<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/NCT01711359</url>
  </required_header>
  <id_info>
    <org_study_id>14062</org_study_id>
    <secondary_id>I4V-MC-JADZ</secondary_id>
    <nct_id>NCT01711359</nct_id>
  </id_info>
  <brief_title>A Study in Participants With Moderate to Severe Rheumatoid Arthritis</brief_title>
  <acronym>RA-BEGIN</acronym>
  <official_title>A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment With Disease-Modifying Antirheumatic Drugs</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 therapy alone is noninferior to&#xD;
      methotrexate (MTX) therapy alone in the treatment of moderate to severe active rheumatoid&#xD;
      arthritis (RA) in those who have had limited or no treatment with MTX and are naive to other&#xD;
      conventional or biologic disease-modifying antirheumatic drugs (DMARDs).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">February 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 24</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 time point were deemed non-responders.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)</measure>
    <time_frame>Week 52</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 time point were deemed non-responders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>HAQ-DI 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 are averaged to calculate the HAQ-DI score, which ranges from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicates 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 24</time_frame>
    <description>Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of a composite score of the 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. DAS28 was calculated using the 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>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 (van der Heijde 2000). 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>Percentage of Participants Who Achieved a Simplified Disease Activity Index (SDAI) Score ≤3.3</measure>
    <time_frame>Week 24</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 50% (ACR50) Response</measure>
    <time_frame>Week 12, Week 24, Week 52</time_frame>
    <description>ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. &quot;ACR50 Responder&quot; is a participant who has at least 50% 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, 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response</measure>
    <time_frame>Week 12, Week 24, Week 52</time_frame>
    <description>ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. &quot;ACR70 Responder&quot; is a participant who has at least 70% 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, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinued study or drug or were rescued before analysis timepoint 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 24; Baseline, 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>Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)</measure>
    <time_frame>Baseline, Week 24; Baseline, Week 52</time_frame>
    <description>DAS28 consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), erythrocyte sedimentation rate (ESR) (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using the following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. 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/European League Against Rheumatism (ACR/EULAR) Remission</measure>
    <time_frame>Week 12, Week 24, Week 52</time_frame>
    <description>The ACR/EULAR definitions of RA remission include a &quot;Boolean-based definition&quot;. 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>Change From Baseline in Joint Space Narrowing and Bone Erosion Scores</measure>
    <time_frame>Baseline, Week 24; Baseline, 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. 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>Change From Baseline in Duration of Morning Joint Stiffness</measure>
    <time_frame>Baseline, Week 52</time_frame>
    <description>Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)</measure>
    <time_frame>Baseline, Week 24; Baseline Week 52</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;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Worst Joint Pain Numeric Rating Scale (NRS)</measure>
    <time_frame>Baseline, Week 24; Baseline Week 52</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;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mental Component Score (MCS) and 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 24; Baseline 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 (MCS and 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 24; Baseline 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 24; Baseline 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 Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores</measure>
    <time_frame>Baseline, Week 24; Baseline Week 52</time_frame>
    <description>The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a13-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 Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores</measure>
    <time_frame>Baseline, Week 24; Baseline 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>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 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 24; Week 32; Pre-dose</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">588</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Baricitinib + MTX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Baricitinib 4 milligram (mg) administered orally once daily through Week 52. Participants received methotrexate (MTX) orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</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. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MTX</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Baricitinib</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Baricitinib</arm_group_label>
    <arm_group_label>Baricitinib + MTX</arm_group_label>
    <other_name>LY3009104</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methotrexate</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Baricitinib + MTX</arm_group_label>
    <arm_group_label>MTX</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Baricitinib Placebo</intervention_name>
    <description>Baricitinib placebo administered orally once daily.</description>
    <arm_group_label>MTX</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MTX Placebo</intervention_name>
    <description>MTX placebo administered orally once weekly.</description>
    <arm_group_label>Baricitinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Folic Acid</intervention_name>
    <description>Administered orally every day</description>
    <arm_group_label>Baricitinib</arm_group_label>
    <arm_group_label>Baricitinib + MTX</arm_group_label>
    <arm_group_label>MTX</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a diagnosis of adult-onset rheumatoid arthritis (RA) as defined by American&#xD;
             College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 Criteria&#xD;
             for the Classification of RA&#xD;
&#xD;
          -  Have documented history of positive rheumatoid factor and/or cyclic citrullinated&#xD;
             peptide (CCP) antibody test&#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 ≥1.2 times the upper limit of normal (ULN)&#xD;
&#xD;
          -  Have had limited or no treatment with methotrexate (MTX)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have received conventional disease-modifying antirheumatic drugs (DMARDs) other than&#xD;
             MTX (eg, gold salts, cyclosporine, leflunomide, azathioprine, hydroxychloroquine,&#xD;
             sulfasalazine or any other immunosuppressives)&#xD;
&#xD;
          -  Are currently receiving corticosteroids at doses &gt;10 mg per day of prednisone (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;
          -  Have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry&#xD;
&#xD;
          -  Have ever received any biologic 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 (IV) injection within 2 weeks prior to study entry or within 6 weeks prior&#xD;
             to planned randomization or are anticipated to require a 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 active fibromyalgia that, in the investigator's opinion, would make it difficult&#xD;
             to appropriately assess RA activity for the purposes of this study&#xD;
&#xD;
          -  Have a diagnosis of any systemic inflammatory condition other than RA, such as, but&#xD;
             not limited to, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease,&#xD;
             ulcerative colitis, psoriatic arthritis, active vasculitis, or gout (Participants with&#xD;
             secondary Sjogren's syndrome are not excluded.)&#xD;
&#xD;
          -  Have a diagnosis of Felty's syndrome&#xD;
&#xD;
          -  Have had any major surgery within 8 weeks of study entry or will require major surgery&#xD;
             during the study that, in the opinion of the investigator in consultation with Lilly&#xD;
             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 an estimated Glomerular Filtration Rate (eGFR) based on the most recent available&#xD;
             serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of &lt;40&#xD;
             milliliter per minute per 1.73 m^2 (mL/min/1.73 m^2)&#xD;
&#xD;
          -  Have a history of chronic liver disease with the most recent available aspartate&#xD;
             aminotransferase (AST) or alanine aminotransferase (ALT) &gt;1.5 times the ULN or the&#xD;
             most recent available total bilirubin ≥1.5 times the ULN&#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, 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>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>Glendale</city>
        <state>Arizona</state>
        <zip>85304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
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        <country>Argentina</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>2000</zip>
        <country>Argentina</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>
      <address>
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        <zip>1646</zip>
        <country>Argentina</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>
      <address>
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        <zip>5400</zip>
        <country>Argentina</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>
      <address>
        <city>San Miguel De Tucuman</city>
        <zip>T4000AXL</zip>
        <country>Argentina</country>
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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>4000</zip>
        <country>Argentina</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>1100</zip>
        <country>Austria</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>1200</zip>
        <country>Belgium</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>3600</zip>
        <country>Belgium</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>9000</zip>
        <country>Belgium</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>4000</zip>
        <country>Belgium</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>7000</zip>
        <country>Belgium</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>80030-110</zip>
        <country>Brazil</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>74110-120</zip>
        <country>Brazil</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>04266-010</zip>
        <country>Brazil</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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        <state>Alberta</state>
        <zip>T5M 0H4</zip>
        <country>Canada</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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        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8V 3P9</zip>
        <country>Canada</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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        <state>Manitoba</state>
        <zip>R3A 1M3</zip>
        <country>Canada</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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        <state>Ontario</state>
        <zip>N2M 5N6</zip>
        <country>Canada</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>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 1A2</zip>
        <country>Canada</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>
      <address>
        <city>St. Catherines</city>
        <state>Ontario</state>
        <zip>L2N 7E4</zip>
        <country>Canada</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>
      <address>
        <city>Trois-Rivieres</city>
        <state>Quebec</state>
        <zip>G8Z 1Y2</zip>
        <country>Canada</country>
      </address>
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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>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7K 0H6</zip>
        <country>Canada</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>
      <address>
        <city>Bad Nauheim</city>
        <zip>61231</zip>
        <country>Germany</country>
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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>Bayreuth</city>
        <zip>95444</zip>
        <country>Germany</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>
      <address>
        <city>Berlin</city>
        <zip>13125</zip>
        <country>Germany</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>
      <address>
        <city>Gommern</city>
        <zip>39245</zip>
        <country>Germany</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>
      <address>
        <city>Hamburg</city>
        <zip>22081</zip>
        <country>Germany</country>
      </address>
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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>Munich</city>
        <zip>80336</zip>
        <country>Germany</country>
      </address>
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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>Ampelokipoi</city>
        <zip>11527</zip>
        <country>Greece</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>71110</zip>
        <country>Greece</country>
      </address>
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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>Kifissia</city>
        <zip>14561</zip>
        <country>Greece</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>Larissa</city>
        <zip>41221</zip>
        <country>Greece</country>
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    </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>Ahmedabad</city>
        <zip>532004</zip>
        <country>India</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>Attavar, Mangalore</city>
        <zip>575001</zip>
        <country>India</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>Bangalore</city>
        <zip>560 054</zip>
        <country>India</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>Belgaum</city>
        <zip>590 010</zip>
        <country>India</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>Hyderabaad</city>
        <zip>500072</zip>
        <country>India</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>302006</zip>
        <country>India</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>700 020</zip>
        <country>India</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>226 014</zip>
        <country>India</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>400053</zip>
        <country>India</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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        <city>New Delhi</city>
        <zip>110 076</zip>
        <country>India</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>Firenze</city>
        <zip>50139</zip>
        <country>Italy</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>
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        <zip>16132</zip>
        <country>Italy</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>
      <address>
        <city>Milano</city>
        <zip>20157</zip>
        <country>Italy</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>20900</zip>
        <country>Italy</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>
      <address>
        <city>Torino</city>
        <zip>10154</zip>
        <country>Italy</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>
      <address>
        <city>Valeggio Sul Mincio</city>
        <zip>37067</zip>
        <country>Italy</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>
      <address>
        <city>Aichi</city>
        <zip>466-8560</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>
      <address>
        <city>Chiba</city>
        <zip>284-0003</zip>
        <country>Japan</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>
      <address>
        <city>Fukuoka</city>
        <zip>807-8556</zip>
        <country>Japan</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>
      <address>
        <city>Hiroshima</city>
        <zip>733-0032</zip>
        <country>Japan</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>
      <address>
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        <zip>063-0811</zip>
        <country>Japan</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>
      <address>
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        <zip>665-0827</zip>
        <country>Japan</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>
      <address>
        <city>Ibaragi</city>
        <zip>316-0015</zip>
        <country>Japan</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>Iwate</city>
        <zip>020-0015</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>Japan</city>
        <zip>275-8580</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>Kagawa</city>
        <zip>761-0793</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>Kagoshima</city>
        <zip>899-5117</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>Kanagawa</city>
        <zip>236-0004</zip>
        <country>Japan</country>
      </address>
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  </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>Kumamoto</city>
        <zip>861-1196</zip>
        <country>Japan</country>
      </address>
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  </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>Mie</city>
        <zip>510-0016</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>Nagano</city>
        <zip>380-8582</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>Nagasaki</city>
        <zip>857-1195</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>Niigata</city>
        <zip>940-2085</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>Okayama</city>
        <zip>700-8607</zip>
        <country>Japan</country>
      </address>
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  </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>Okinawa</city>
        <zip>901-0243</zip>
        <country>Japan</country>
      </address>
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  </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>359-1111</zip>
        <country>Japan</country>
      </address>
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  </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>430-8558</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>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>Incheon</city>
        <zip>405-760</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>Seoul</city>
        <zip>134-727</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>Guadalajara</city>
        <zip>44620</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>Monterrey</city>
        <zip>64040</zip>
        <country>Mexico</country>
      </address>
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  </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>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>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>Caguas</city>
        <zip>00725</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>Carolina</city>
        <zip>00983</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>San German</city>
        <zip>00683</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>San Juan</city>
        <zip>00927</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>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>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>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>Bloemfontein</city>
        <zip>9301</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>Durban</city>
        <zip>4092</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>Somerset West</city>
        <zip>7135</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>Göteborg</city>
        <zip>SE 413 45</zip>
        <country>Sweden</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>Huddinge</city>
        <zip>141 87</zip>
        <country>Sweden</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>Malmo</city>
        <zip>SE-20502</zip>
        <country>Sweden</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>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 0QQ</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>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>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>North Shields</city>
        <state>Tyneside</state>
        <zip>NE29 8NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>India</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Portugal</country>
    <country>Puerto Rico</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 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 19, 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>Folic Acid</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 Week 24.&#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>Methotrexate</title>
          <description>Methotrexate (MTX) administered orally once weekly with dose ranging from 10 to 20 milligram (mg) per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
        </group>
        <group group_id="P2">
          <title>Baricitinib</title>
          <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
        </group>
        <group group_id="P3">
          <title>Baricitinib + MTX</title>
          <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="213"/>
                <participants group_id="P2" count="160"/>
                <participants group_id="P3" count="215"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least One Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="210"/>
                <participants group_id="P2" count="159"/>
                <participants group_id="P3" count="215"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Rescued</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="161"/>
                <participants group_id="P2" count="136"/>
                <participants group_id="P3" count="173"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="42"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="24"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <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="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="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized, Not Treated</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Follow Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25">Participants from treatment who entered the post-treatment follow-up period.</participants>
                <participants group_id="P2" count="15">Participants from treatment who entered the post-treatment follow-up period.</participants>
                <participants group_id="P3" count="28">Participants from treatment and rescue who entered the post-treatment follow-up period.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="28"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Methotrexate</title>
          <description>Methotrexate (MTX) administered orally once weekly with dose ranging from 10 to 20 milligram (mg) per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
        </group>
        <group group_id="B2">
          <title>Baricitinib</title>
          <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
        </group>
        <group group_id="B3">
          <title>Baricitinib + MTX</title>
          <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</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="210"/>
            <count group_id="B2" value="159"/>
            <count group_id="B3" value="215"/>
            <count group_id="B4" value="584"/>
          </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="50.5" spread="13.4"/>
                    <measurement group_id="B2" value="50.9" spread="13.0"/>
                    <measurement group_id="B3" value="48.5" spread="13.5"/>
                    <measurement group_id="B4" value="49.9" spread="13.4"/>
                  </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="148"/>
                    <measurement group_id="B2" value="121"/>
                    <measurement group_id="B3" value="156"/>
                    <measurement group_id="B4" value="425"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="59"/>
                    <measurement group_id="B4" value="159"/>
                  </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="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="61"/>
                    <measurement group_id="B4" value="165"/>
                  </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="10"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="128"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="123"/>
                    <measurement group_id="B4" value="349"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_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="41"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Austria</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>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Brazil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="20"/>
                  </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="5"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Greece</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>India</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mexico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="46"/>
                  </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="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russian Federation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Africa</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Korea, Republic of</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sweden</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Rheumatoid Arthritis</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.2" lower_limit="0.1" upper_limit="0.6"/>
                    <measurement group_id="B2" value="0.2" lower_limit="0.1" upper_limit="1.1"/>
                    <measurement group_id="B3" value="0.2" lower_limit="0.1" upper_limit="1.0"/>
                    <measurement group_id="B4" value="0.2" lower_limit="0.1" upper_limit="0.8"/>
                  </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="26.5" spread="14.8"/>
                    <measurement group_id="B2" value="26.4" spread="14.1"/>
                    <measurement group_id="B3" value="27.7" spread="14.5"/>
                    <measurement group_id="B4" value="26.9" spread="14.5"/>
                  </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="16.4" spread="10.6"/>
                    <measurement group_id="B2" value="16.1" spread="9.2"/>
                    <measurement group_id="B3" value="16.3" spread="9.5"/>
                    <measurement group_id="B4" value="16.3" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>High sensitivity C-reactive protein</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="22.34" spread="21.78"/>
                    <measurement group_id="B2" value="23.75" spread="26.24"/>
                    <measurement group_id="B3" value="24.27" spread="29.42"/>
                    <measurement group_id="B4" value="23.44" spread="25.98"/>
                  </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 time point were deemed non-responders.</description>
        <time_frame>Week 24</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>Methotrexate</title>
            <description>MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib + MTX</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</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 time point 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>Percent of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="210"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="215"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.9"/>
                    <measurement group_id="O2" value="76.7"/>
                    <measurement group_id="O3" value="78.1"/>
                  </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>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>Noninferiority is concluded if the lower bound of the 95% CI for the difference in response rate is &gt;-12%</non_inferiority_desc>
            <param_type>Newcombe-Wilson method</param_type>
            <param_value>14.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.5</ci_lower_limit>
            <ci_upper_limit>24.1</ci_upper_limit>
            <estimate_desc>Estimation Parameter: Newcombe-Wilson method without continuity correction for difference in the response rate (Baricitinib minus Methotrexate).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</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 time point were deemed non-responders.</description>
        <time_frame>Week 52</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>Methotrexate</title>
            <description>MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib + MTX</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</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 time point 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>Percent of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="210"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="215"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.7"/>
                    <measurement group_id="O2" value="73.0"/>
                    <measurement group_id="O3" value="72.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score</title>
        <description>HAQ-DI 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 are averaged to calculate the HAQ-DI score, which ranges from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicates an improvement in the participant's condition.</description>
        <time_frame>Baseline, Week 24</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 modified baseline observation carried forward (mBOCF).</population>
        <group_list>
          <group group_id="O1">
            <title>Methotrexate</title>
            <description>MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib + MTX</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score</title>
          <description>HAQ-DI 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 are averaged to calculate the HAQ-DI score, which ranges from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicates an improvement in the participant's condition.</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 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="210"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="215"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.73" spread="0.71"/>
                    <measurement group_id="O2" value="-1.01" spread="0.74"/>
                    <measurement group_id="O3" value="-0.92" spread="0.74"/>
                  </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 a composite score of the 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. DAS28 was calculated using the 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 24</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 mBOCF.</population>
        <group_list>
          <group group_id="O1">
            <title>Methotrexate</title>
            <description>MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib + MTX</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</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 a composite score of the 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. DAS28 was calculated using the 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: 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 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="210"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="215"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.01" spread="1.51"/>
                    <measurement group_id="O2" value="-2.74" spread="1.39"/>
                    <measurement group_id="O3" value="-2.82" spread="1.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </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 (van der Heijde 2000). 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>Methotrexate</title>
            <description>MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib + MTX</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</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 (van der Heijde 2000). 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="191"/>
                <count group_id="O2" value="152"/>
                <count group_id="O3" value="198"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.64" spread="1.81"/>
                    <measurement group_id="O2" value="0.43" spread="1.18"/>
                    <measurement group_id="O3" value="0.32" spread="1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a 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 24</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>Methotrexate</title>
            <description>MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib + MTX</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a 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="210"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="215"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5"/>
                    <measurement group_id="O2" value="22.0"/>
                    <measurement group_id="O3" value="22.8"/>
                  </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) Response</title>
        <description>ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. &quot;ACR50 Responder&quot; is a participant who has at least 50% 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, 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.</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>Methotrexate</title>
            <description>MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib + MTX</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response</title>
          <description>ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. &quot;ACR50 Responder&quot; is a participant who has at least 50% 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, 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.</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>Percent of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="210"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="215"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.9"/>
                    <measurement group_id="O2" value="54.7"/>
                    <measurement group_id="O3" value="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.3"/>
                    <measurement group_id="O2" value="59.7"/>
                    <measurement group_id="O3" value="63.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.6"/>
                    <measurement group_id="O2" value="57.2"/>
                    <measurement group_id="O3" value="61.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response</title>
        <description>ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. &quot;ACR70 Responder&quot; is a participant who has at least 70% 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, HAQ-DI, pain due to arthritis, and 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, 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>Methotrexate</title>
            <description>MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib + MTX</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response</title>
          <description>ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. &quot;ACR70 Responder&quot; is a participant who has at least 70% 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, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinued study or drug or were rescued before analysis timepoint were deemed non-responders.</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>Percent of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="210"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="215"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.7"/>
                    <measurement group_id="O2" value="30.8"/>
                    <measurement group_id="O3" value="33.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.4"/>
                    <measurement group_id="O2" value="42.1"/>
                    <measurement group_id="O3" value="39.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.2"/>
                    <measurement group_id="O2" value="42.1"/>
                    <measurement group_id="O3" value="46.0"/>
                  </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 24; Baseline, 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 modified last observation carried forward (mLOCF).</population>
        <group_list>
          <group group_id="O1">
            <title>Methotrexate</title>
            <description>MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib + MTX</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</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 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="200"/>
                <count group_id="O2" value="157"/>
                <count group_id="O3" value="208"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.12" spread="16.12"/>
                    <measurement group_id="O2" value="-28.20" spread="13.96"/>
                    <measurement group_id="O3" value="-29.86" spread="14.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.95" spread="18.07"/>
                    <measurement group_id="O2" value="-28.94" spread="14.58"/>
                    <measurement group_id="O3" value="-30.72" spread="14.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)</title>
        <description>DAS28 consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), erythrocyte sedimentation rate (ESR) (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using the following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.</description>
        <time_frame>Baseline, Week 24; Baseline, 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>Methotrexate</title>
            <description>MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib + MTX</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)</title>
          <description>DAS28 consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), erythrocyte sedimentation rate (ESR) (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using the following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.</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="203"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.20" spread="1.53"/>
                    <measurement group_id="O2" value="-2.76" spread="1.45"/>
                    <measurement group_id="O3" value="-3.06" spread="1.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.32" spread="1.77"/>
                    <measurement group_id="O2" value="-2.84" spread="1.57"/>
                    <measurement group_id="O3" value="-3.22" spread="1.48"/>
                  </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</title>
        <description>The ACR/EULAR definitions of RA remission include a &quot;Boolean-based definition&quot;. 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>Methotrexate</title>
            <description>MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib + MTX</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission</title>
          <description>The ACR/EULAR definitions of RA remission include a &quot;Boolean-based definition&quot;. 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="210"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="215"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7"/>
                    <measurement group_id="O2" value="13.8"/>
                    <measurement group_id="O3" value="14.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6"/>
                    <measurement group_id="O2" value="18.9"/>
                    <measurement group_id="O3" value="16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4"/>
                    <measurement group_id="O2" value="17.0"/>
                    <measurement group_id="O3" value="20.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Joint Space Narrowing 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. 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; Baseline, 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>Methotrexate</title>
            <description>MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib + MTX</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Joint Space Narrowing 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. 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="210"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="215"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>JSN Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                    <count group_id="O2" value="152"/>
                    <count group_id="O3" value="198"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.15" spread="0.94"/>
                    <measurement group_id="O2" value="0.08" spread="0.44"/>
                    <measurement group_id="O3" value="0.05" spread="0.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>JSN Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="192"/>
                    <count group_id="O2" value="154"/>
                    <count group_id="O3" value="199"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.23" spread="1.00"/>
                    <measurement group_id="O2" value="0.26" spread="1.14"/>
                    <measurement group_id="O3" value="0.08" spread="0.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bone Erosion Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                    <count group_id="O2" value="152"/>
                    <count group_id="O3" value="198"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.49" spread="1.14"/>
                    <measurement group_id="O2" value="0.35" spread="0.92"/>
                    <measurement group_id="O3" value="0.27" spread="0.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bone Erosion Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="192"/>
                    <count group_id="O2" value="154"/>
                    <count group_id="O3" value="199"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.80" spread="1.80"/>
                    <measurement group_id="O2" value="0.55" spread="1.48"/>
                    <measurement group_id="O3" value="0.33" spread="1.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Duration of Morning Joint Stiffness</title>
        <description>Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.</description>
        <time_frame>Baseline, 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>Methotrexate</title>
            <description>MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib + MTX</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Duration of Morning Joint Stiffness</title>
          <description>Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. 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 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>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="204"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-40.0" lower_limit="-55.0" upper_limit="-30.0"/>
                    <measurement group_id="O2" value="-55.0" lower_limit="-60.0" upper_limit="-40.0"/>
                    <measurement group_id="O3" value="-60.0" lower_limit="-80.0" upper_limit="-50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)</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;.</description>
        <time_frame>Baseline, Week 24; Baseline 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>Methotrexate</title>
            <description>MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib + MTX</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)</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;.</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="204"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.2" spread="2.7"/>
                    <measurement group_id="O2" value="-3.0" spread="3.1"/>
                    <measurement group_id="O3" value="-3.0" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.3" spread="2.8"/>
                    <measurement group_id="O2" value="-2.9" spread="3.1"/>
                    <measurement group_id="O3" value="-3.0" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Worst Joint Pain Numeric Rating Scale (NRS)</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;.</description>
        <time_frame>Baseline, Week 24; Baseline 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>Methotrexate</title>
            <description>MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib + MTX</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Worst Joint Pain Numeric Rating Scale (NRS)</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;.</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="204"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.8" spread="2.5"/>
                    <measurement group_id="O2" value="-3.9" spread="2.7"/>
                    <measurement group_id="O3" value="-3.9" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.0" spread="2.8"/>
                    <measurement group_id="O2" value="-3.9" spread="2.9"/>
                    <measurement group_id="O3" value="-4.1" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mental Component Score (MCS) and 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 (MCS and 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 24; Baseline 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>Methotrexate</title>
            <description>MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib + MTX</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mental Component Score (MCS) and 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 (MCS and 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="202"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="207"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MCS Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="10.8"/>
                    <measurement group_id="O2" value="5.9" spread="11.7"/>
                    <measurement group_id="O3" value="4.6" 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="2.4" spread="10.9"/>
                    <measurement group_id="O2" value="5.8" spread="11.9"/>
                    <measurement group_id="O3" value="5.0" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PCS Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.4" spread="9.2"/>
                    <measurement group_id="O2" value="12.5" spread="9.1"/>
                    <measurement group_id="O3" value="13.2" spread="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PCS Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.4" spread="10.1"/>
                    <measurement group_id="O2" value="11.6" spread="9.6"/>
                    <measurement group_id="O3" value="13.3" spread="9.8"/>
                  </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 24; Baseline 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>Methotrexate</title>
            <description>MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib + MTX</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</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="202"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="207"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Index Score (US Algorithm) Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.142" spread="0.189"/>
                    <measurement group_id="O2" value="0.197" spread="0.164"/>
                    <measurement group_id="O3" value="0.194" spread="0.180"/>
                  </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="0.138" spread="0.203"/>
                    <measurement group_id="O2" value="0.186" spread="0.177"/>
                    <measurement group_id="O3" value="0.185" spread="0.186"/>
                  </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="0.205" spread="0.274"/>
                    <measurement group_id="O2" value="0.285" spread="0.241"/>
                    <measurement group_id="O3" value="0.282" spread="0.255"/>
                  </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="0.197" spread="0.294"/>
                    <measurement group_id="O2" value="0.271" spread="0.258"/>
                    <measurement group_id="O3" value="0.268" spread="0.266"/>
                  </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 24; Baseline 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>Methotrexate</title>
            <description>MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib + MTX</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</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="202"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="207"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Self-Perceived Health Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.5" spread="28.3"/>
                    <measurement group_id="O2" value="24.1" spread="26.0"/>
                    <measurement group_id="O3" value="21.4" spread="31.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-Perceived Health Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.6" spread="30.1"/>
                    <measurement group_id="O2" value="24.5" spread="28.7"/>
                    <measurement group_id="O3" value="24.5" spread="30.6"/>
                  </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) Scores</title>
        <description>The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a13-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 24; Baseline 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>Methotrexate</title>
            <description>MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib + MTX</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores</title>
          <description>The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a13-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="204"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.3" spread="11.2"/>
                    <measurement group_id="O2" value="13.0" spread="10.8"/>
                    <measurement group_id="O3" value="12.3" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1" spread="10.9"/>
                    <measurement group_id="O2" value="11.3" spread="10.8"/>
                    <measurement group_id="O3" value="12.6" spread="11.8"/>
                  </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 24; Baseline Week 52</time_frame>
        <population>mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and an observed value at the time point being summarized.</population>
        <group_list>
          <group group_id="O1">
            <title>Methotrexate</title>
            <description>MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O2">
            <title>Baricitinib</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
          </group>
          <group group_id="O3">
            <title>Baricitinib + MTX</title>
            <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</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: all randomized participants who received at least 1 dose of 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="210"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="215"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Absenteeism Week 24 (n=76, 56, 90)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.6" spread="35.5"/>
                    <measurement group_id="O2" value="-8.7" spread="30.4"/>
                    <measurement group_id="O3" value="-7.6" spread="26.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absenteeism Week 52 (n=52, 51, 71)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.0" spread="29.2"/>
                    <measurement group_id="O2" value="-8.4" spread="29.7"/>
                    <measurement group_id="O3" value="-7.3" spread="21.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Presenteeism Week 24(n=70, 51, 86)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19" spread="25"/>
                    <measurement group_id="O2" value="-26" spread="27"/>
                    <measurement group_id="O3" value="-32" spread="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Presenteeism Week 52 (n=51, 47, 75)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26" spread="26"/>
                    <measurement group_id="O2" value="-27" spread="24"/>
                    <measurement group_id="O3" value="-33" spread="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work Productivity Loss Week 24 (n=70, 71, 86)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.8" spread="30.2"/>
                    <measurement group_id="O2" value="-25.6" spread="29.1"/>
                    <measurement group_id="O3" value="-30.9" spread="29.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work Productivity Loss Week 52 (n=51, 47, 75)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.1" spread="30.5"/>
                    <measurement group_id="O2" value="-27.6" spread="27.3"/>
                    <measurement group_id="O3" value="-33.8" spread="27.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity Impairment Week 24 (n=184, 145, 192)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25" spread="26"/>
                    <measurement group_id="O2" value="-36" spread="28"/>
                    <measurement group_id="O3" value="-31" spread="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity Impairment Week 52 (n=141, 131, 172)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28" spread="27"/>
                    <measurement group_id="O2" value="-34" spread="27"/>
                    <measurement group_id="O3" value="-37" spread="27"/>
                  </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 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. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</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="355"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135" spread="23.1"/>
                  </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 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. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</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/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="355"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1280" spread="47.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>All enrolled participants including those receiving rescue therapy, with events occurring after rescue accounted separately. Rescue therapy occurred at Week 24 or later, if determined to be nonresponders (lack of improvement of at least 20% in both tender joint count and swollen joint count).</desc>
      <group_list>
        <group group_id="E1">
          <title>Methotrexate</title>
          <description>Methotrexate (MTX) administered orally once weekly with dose ranging from 10 to 20 milligram (mg) per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
        </group>
        <group group_id="E2">
          <title>Baricitinib</title>
          <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
        </group>
        <group group_id="E3">
          <title>Baricitinib + MTX</title>
          <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.</description>
        </group>
        <group group_id="E4">
          <title>Rescue Period</title>
          <description>Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52.</description>
        </group>
        <group group_id="E5">
          <title>Methotrexate - 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="E6">
          <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.</description>
        </group>
        <group group_id="E7">
          <title>Baricitinib + MTX - Follow-up</title>
          <description>No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug. Includes participants who were rescued to Baricitinib + MTX.</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="20" subjects_at_risk="210"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="215"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Gastric ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Drowning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute hepatitis B</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Bronchitis haemophilus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Campylobacter gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Escherichia sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Infectious colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Meningitis bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cervix carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Gallbladder adenosquamous carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </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="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Genital prolapse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pulmonary fibrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </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="115" subjects_at_risk="210"/>
                <counts group_id="E2" subjects_affected="81" subjects_at_risk="159"/>
                <counts group_id="E3" subjects_affected="129" subjects_at_risk="215"/>
                <counts group_id="E4" subjects_affected="21" subjects_at_risk="39"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="28"/>
              </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="2" subjects_affected="2" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="159"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Thrombocytosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="159"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiomegaly</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Left ventricular hypertrophy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Scleritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Scleromalacia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="159"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="210"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="15" subjects_affected="12" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="159"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="159"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="16" subjects_affected="13" subjects_at_risk="210"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="159"/>
                <counts group_id="E3" events="26" subjects_affected="20" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="210"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="159"/>
                <counts group_id="E3" events="8" subjects_affected="5" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="159"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Hepatitis E</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="159"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="20" subjects_affected="17" subjects_at_risk="210"/>
                <counts group_id="E2" events="21" subjects_affected="16" subjects_at_risk="159"/>
                <counts group_id="E3" events="32" subjects_affected="21" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="159"/>
                <counts group_id="E3" events="9" subjects_affected="7" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="210"/>
                <counts group_id="E2" events="14" subjects_affected="12" subjects_at_risk="159"/>
                <counts group_id="E3" events="19" subjects_affected="16" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="210"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="159"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="210"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="159"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="210"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="159"/>
                <counts group_id="E3" events="11" subjects_affected="11" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="210"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="159"/>
                <counts group_id="E3" events="16" subjects_affected="14" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="148"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="8" subjects_affected="6" subjects_at_risk="156"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </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="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </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="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="15" subjects_affected="13" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="210"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="159"/>
                <counts group_id="E3" events="11" subjects_affected="10" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Lymphocyte count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="210"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="210"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="159"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="159"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dyslipidaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="159"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </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="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="159"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="159"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="159"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="210"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="159"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pregnancy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="210"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="159"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Polyuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Catarrh</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="210"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="159"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Eczema asteatotic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Miliaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Seborrhoeic dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="215"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="159"/>
                <counts group_id="E3" events="13" subjects_affected="13" subjects_at_risk="215"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </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/NCT01711359
org study id: 14062
secondary id: I4V-MC-JADZ
nct id: NCT01711359
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether baricitinib therapy alone is noninferior to
      methotrexate (MTX) therapy alone in the treatment of moderate to severe active rheumatoid
      arthritis (RA) in those who have had limited or no treatment with MTX and are naive to other
      conventional or biologic disease-modifying antirheumatic drugs (DMARDs).
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 24
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 time point were deemed non-responders.
measure: Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)
time frame: Week 52
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 time point were deemed non-responders.
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
time frame: Baseline, Week 24
description: HAQ-DI 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 are averaged to calculate the HAQ-DI score, which ranges from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicates 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 24
description: Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of a composite score of the 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. DAS28 was calculated using the 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: 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 (van der Heijde 2000). 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: Percentage of Participants Who Achieved a Simplified Disease Activity Index (SDAI) Score ≤3.3
time frame: Week 24
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 50% (ACR50) Response
time frame: Week 12, Week 24, Week 52
description: ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. "ACR50 Responder" is a participant who has at least 50% 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, 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: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
time frame: Week 12, Week 24, Week 52
description: ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. "ACR70 Responder" is a participant who has at least 70% 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, HAQ-DI, pain due to arthritis, and 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 Clinical Disease Activity Index (CDAI) Score
time frame: Baseline, Week 24; Baseline, 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: Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
time frame: Baseline, Week 24; Baseline, Week 52
description: DAS28 consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), erythrocyte sedimentation rate (ESR) (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using the following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.
measure: Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission
time frame: Week 12, Week 24, Week 52
description: The ACR/EULAR definitions of RA remission include 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: Change From Baseline in Joint Space Narrowing and Bone Erosion Scores
time frame: Baseline, Week 24; Baseline, 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: Change From Baseline in Duration of Morning Joint Stiffness
time frame: Baseline, Week 52
description: Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
measure: Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)
time frame: Baseline, Week 24; Baseline Week 52
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".
measure: Change From Baseline in Worst Joint Pain Numeric Rating Scale (NRS)
time frame: Baseline, Week 24; Baseline Week 52
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".
measure: Change From Baseline in Mental Component Score (MCS) and 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 24; Baseline 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 (MCS and 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 24; Baseline 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 24; Baseline 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 Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores
time frame: Baseline, Week 24; Baseline Week 52
description: The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a13-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 Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
time frame: Baseline, Week 24; Baseline 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: 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 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 24; Week 32; Pre-dose
arm group label: Baricitinib + MTX
arm group type: Experimental
description: Baricitinib 4 milligram (mg) administered orally once daily through Week 52. Participants received methotrexate (MTX) orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
arm group label: Baricitinib
arm group type: Experimental
description: Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
arm group label: MTX
arm group type: Active Comparator
description: MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
intervention type: Drug
intervention name: Baricitinib
description: Administered orally
arm group label: Baricitinib
arm group label: Baricitinib + MTX
other name: LY3009104
intervention type: Drug
intervention name: Methotrexate
description: Administered orally
arm group label: Baricitinib + MTX
arm group label: MTX
intervention type: Drug
intervention name: Baricitinib Placebo
description: Baricitinib placebo administered orally once daily.
arm group label: MTX
intervention type: Drug
intervention name: MTX Placebo
description: MTX placebo administered orally once weekly.
arm group label: Baricitinib
intervention type: Drug
intervention name: Folic Acid
description: Administered orally every day
arm group label: Baricitinib
arm group label: Baricitinib + MTX
arm group label: MTX
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
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country: Argentina
country: Austria
country: Belgium
country: Brazil
country: Canada
country: Germany
country: Greece
country: India
country: Italy
country: Japan
country: Korea, Republic of
country: Mexico
country: Portugal
country: Puerto Rico
country: Russian Federation
country: South Africa
country: Sweden
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Folic Acid
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: 
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certain agreements: 
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