in electronic diaries. The average value across the 7 days preceding each visit is calculated.</description>
        <time_frame>Week 12</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab</title>
            <description>Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries</title>
          <description>Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents &quot;no tiredness&quot; and 10 represents &quot;as bad as you can imagine&quot;. Participants reported their worst tiredness in electronic diaries. The average value across the 7 days preceding each visit is calculated.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="479"/>
                <count group_id="O2" value="479"/>
                <count group_id="O3" value="323"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" spread="2.3"/>
                    <measurement group_id="O2" value="3.6" spread="2.2"/>
                    <measurement group_id="O3" value="3.9" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Worst Joint Pain NRS in the Prior 7 Days as Collected in Electronic Diaries</title>
        <description>Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents &quot;no pain&quot; and 10 represents &quot;pain as bad as you can imagine&quot;. Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit was calculated.</description>
        <time_frame>Week 12</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab</title>
            <description>Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Worst Joint Pain NRS in the Prior 7 Days as Collected in Electronic Diaries</title>
          <description>Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents &quot;no pain&quot; and 10 represents &quot;pain as bad as you can imagine&quot;. Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit was calculated.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="479"/>
                <count group_id="O2" value="479"/>
                <count group_id="O3" value="323"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" spread="2.2"/>
                    <measurement group_id="O2" value="3.4" spread="2.2"/>
                    <measurement group_id="O3" value="4.0" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores</title>
        <description>The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (&quot;Not at all&quot;) to 4 (&quot;Very much&quot;) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.</description>
        <time_frame>Baseline, Week 12, Week 24, Week 52</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab</title>
            <description>Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores</title>
          <description>The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (&quot;Not at all&quot;) to 4 (&quot;Very much&quot;) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="475"/>
                <count group_id="O2" value="479"/>
                <count group_id="O3" value="320"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8" spread="9.9"/>
                    <measurement group_id="O2" value="9.6" spread="10.4"/>
                    <measurement group_id="O3" value="9.5" spread="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" spread="10.4"/>
                    <measurement group_id="O2" value="10.4" spread="10.8"/>
                    <measurement group_id="O3" value="9.9" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">NA= No data available. There is no Placebo Arm at week 52.</measurement>
                    <measurement group_id="O2" value="10.8" spread="10.9"/>
                    <measurement group_id="O3" value="9.8" spread="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)</title>
        <description>The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.</description>
        <time_frame>Baseline, Week 12, Week 24, Week 52</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab</title>
            <description>Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)</title>
          <description>The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="475"/>
                <count group_id="O2" value="479"/>
                <count group_id="O3" value="320"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MCS Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="10.3"/>
                    <measurement group_id="O2" value="3.3" spread="10.5"/>
                    <measurement group_id="O3" value="3.8" spread="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCS Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="11.4"/>
                    <measurement group_id="O2" value="3.8" spread="10.9"/>
                    <measurement group_id="O3" value="3.9" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCS Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No data available. There is no Placebo Arm at week 52.</measurement>
                    <measurement group_id="O2" value="4.0" spread="10.8"/>
                    <measurement group_id="O3" value="3.7" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PCS Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="7.1"/>
                    <measurement group_id="O2" value="8.9" spread="8.1"/>
                    <measurement group_id="O3" value="7.6" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PCS Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" spread="7.8"/>
                    <measurement group_id="O2" value="9.9" spread="8.2"/>
                    <measurement group_id="O3" value="8.3" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PCS Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No data available. There is no Placebo Arm at week 52.</measurement>
                    <measurement group_id="O2" value="10.4" spread="9.0"/>
                    <measurement group_id="O3" value="9.0" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores</title>
        <description>European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.</description>
        <time_frame>Baseline, Week 12, Week 24, Week 52</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab</title>
            <description>Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores</title>
          <description>European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="475"/>
                <count group_id="O2" value="479"/>
                <count group_id="O3" value="320"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Index Score (US Algorithm) Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.073" spread="0.151"/>
                    <measurement group_id="O2" value="0.132" spread="0.156"/>
                    <measurement group_id="O3" value="0.130" spread="0.159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Index Score (US Algorithm) Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.065" spread="0.168"/>
                    <measurement group_id="O2" value="0.143" spread="0.168"/>
                    <measurement group_id="O3" value="0.137" spread="0.167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Index Score (US Algorithm) Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">NA= No data available. There is no Placebo Arm at week 52.</measurement>
                    <measurement group_id="O2" value="0.152" spread="0.163"/>
                    <measurement group_id="O3" value="0.141" spread="0.189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Index Score (UK Algorithm) Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.107" spread="0.221"/>
                    <measurement group_id="O2" value="0.188" spread="0.228"/>
                    <measurement group_id="O3" value="0.186" spread="0.232"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Index Score (UK Algorithm) Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.094" spread="0.247"/>
                    <measurement group_id="O2" value="0.203" spread="0.244"/>
                    <measurement group_id="O3" value="0.195" spread="0.245"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Index Score (UK Algorithm) Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">NA= No data available. There is no Placebo Arm at week 52.</measurement>
                    <measurement group_id="O2" value="0.215" spread="0.235"/>
                    <measurement group_id="O3" value="0.198" spread="0.273"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)</title>
        <description>A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.</description>
        <time_frame>Baseline, Week 12, Week 24, Week 52</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab</title>
            <description>Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)</title>
          <description>A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.</description>
          <population>mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.</population>
          <units>millimeter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="475"/>
                <count group_id="O2" value="479"/>
                <count group_id="O3" value="320"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Self-Perceived Health Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9" spread="26.2"/>
                    <measurement group_id="O2" value="14.9" spread="25.8"/>
                    <measurement group_id="O3" value="10.7" spread="26.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-Perceived Health Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" spread="27.1"/>
                    <measurement group_id="O2" value="17.5" spread="28.3"/>
                    <measurement group_id="O3" value="12.6" spread="28.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-Perceived Health Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">NA= No data available. There is no Placebo Arm at week 52.</measurement>
                    <measurement group_id="O2" value="19.9" spread="28.0"/>
                    <measurement group_id="O3" value="13.3" spread="29.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores</title>
        <description>The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.</description>
        <time_frame>Baseline, Week 12, Week 24, Week 52</time_frame>
        <population>mITT population includes all randomized participants who received at least 1 dose of the study drug, with a baseline value and an observed value at the time point being summarized.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.&#xD;
Baricitinib: Administered orally</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab</title>
            <description>Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores</title>
          <description>The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.</description>
          <population>mITT population includes all randomized participants who received at least 1 dose of the study drug, with a baseline value and an observed value at the time point being summarized.</population>
          <units>percentage of impairment</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="458"/>
                <count group_id="O2" value="474"/>
                <count group_id="O3" value="315"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Absenteeism Week 12 (n=160,168,118)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="27.7"/>
                    <measurement group_id="O2" value="-4.9" spread="20.6"/>
                    <measurement group_id="O3" value="-0.5" spread="25.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absenteeism Week 24 (n=118,139,102)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="24.5"/>
                    <measurement group_id="O2" value="-1.8" spread="25.2"/>
                    <measurement group_id="O3" value="-3.2" spread="23.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absenteeism Week 52 (n=0,124,92)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">NA= No data available. There is no Placebo Arm at week 52.</measurement>
                    <measurement group_id="O2" value="-3.8" spread="25.1"/>
                    <measurement group_id="O3" value="-3.7" spread="24.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Presenteeism Week 12 (n=147,160,113)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11" spread="23"/>
                    <measurement group_id="O2" value="-21" spread="26"/>
                    <measurement group_id="O3" value="-16" spread="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Presenteeism Week 24 (n=110,134,99)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11" spread="22"/>
                    <measurement group_id="O2" value="-23" spread="27"/>
                    <measurement group_id="O3" value="-22" spread="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Presenteeism Week 52 (n=0,119,88)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">NA= No data available. There is no Placebo Arm at week 52.</measurement>
                    <measurement group_id="O2" value="-25" spread="27"/>
                    <measurement group_id="O3" value="-25" spread="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work Productivity Loss Week 12 (n=147,160,113)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.4" spread="24.3"/>
                    <measurement group_id="O2" value="-21.6" spread="28.0"/>
                    <measurement group_id="O3" value="-14.0" spread="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work Productivity Loss Week 24 (n=110,134,99)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.0" spread="24.9"/>
                    <measurement group_id="O2" value="-22.1" spread="30.2"/>
                    <measurement group_id="O3" value="-21.4" spread="27.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work Productivity Loss Week 52 (n=0,119,88)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">NA= No data available. There is no Placebo Arm at week 52.</measurement>
                    <measurement group_id="O2" value="-24.4" spread="30.1"/>
                    <measurement group_id="O3" value="-24.6" spread="29.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity Impairment Week 12 (n=458,474,315)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11" spread="25"/>
                    <measurement group_id="O2" value="-25" spread="26"/>
                    <measurement group_id="O3" value="-20" spread="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity Impairment Week 24 (n=333,430,272)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16" spread="26"/>
                    <measurement group_id="O2" value="-28" spread="27"/>
                    <measurement group_id="O3" value="-26" spread="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity Impairment Week 52 (n=0,396,240)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">NA= No data available. There is no Placebo Arm at week 52.</measurement>
                    <measurement group_id="O2" value="-30" spread="27"/>
                    <measurement group_id="O3" value="-28" spread="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Joint Space Narrowing (JSN) and Bone Erosion Scores</title>
        <description>X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.&#xD;
The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints, with 0 indicating no erosion and the highest score (5 for the hand and 10 for the foot) indicating extensive loss of bone from more than one half of the articulating bone. Erosion scores ranged from 0 (no erosion) to 280 (high erosion).</description>
        <time_frame>Baseline, Week 24, Week 52</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment. Missing values due to discontinuation of study, rescue, or missing data were imputed using LE.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.&#xD;
Baricitinib: Administered orally</description>
          </group>
          <group group_id="O3">
            <title>Adalimumab</title>
            <description>Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.&#xD;
Participants continued to take background MTX therapy throughout study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Joint Space Narrowing (JSN) and Bone Erosion Scores</title>
          <description>X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.&#xD;
The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints, with 0 indicating no erosion and the highest score (5 for the hand and 10 for the foot) indicating extensive loss of bone from more than one half of the articulating bone. Erosion scores ranged from 0 (no erosion) to 280 (high erosion).</description>
          <population>mITT population: all randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment. Missing values due to discontinuation of study, rescue, or missing data were imputed using LE.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="452"/>
                <count group_id="O2" value="473"/>
                <count group_id="O3" value="312"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Joint Space Narrowing Week 24 (n= 452, 470, 312)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.27" spread="1.15"/>
                    <measurement group_id="O2" value="0.10" spread="0.74"/>
                    <measurement group_id="O3" value="0.09" spread="0.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Joint Space Narrowing Week 52 (n= 452, 473, 312)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.56" spread="2.33"/>
                    <measurement group_id="O2" value="0.18" spread="1.02"/>
                    <measurement group_id="O3" value="0.17" spread="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bone Erosion Score Week 24 (n=452, 470, 312)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.57" spread="1.58"/>
                    <measurement group_id="O2" value="0.25" spread="1.12"/>
                    <measurement group_id="O3" value="0.20" spread="1.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bone Erosion Score Week 52 (n= 452, 473, 312)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.15" spread="3.21"/>
                    <measurement group_id="O2" value="0.42" spread="1.91"/>
                    <measurement group_id="O3" value="0.34" spread="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Population Pharmacokinetics (PK): Peak Concentration at Steady State (Cmax,ss) of Baricitinib</title>
        <time_frame>Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 12; Week 24; Week 32: Pre-dose</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52</description>
          </group>
        </group_list>
        <measure>
          <title>Population Pharmacokinetics (PK): Peak Concentration at Steady State (Cmax,ss) of Baricitinib</title>
          <population>All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.</population>
          <units>nanomole/Liter (nmol/L)</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="635"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143" spread="19.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Population PK: Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib</title>
        <time_frame>Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 12; Week 24; Week 32: Pre-dose</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52</description>
          </group>
        </group_list>
        <measure>
          <title>Population PK: Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib</title>
          <population>All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.</population>
          <units>nanomole*hr/Liter (nmol*hr/L)</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="635"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1220" spread="45.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo Treatment A</title>
          <description>Placebo Treatment A (week 0-24).&#xD;
Placebo administered orally (PO) once daily (QD) through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.</description>
        </group>
        <group group_id="E2">
          <title>Baricitinib Treatment A</title>
          <description>Baricitinib Treatment A (week 0-24).&#xD;
Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.</description>
        </group>
        <group group_id="E3">
          <title>Adalimumab Treatment A</title>
          <description>Adalimumab Treatment A (week 0-24).&#xD;
Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.</description>
        </group>
        <group group_id="E4">
          <title>Placebo Treatment B</title>
          <description>Placebo Treatment B (week 24-52).&#xD;
Placebo administered orally (PO) once daily (QD) through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.&#xD;
At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.</description>
        </group>
        <group group_id="E5">
          <title>BaricitinibTreatment B</title>
          <description>Baricitinib Treatment B (week 24-52).&#xD;
Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.&#xD;
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.</description>
        </group>
        <group group_id="E6">
          <title>Adalimumab Treatment B</title>
          <description>Adalimumab Treatment B (week 24-52).&#xD;
Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.&#xD;
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.</description>
        </group>
        <group group_id="E7">
          <title>Rescue</title>
          <description>Baricitinib 4 mg administered PO QD through Week 52 (Week 16-52).</description>
        </group>
        <group group_id="E8">
          <title>Placebo Follow-up</title>
          <description>No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.</description>
        </group>
        <group group_id="E9">
          <title>Baricitinib Follow-up</title>
          <description>No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug. Participants who were rescued or switched to Baricitinib 4 mg.</description>
        </group>
        <group group_id="E10">
          <title>Adalimumab Follow-up</title>
          <description>No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (18.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="488"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="487"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="330"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="306"/>
                <counts group_id="E5" subjects_affected="16" subjects_at_risk="424"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_affected="17" subjects_at_risk="227"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Lymphocytosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="424"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </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="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Macular fibrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Duodenal ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Jejunal ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Cholangitis sclerosing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Arthritis infective</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Disseminated tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Epiglottitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Muscle abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Cholecystitis infective</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Escherichia sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Necrotising fasciitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pneumonia pseudomonal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Arthritis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Ulna fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Post concussion syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </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="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypoproteinaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Chondrocalcinosis pyrophosphate</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Lung squamous cell carcinoma stage III</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Ovarian cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Clear cell renal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Lymphoproliferative disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of lung</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Generalised anxiety disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Calculus urinary</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nephrosclerosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Metrorrhagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nasal septum perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Hysterectomy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Bladder repair</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Fracture treatment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Knee arthroplasty</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA (18.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="177" subjects_at_risk="488"/>
                <counts group_id="E2" subjects_affected="196" subjects_at_risk="487"/>
                <counts group_id="E3" subjects_affected="132" subjects_at_risk="330"/>
                <counts group_id="E4" subjects_affected="58" subjects_at_risk="306"/>
                <counts group_id="E5" subjects_affected="70" subjects_at_risk="424"/>
                <counts group_id="E6" subjects_affected="38" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_affected="46" subjects_at_risk="227"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="16" subjects_affected="15" subjects_at_risk="488"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="487"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="9" subjects_affected="8" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blepharitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="16" subjects_affected="14" subjects_at_risk="488"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="487"/>
                <counts group_id="E3" events="10" subjects_affected="8" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="488"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="487"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="488"/>
                <counts group_id="E2" events="15" subjects_affected="14" subjects_at_risk="487"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="6" subjects_affected="5" subjects_at_risk="227"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="488"/>
                <counts group_id="E2" events="22" subjects_affected="19" subjects_at_risk="487"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="330"/>
                <counts group_id="E4" events="12" subjects_affected="11" subjects_at_risk="306"/>
                <counts group_id="E5" events="12" subjects_affected="12" subjects_at_risk="424"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="267"/>
                <counts group_id="E7" events="7" subjects_affected="6" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="488"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="487"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="330"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="306"/>
                <counts group_id="E5" events="10" subjects_affected="10" subjects_at_risk="424"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" events="5" subjects_affected="5" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="39" subjects_affected="35" subjects_at_risk="488"/>
                <counts group_id="E2" events="41" subjects_affected="37" subjects_at_risk="487"/>
                <counts group_id="E3" events="40" subjects_affected="34" subjects_at_risk="330"/>
                <counts group_id="E4" events="19" subjects_affected="15" subjects_at_risk="306"/>
                <counts group_id="E5" events="26" subjects_affected="24" subjects_at_risk="424"/>
                <counts group_id="E6" events="15" subjects_affected="14" subjects_at_risk="267"/>
                <counts group_id="E7" events="11" subjects_affected="9" subjects_at_risk="227"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="488"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="487"/>
                <counts group_id="E3" events="12" subjects_affected="12" subjects_at_risk="330"/>
                <counts group_id="E4" events="12" subjects_affected="10" subjects_at_risk="306"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="424"/>
                <counts group_id="E6" events="7" subjects_affected="7" subjects_at_risk="267"/>
                <counts group_id="E7" events="10" subjects_affected="5" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="15" subjects_affected="14" subjects_at_risk="488"/>
                <counts group_id="E2" events="17" subjects_affected="15" subjects_at_risk="487"/>
                <counts group_id="E3" events="16" subjects_affected="13" subjects_at_risk="330"/>
                <counts group_id="E4" events="10" subjects_affected="10" subjects_at_risk="306"/>
                <counts group_id="E5" events="13" subjects_affected="13" subjects_at_risk="424"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="267"/>
                <counts group_id="E7" events="7" subjects_affected="6" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="488"/>
                <counts group_id="E2" events="25" subjects_affected="21" subjects_at_risk="487"/>
                <counts group_id="E3" events="14" subjects_affected="13" subjects_at_risk="330"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="306"/>
                <counts group_id="E5" events="10" subjects_affected="10" subjects_at_risk="424"/>
                <counts group_id="E6" events="6" subjects_affected="5" subjects_at_risk="267"/>
                <counts group_id="E7" events="6" subjects_affected="5" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="488"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="487"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="488"/>
                <counts group_id="E2" events="15" subjects_affected="13" subjects_at_risk="487"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="5" subjects_affected="5" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="488"/>
                <counts group_id="E2" events="15" subjects_affected="15" subjects_at_risk="487"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="488"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="487"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="488"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="487"/>
                <counts group_id="E3" events="13" subjects_affected="10" subjects_at_risk="330"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="306"/>
                <counts group_id="E5" events="9" subjects_affected="9" subjects_at_risk="424"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" events="15" subjects_affected="14" subjects_at_risk="488"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="487"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="488"/>
                <counts group_id="E2" events="17" subjects_affected="14" subjects_at_risk="487"/>
                <counts group_id="E3" events="16" subjects_affected="13" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Calculus prostatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="488"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="487"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </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="9" subjects_affected="8" subjects_at_risk="488"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="487"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="488"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="487"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="488"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="487"/>
                <counts group_id="E3" events="11" subjects_affected="11" subjects_at_risk="330"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="306"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="424"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="227"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </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>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
    </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/NCT01710358
org study id: 13978
secondary id: I4V-MC-JADV
nct id: NCT01710358
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether baricitinib is superior to placebo in the
      treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who
      have had an inadequate response to methotrexate (MTX) treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)
time frame: Week 12
description: ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "ACR20 Responder" is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis timepoint were deemed non-responders.
measure: Change From Baseline in the Modified Total Sharp Score (mTSS)
time frame: Baseline, Week 24
description: X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing for 44 and 42 joints, with higher scores representing greater damage.
The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448.
measure: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
time frame: Baseline, Week 12
description: The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty (0 [without any difficulty], 1 [with some difficulty], 2 [with much difficulty], and 3 [unable to do]) when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
measure: Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)
time frame: Baseline, Week 12
description: Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response
time frame: Week 12, Week 24, Week 52
description: ACR50 and ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR50 and ACR70 Responder is a participant who has at least 50% or 70% improvement, respectively, in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP.
Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders.
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) Score
time frame: Baseline, Week 12, Week 24, Week 52
description: The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
measure: Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Score ≤3.3
time frame: Week 12, Week 24, Week 52
description: SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.
measure: Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission - Boolean Remission
time frame: Week 12, Week 24, Week 52
description: The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.
measure: Median of Individual Participant Mean Duration of Morning Joint Stiffness in the Prior 7 Days as Collected in Electronic Diaries
time frame: Week 12
description: Participants recorded the duration of their morning joint stiffness (MJS) in hours and minutes into electronic diaries daily. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit was calculated. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
measure: Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries
time frame: Week 12
description: Participants rated the severity of their morning joint stiffness by selecting a number from 0 to 10 that best described their overall level of morning joint stiffness from the time they woke up, where 0 represents "no joint stiffness" and 10 represents "joint stiffness as bad as you can imagine". Participants reported their severity daily in electronic diaries. The average value across the 7 days preceding each visit was calculated.
measure: Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries
time frame: Week 12
description: Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents "no tiredness" and 10 represents "as bad as you can imagine". Participants reported their worst tiredness in electronic diaries. The average value across the 7 days preceding each visit is calculated.
measure: Mean Worst Joint Pain NRS in the Prior 7 Days as Collected in Electronic Diaries
time frame: Week 12
description: Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine". Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit was calculated.
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores
time frame: Baseline, Week 12, Week 24, Week 52
description: The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 ("Not at all") to 4 ("Very much") for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.
measure: Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)
time frame: Baseline, Week 12, Week 24, Week 52
description: The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.
measure: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores
time frame: Baseline, Week 12, Week 24, Week 52
description: European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
measure: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
time frame: Baseline, Week 12, Week 24, Week 52
description: A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.
measure: Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
time frame: Baseline, Week 12, Week 24, Week 52
description: The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.
measure: Change From Baseline in Joint Space Narrowing (JSN) and Bone Erosion Scores
time frame: Baseline, Week 24, Week 52
description: X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.
The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints, with 0 indicating no erosion and the highest score (5 for the hand and 10 for the foot) indicating extensive loss of bone from more than one half of the articulating bone. Erosion scores ranged from 0 (no erosion) to 280 (high erosion).
measure: Population Pharmacokinetics (PK): Peak Concentration at Steady State (Cmax,ss) of Baricitinib
time frame: Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 12; Week 24; Week 32: Pre-dose
measure: Population PK: Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib
time frame: Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 12; Week 24; Week 32: Pre-dose
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo administered orally once daily through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.
At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.
Participants continued to take background methotrexate (MTX) therapy throughout study.
arm group label: Baricitinib
arm group type: Experimental
description: Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.
Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.
Participants continued to take background methotrexate (MTX) therapy throughout study.
arm group label: Adalimumab
arm group type: Active Comparator
description: Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.
Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.
Participants continued to take background methotrexate (MTX) therapy throughout study.
intervention type: Drug
intervention name: Adalimumab
description: Administered SC
arm group label: Adalimumab
intervention type: Drug
intervention name: Baricitinib
description: Administered orally
arm group label: Baricitinib
other name: LY 3009104
intervention type: Drug
intervention name: Methotrexate
description: Administered orally
arm group label: Adalimumab
arm group label: Baricitinib
arm group label: Placebo
intervention type: Drug
intervention name: Adalimumab Placebo
description: Adalimumab placebo administered SC.
arm group label: Baricitinib
arm group label: Placebo
intervention type: Drug
intervention name: Baricitinib Placebo
description: Baricitinib placebo administered orally.
arm group label: Adalimumab
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: Belgium
country: Canada
country: China
country: Croatia
country: Czechia
country: France
country: Germany
country: Greece
country: Hungary
country: Japan
country: Korea, Republic of
country: Latvia
country: Lithuania
country: Mexico
country: Poland
country: Portugal
country: Puerto Rico
country: Romania
country: Russian Federation
country: Slovakia
country: Slovenia
country: South Africa
country: Spain
country: Switzerland
country: Taiwan
country: United Kingdom
country: United States
country: Czech Republic
country: Netherlands
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Adalimumab
mesh term: Methotrexate
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: https://vivli.org/
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 