<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/NCT02975336</url>
  </required_header>
  <id_info>
    <org_study_id>MS200527-0018</org_study_id>
    <secondary_id>2016-002950-19</secondary_id>
    <nct_id>NCT02975336</nct_id>
  </id_info>
  <brief_title>A Phase II Study of M2951 in SLE</brief_title>
  <official_title>A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With SLE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EMD Serono Research &amp; Development Institute, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck KGaA, Darmstadt, Germany</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>EMD Serono</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      M2951 is an investigational drug under evaluation for treatment of autoimmune and&#xD;
      inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of&#xD;
      M2951 in participants with Systemic Lupus Erythematosus (SLE).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study is completed; primary analysis completed.&#xD;
  </why_stopped>
  <start_date type="Actual">January 4, 2017</start_date>
  <completion_date type="Actual">March 23, 2020</completion_date>
  <primary_completion_date type="Actual">November 27, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52</measure>
    <time_frame>Week 52</time_frame>
    <description>SRI-4 response was defined as greater than or equal to (&gt;=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE) divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52</measure>
    <time_frame>Week 52</time_frame>
    <description>SRI-6 response was defined as &gt;= 6-point reduction in SLEDAI-2K total score, no new BILAG A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system :A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)</measure>
    <time_frame>Baseline up to Week 56</time_frame>
    <description>Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs: events between first dose of study drug that were absent before treatment/that worsened relative to pre-treatment state up to 56 weeks. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs and serious TEAEs were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)</measure>
    <time_frame>Baseline up to Week 56</time_frame>
    <description>Severity of TEAEs were graded using NCI-CTCAE v4.03 toxicity grades, as follows: Grade 1= Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening and Grade 5 = Death. Number of participants with TEAEs by severity were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs</measure>
    <time_frame>Baseline up to Week 56</time_frame>
    <description>Vital signs included body temperature, systolic and diastolic blood pressure, pulse rate, respiratory rate, weight and height. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in vital signs were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Findings</measure>
    <time_frame>Baseline up to Week 56</time_frame>
    <description>12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. The corrected QT interval (QTcF) was calculated using Fridericia's formula. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semisupine position. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters</measure>
    <time_frame>Baseline up to Week 56</time_frame>
    <description>Laboratory investigation included hematology, biochemistry, urinalysis and coagulation. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in laboratory parameters were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2</measure>
    <time_frame>Week 2</time_frame>
    <description>Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 4.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 12.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 24.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36</measure>
    <time_frame>Week 36</time_frame>
    <description>Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 36.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52</measure>
    <time_frame>Week 52</time_frame>
    <description>Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 52</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56</measure>
    <time_frame>Week 56</time_frame>
    <description>Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 56</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Mean Absolute Total B Cell Count at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>Mean total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Mean Absolute Total B Cell Count at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Mean Absolute Total B Cell Count at Week 52</measure>
    <time_frame>Week 52</time_frame>
    <description>Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Mean Absolute Total B Cell Count at Week 56</measure>
    <time_frame>Week 56</time_frame>
    <description>Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2</measure>
    <time_frame>Baseline and Week 2</time_frame>
    <description>Change from baseline in the serum levels of IgG, IgA, IgM were assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4</measure>
    <time_frame>Baseline and Week 4</time_frame>
    <description>Change from baseline in the serum levels of IgG, IgA, IgM were assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>Change from baseline in the serum levels of IgG, IgA, IgM were assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>Change from baseline in the serum levels of IgG, IgA, IgM were assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36</measure>
    <time_frame>Baseline and Week 36</time_frame>
    <description>Change from baseline in the serum levels of IgG, IgA, IgM were assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52</measure>
    <time_frame>Baseline and Week 52</time_frame>
    <description>Change from baseline in the serum levels of IgG, IgA, IgM were assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56</measure>
    <time_frame>Baseline and Week 56</time_frame>
    <description>Change from baseline in the serum levels of IgG, IgA, IgM were assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Change From Baseline in Total B Cell Count at Week 4</measure>
    <time_frame>Baseline and Week 4</time_frame>
    <description>Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Change From Baseline in Total B Cell Count at Week 24</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Change From Baseline in Total B Cell Count at Week 52</measure>
    <time_frame>Baseline and Week 52</time_frame>
    <description>Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DBPC Period: Change From Baseline in Total B Cell Count at Week 56</measure>
    <time_frame>Baseline and Week 56</time_frame>
    <description>Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Time to First Severe British Isles Lupus Assessment Group (BILAG) A Flare</measure>
    <time_frame>Baseline up to Week 56</time_frame>
    <description>BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). Total BILAG score is sum of scores of 9 domains where A=12, B=8, C=1, D=0, and E=0. Total score ranges from 0 to 108 with a higher score indicating greater lupus activity. Time to first severe flare, where a severe flare is defined as at least one BILAG A (Severe disease activity) score in any organ system due to items that are new or worse, compared to the BILAG evaluation at the previous visit, during the 52-Week Treatment. It was measured using Kaplan-Meier (KM) estimates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52 in Serologically Active (SA) Subgroup</measure>
    <time_frame>Week 52</time_frame>
    <description>SRI-4 response was defined as greater than or equal to (&gt;=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52 in Serologically Active Subgroup</measure>
    <time_frame>Week 52</time_frame>
    <description>SRI-6 response was defined as &gt;= 6-point reduction in SLEDAI-2K total score, no new BILAG A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system :A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale = from 0(very well) to 100(very poor).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Time to First British Isles Lupus Assessment Group (BILAG) A or 2B Moderate to Severe Flare</measure>
    <time_frame>Baseline up to Week 56</time_frame>
    <description>BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). Total BILAG score is sum of scores of 9 domains where A=12, B=8, C=1, D=0, and E=0. Total score ranges from 0 to 108 with a higher score indicating greater lupus activity. A Moderate to Severe (BILAG A or 2B) flare is defined as at least one BILAG A (severe disease activity) grade or two BILAG B (moderate disease activity) grade in any organ system due to items that are new or worse, compared to the BILAG evaluation at the previous visit, during the 52 week treatment. It was measured using Kaplan-Meier (KM) estimates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Number of Participants With British Isles Lupus Assessment Group (BILAG) 2004 Flare-Free Status During the 52-Week Treatment Period</measure>
    <time_frame>up to Week 52</time_frame>
    <description>A participant has a flare-free status if no flare has been reported during the 52-week treatment period. Participants who discontinued treatment prior to Week 52, without having a flare are counted as not being flare free at Week 52. A flare was defined as either 1 or more new BILAG-2004 A (severe disease activity) or 2 or more new BILAG-2004 B (moderate disease activity) items compared to the previous visit. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Annualized Flare Rate</measure>
    <time_frame>Baseline up to Week 52</time_frame>
    <description>A flare was defined as either 1 or more new BILAG-2004 A (severe disease activity) or 2 or more new BILAG-2004 B (moderate disease activity) items compared to the previous visit. The occurrence of a new flare was checked for each available visit versus the previous available visit up to Week 52. If no new flares occurred, the number of flares was set to 0. Otherwise all flares were counted leading to the maximum number of flares of 13. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25 (1 year). The flare exposure time is the time up to Week 52 (date of BILAG-2004 assessment at Week 52) or up to the date of last available BILAG 2004 assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (&lt;= ) 2 at Week 52</measure>
    <time_frame>Week 52</time_frame>
    <description>Low disease activity is defined as SLEDAI-2K score &lt;=2. SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 30 days. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Clinical Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (&lt;= ) 2 at Week 52</measure>
    <time_frame>Week 52</time_frame>
    <description>Low disease activity is defined as SLEDAI-2K score &lt;=2. SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 30 days. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms). Clinical SLEDAI-2K score is equal to the SLEDAI-2K score from electronic case report form (eCRF) excluding the components 'Increased Deoxyribonucleic acid (DNA) Binding' and 'Low Complement'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</measure>
    <time_frame>Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</time_frame>
    <description>SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 30 days. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</measure>
    <time_frame>Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</time_frame>
    <description>CLASI is an validated measurement instrument for lupus erythematosus developed for use in clinical studies that consists of separate scores for the activity of the disease (CLASI-A). The CLASI activity score is calculated on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI activity score ranges from 0-70, with higher scores indicating more severe skin disease. Severity categories based on the CLASI activity score are as follows: mild (0-9), moderate (10-20), and severe (21-70).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Number of Participants With Response Based on BILAG-Based Composite Lupus Assessment (BICLA) at Week 52</measure>
    <time_frame>Week 52</time_frame>
    <description>BICLA response defined as participants meeting following criteria: [1] At least one gradation of improvement in baseline BILAG scores in all body systems with moderate or severe disease activity at entry (example: all A (severe disease) scores falling to B (moderate), C (mild), or D (no activity) and all B scores falling to C or D; [2] No new BILAG A or more than one new BILAG B scores; [3] No worsening of total SLEDAI-2K score from baseline; [4] No significant deterioration (=&lt;10%) in physician's global assessment and [5] No treatment failure (initiation of non-protocol treatment).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</measure>
    <time_frame>Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</time_frame>
    <description>BILAG 2004 disease activity Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). Total BILAG score is sum of scores of 9 domains where A=12, B=8, C=1, D=0, and E=0. Total score ranges from 0 to 108 with a higher score indicating greater lupus activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</measure>
    <time_frame>Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</time_frame>
    <description>The Physician's Global Assessment of Disease Activity was recorded using the 100 millimeter horizontal Visual Analog Scale (VAS). Physician rated participant's disease activity on a scale ranged from 0-100 millimeter (mm), where 0 indicated no disease activity and 100 represented maximum disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52</measure>
    <time_frame>Baseline, Week 4, 8, 12, 16, 24, 32, 40 and 52</time_frame>
    <description>The 36-Item Short-Form Health Survey (SF-36) was a standardized survey evaluating 8 aspects of functional health and well-being. These eight subscales were summarized as relating to either physical health or mental health. Physical component summary (PCS) was based primarily on physical functioning, role-physical, bodily pain, and general health scales and mental component summary (MCS) encompasses vitality, social functioning, role-emotional, and mental health scales. Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0 - 100 (100 = highest level of mental functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100 = highest level of physical functioning).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52</measure>
    <time_frame>Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52</time_frame>
    <description>The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L profile defines health in terms of mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has five levels: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, and 5: extreme problems. Responses were used to generate a weighted summary index (EQ-5D index), which ranges from 0 (dead) to 1.00 (perfect health). A higher score indicates better health and positive changes from baseline indicate improvement of health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52</measure>
    <time_frame>Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52</time_frame>
    <description>The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L profile defines health in terms of mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has five levels: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, and 5: extreme problems. The responses were used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 was the worst health you can imagine and 100 was the best health you can imagine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52</measure>
    <time_frame>Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52</time_frame>
    <description>The Lupus QoL assessment is a 34 item questionnaire across 8 domains that is designed to find out how systemic lupus erythematosus (SLE) affects a participant's life. Domains include physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. Participants indicate their responses on a 5-point Likert response format, where 4=never, 3=occasionally, 2= a good bit of the time, 1=most of the time, and 0=worst of the time. Summary scores can be calculated for all 8 domains. A LupusQoL score for each domain was reported on a 0 to 100 scale, with greater values indicating better health related QoL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening</measure>
    <time_frame>Week 4, 8, 12, 16, 24, 32, 40, and 52</time_frame>
    <description>The PGIC is a self-rated scale that asks the participant to describe the change in activity limitations, symptoms, emotions, and overall quality of life (QoL) related to the participants painful condition on the following scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse). Number of participants in the PGIC categories of any improvement (that is PGIC scale score 1, 2 or 3), no change (that is PGIC scale score 4) and any worsening (that is PGIC scale score 5, 6 or 7) are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52</measure>
    <time_frame>Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52</time_frame>
    <description>The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assess self reported fatigue and its impact upon daily activities and function. It uses a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse possible score) to 52 (best score). A higher score reflected an improvement in the participant's health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Number of Participants With Change From Baseline in Prednisone Equivalent Corticosteroid (CS) Dose by &gt;=25% to a Dose of &lt;=7.5 Milligram Per Day (mg/Day), With no BILAG A or 2B Flare in Disease Activity at Week 52</measure>
    <time_frame>Baseline and Week 52</time_frame>
    <description>BILAG A or 2B flare is defined as at least one BILAG A grade or two BILAG B grade in any organ system due to items that are new or worse, compared to the BILAG evaluation at the previous visit, during the 52 week treatment period. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to systemic lupus erythematosus (SLE), divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</measure>
    <time_frame>Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</time_frame>
    <description>Change From Baseline in Prednisone-equivalent CS Daily Dose at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by &gt; 0 to 25%, &gt;25% to 50%, &gt;50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</measure>
    <time_frame>Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52</time_frame>
    <description>Number of Participants With Reduction From Baseline in Prednisone-equivalent Corticosteroid (CS) Daily Dose by &gt; 0 to 25%, &gt;25% to 50%, &gt;50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Cumulative Prednisone Equivalent Corticosteroid (CS) Dose at Week 52</measure>
    <time_frame>Week 52</time_frame>
    <description>Cumulative Prednisone-equivalent Corticosteroid (CS) Dose was calculated at Week 52.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52</measure>
    <time_frame>Week 52</time_frame>
    <description>SRI-4 response was defined as greater than or equal to (&gt;=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52</measure>
    <time_frame>Week 52</time_frame>
    <description>SRI-6 response was defined as &gt;= 6-point reduction in SLEDAI-2K total score, no new BILAG A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system :A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on SRI-4 at Week 52 in Serologically Active Subgroup</measure>
    <time_frame>Week 52</time_frame>
    <description>SRI-4 response was defined as greater than or equal to (&gt;=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale = from very well(0)-very poor(100).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBPC Period: Number of Participants With Lupus Low Disease Activity State (LLDAS) at Week 52</measure>
    <time_frame>Week 52</time_frame>
    <description>Lupus low disease activity state will be measured as: SLEDAI-2K &lt;= 4; No activity in any major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever); No new features of disease activity compared with the previous assessment; Prednisone-equivalent &lt;= 7.5 milligram per day; Unchanged background immunosuppressive therapy.</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">469</enrollment>
  <condition>Systemic Lupus Erythematosus</condition>
  <arm_group>
    <arm_group_label>Double-Blind Placebo-Controlled (DBPC) Period: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>DBPC Period: M2951 25 mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>DBPC Period: M2951 75 mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>DBPC Period: M2951 50 mg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Long-Term Extension (LTE) Period: Placebo/ M2951 50 mg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>LTE Period: M2951 25 mg QD/ M2951 50 mg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>LTE Period: M2951 75 mg QD/ M2951 50 mg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>LTE Period: M2951 50 mg BID/ M2951 50 mg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
    <arm_group_label>Double-Blind Placebo-Controlled (DBPC) Period: Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>M2951</intervention_name>
    <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
    <arm_group_label>DBPC Period: M2951 25 mg QD</arm_group_label>
    <other_name>Evobrutinib</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>M2951</intervention_name>
    <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
    <arm_group_label>DBPC Period: M2951 75 mg QD</arm_group_label>
    <other_name>Evobrutinib</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>M2951</intervention_name>
    <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
    <arm_group_label>DBPC Period: M2951 50 mg BID</arm_group_label>
    <other_name>Evobrutinib</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>M2951</intervention_name>
    <description>Participants who had received Placebo or M2951 (25 mg QD, 75 mg QD or 50 mg BID) during DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.</description>
    <arm_group_label>LTE Period: M2951 25 mg QD/ M2951 50 mg BID</arm_group_label>
    <arm_group_label>LTE Period: M2951 50 mg BID/ M2951 50 mg BID</arm_group_label>
    <arm_group_label>LTE Period: M2951 75 mg QD/ M2951 50 mg BID</arm_group_label>
    <arm_group_label>Long-Term Extension (LTE) Period: Placebo/ M2951 50 mg BID</arm_group_label>
    <other_name>Evobrutinib</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible male and female participants, aged 18 to 75 years&#xD;
&#xD;
          -  Must have diagnosis of SLE with either the Systemic Lupus International Collaborating&#xD;
             Clinics (SLICC) criteria for SLE, or at least four of the 11 American College of&#xD;
             Rheumatology (ACR) classification criteria for SLE, of at least six months duration&#xD;
             prior to Screening&#xD;
&#xD;
          -  SLEDAI-2K total score greater than or equal to (&gt;=) 6 (including clinical SLEDAI&#xD;
             greater than or equal to (&gt;=) 4) at Screening Visit&#xD;
&#xD;
          -  And be positive for anti-double-stranded Deoxyribonucleic Acid (DNA) and/or&#xD;
             anti-nuclear antibody (ANA greater than or equal to (&gt;=) 1:80) and/or anti-Smith&#xD;
             (anti-Sm) antibody at the time of Screening&#xD;
&#xD;
          -  Other protocol defined inclusion criteria could apply&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants are not eligible for this study if they have active, clinically&#xD;
             significant interstitial lung disease or pulmonary arterial hypertension&#xD;
&#xD;
          -  Proteinuria (urine protein to creatinine ratio [UPCR] &gt; 4 mg/mg)&#xD;
&#xD;
          -  Acutely worsened renal function&#xD;
&#xD;
          -  Central nervous system SLE&#xD;
&#xD;
          -  Or within two weeks prior to Screening or during Screening: use of oral&#xD;
             corticosteroids greater than (&gt;) 30 mg daily prednisone equivalent&#xD;
&#xD;
          -  Use of injectable corticosteroids, or change in dose of corticosteroids.&#xD;
&#xD;
          -  Other protocol defined exclusion criteria could apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Responsible</last_name>
    <role>Study Director</role>
    <affiliation>EMD Serono Research &amp; Development Institute, Inc., a business of Merck KGaA, Darmstadt, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pinnacle Research Group LLC</name>
      <address>
        <city>Anniston</city>
        <state>Alabama</state>
        <zip>36207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Arthritis &amp; Rheumatology Associates, P.C.</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Arthritis &amp; Rheumatology Associates, P.C.</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research Center, Inc.</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wallace Rheumatic Study Center</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medvin Clinical Research</name>
      <address>
        <city>Covina</city>
        <state>California</state>
        <zip>91722</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Permanent Medical Group</name>
      <address>
        <city>Fontana</city>
        <state>California</state>
        <zip>92335</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Global Research Management</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Bay Rheumatology Medical Group, Inc.</name>
      <address>
        <city>San Leandro</city>
        <state>California</state>
        <zip>94578</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inland Rheumatology Clinical Trials, Inc.</name>
      <address>
        <city>Upland</city>
        <state>California</state>
        <zip>91786</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nazanin Firooz, MD Inc.</name>
      <address>
        <city>West Hills</city>
        <state>California</state>
        <zip>91307</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Denver Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale School Of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of West Florida - Corporate</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Research Consultants</name>
      <address>
        <city>DeBary</city>
        <state>Florida</state>
        <zip>32713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Rheumatology, Immunology &amp; Arthritis</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hope Clinical Trials</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRIS Research and Development</name>
      <address>
        <city>Plantation</city>
        <state>Florida</state>
        <zip>33324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McIlwain Medical Group, PA</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridien Research, Inc.</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33634</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marietta Rheumatology Associates, PC</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Chicago Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LSU Health Sciences Center Gastroenterology</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AA MRC LLC Ahmed Arif Medical Research Center</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48439</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University in St. Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center PRIME</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUNY Upstate Medical Center</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medication Management, LLC</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny-Singer Research Institute</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innovative Clinical Research, LLC</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metroplex Clinical Research Center, LLC</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accurate Clinical Research, Inc.</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accurate Clinical Management - Brionez</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Research, LLC Webster Office</name>
      <address>
        <city>Pearland</city>
        <state>Texas</state>
        <zip>77584</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DM Clinical Research</name>
      <address>
        <city>Tomball</city>
        <state>Texas</state>
        <zip>77375</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSAEI HE &quot; First Moscow State Medical University n.a. I.M. Sechenov&quot; of the MoH of the RF</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Investigaciones Clinicas</name>
      <address>
        <city>Mar del Plata</city>
        <state>Buenos Aires</state>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Investigaciones Clinicas Quilmes</name>
      <address>
        <city>Quilmes</city>
        <state>Buenos Aires</state>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Medico Privado de Reumatologia</name>
      <address>
        <city>San Miguel de Tucuman</city>
        <state>Tucuman</state>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigaciones Clinicas Tucuman</name>
      <address>
        <city>San Miguel de Tucuman</city>
        <state>Tucuman</state>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Integral de Reumatologia</name>
      <address>
        <city>San Miguel de Tucumán</city>
        <state>Tucuman</state>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APRILLUS</name>
      <address>
        <city>Ciudad Autonoma Buenos aires</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada</name>
      <address>
        <city>Ciudad Autonoma Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Adventista Belgrano</name>
      <address>
        <city>Ciudad Autonoma Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Britanico de Buenos Aires</name>
      <address>
        <city>Ciudad Autonoma Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Agudos Dr. J. M. Ramos Mejia</name>
      <address>
        <city>Ciudad Autonoma Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorio Allende</name>
      <address>
        <city>Cordoba</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Reumatologia</name>
      <address>
        <city>Mendoza</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cordis S.A.</name>
      <address>
        <city>Salta</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Polivalente de Asistencia e Inv. Clinica CER</name>
      <address>
        <city>San Juan</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT &quot;Pulmed&quot; OOD</name>
      <address>
        <city>Plovdiv</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT - Ruse, AD</name>
      <address>
        <city>Ruse</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinski Zentar-1-Sevlievo EOOD</name>
      <address>
        <city>Sevlievo</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center &quot;Excelsior&quot;, OOD</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Comac Medical EOOD</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT &quot;SofiaMed&quot;, OOD</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT &quot;Sv. Ivan Rilski&quot;, EAD</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Corporacion de Beneficencia Osorno</name>
      <address>
        <city>Osorno</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Estudios Reumatologicos</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Medico Prosalud</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Interin</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Psicomedica Clinical and Research Group</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quantum Research Santiago</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Reumatologia y Ortopedia SAS</name>
      <address>
        <city>Barranquilla</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica de la Costa Ltda.</name>
      <address>
        <city>Barranquilla</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Instituto de Reumatologia Fernando Chalem</name>
      <address>
        <city>Bogota</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Simedics Ips Sas</name>
      <address>
        <city>Bogotá</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Servimed S.A.S.</name>
      <address>
        <city>Bucaramanga</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite Universitaetsmedizin Berlin - Campus Charite Mitte</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Humanitas Research Hospital</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Raffaele</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria- Università degli Studi della Campania &quot;Luigi Vanvitelli&quot;</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia</name>
      <address>
        <city>Reggio Emilia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Universitario Agostino Gemelli</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ehime University Hospital</name>
      <address>
        <city>Toon-shi</city>
        <state>Ehime-Ken</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tobata General Hospital</name>
      <address>
        <city>Kitakyushu-shi</city>
        <state>Fukuoka-Ken</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Occupational and Environmental Health Hospital</name>
      <address>
        <city>Kitakyushu-shi</city>
        <state>Fukuoka-Ken</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHO Asahikawa Medical Center</name>
      <address>
        <city>Asahikawa-shi</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanazawa University Hospital</name>
      <address>
        <city>Kanazawa-shi</city>
        <state>Ishikawa-Ken</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kagawa University Hospital</name>
      <address>
        <city>Kita-gun</city>
        <state>Kagawa-Ken</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eiraku Clinic</name>
      <address>
        <city>Kagoshima-shi</city>
        <state>Kagoshima-Ken</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Sendai-shi</city>
        <state>Miyagi-Ken</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seirei Hamamatsu General Hospital</name>
      <address>
        <city>Hamamatsu-shi</city>
        <state>Shizuoka-Ken</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dokkyo Medical University Hospital</name>
      <address>
        <city>Shimotsuga-gun</city>
        <state>Tochigi-Ken</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's International Hospital</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo-To</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Metropolitan Tama Medical Center</name>
      <address>
        <city>Fuchu-shi</city>
        <state>Tokyo-To</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nihon University Itabashi Hospital</name>
      <address>
        <city>Itabashi-ku</city>
        <state>Tokyo-To</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo-To</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tottori University Hospital</name>
      <address>
        <city>Yonago-shi</city>
        <state>Tottori-Ken</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ajou University Hospital</name>
      <address>
        <city>Suwon-si</city>
        <state>Gyeonggi-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dong-A University Hospital</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyungpook National University Hospital</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Konkuk University Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Yeouido St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pakar Sultanah Fatimah</name>
      <address>
        <city>Muar</city>
        <state>Johor</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Umum Sarawak</name>
      <address>
        <city>Kuching</city>
        <state>Sarawak</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Selayang</name>
      <address>
        <city>Batu Caves</city>
        <state>Selangor</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Medical University (IMU) Healthcare</name>
      <address>
        <city>Bukit Jalil</city>
        <state>Selangor</state>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Kuala Lumpur</name>
      <address>
        <city>Kuala Lumpur</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAP Research</name>
      <address>
        <city>Solferino-Phoenix</city>
        <country>Mauritius</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidad de Investigacion de las Enfermedades Reumaticas</name>
      <address>
        <city>Cuauhtemoc</city>
        <state>Distrito Federal</state>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinstile, S.A. de C.V.</name>
      <address>
        <city>Mexico</city>
        <state>Distrito Federal</state>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute S.C.</name>
      <address>
        <city>Tlalnepantla</city>
        <state>Estado De Mexico</state>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morales Vargas Centro de Investigacion, S.C.</name>
      <address>
        <city>Leon</city>
        <state>Guanajuato</state>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica de Investigacion en Reumatologia y Obesidad S.C.</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidad de Investigacion en Enfermedades Cronico Degenerativas SC</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accelerium S. de R.L. de C.V.</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo León</state>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Central Dr Ignacio Morones Prieto</name>
      <address>
        <city>San Luis Potosi</city>
        <state>San Luis Potos</state>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigacion y Biomedicina de Chihuahua, S.C.</name>
      <address>
        <city>Chihuahua</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hogar Clínica San Juan de Dios - Arequipa</name>
      <address>
        <city>Arequipa</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica El Golf</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Medica Cayetano Heredia</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica San Juan Bautista</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Vesalio</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GINOBS SA. Instituto de Ginecologia y Reproduccion</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nacional Cayetano Heredia</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICCV Research Instituto del Cerebro y la Columna Vertebral</name>
      <address>
        <city>Miraflores</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Angeles University Foundation Medical Center</name>
      <address>
        <city>Angeles City, Pampanga</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mary Mediatrix Medical Center</name>
      <address>
        <city>Batangas</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>De La Salle University Medical Center</name>
      <address>
        <city>Dasmariñas City, Cavite</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Davao Doctors Hospital</name>
      <address>
        <city>Davao City</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Philippines Medical Center</name>
      <address>
        <city>Davao City</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iloilo Doctors Hospital</name>
      <address>
        <city>Iloilo City</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Medical Center</name>
      <address>
        <city>Quezon City</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CERMED</name>
      <address>
        <city>Bialystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Uniwersytecki nr 2 im.dr J. Biziela</name>
      <address>
        <city>Bydgoszcz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska lek. Barbara Bazela</name>
      <address>
        <city>Elblag</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Plejady</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nzoz Atopia</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheuma Medicus Zaklad</name>
      <address>
        <city>Warsawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic &quot;Dr.I. Cantacuzino&quot;</name>
      <address>
        <city>Bucuresti</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic &quot;Sf. Maria&quot;</name>
      <address>
        <city>Bucuresti</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.C Mediab S.R.L</name>
      <address>
        <city>Tirgu Mures</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC &quot;Alliance Biomedical - Ural Group&quot;</name>
      <address>
        <city>Izhevsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TSBIH &quot;Krasnoyarsk Interdistrict Clinical Hospital of Emergency Medical Care n.a. N.S. Karpovich</name>
      <address>
        <city>Krasnoyarsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HMA - Hospital Maria Auxiliadora</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ultramed</name>
      <address>
        <city>Omsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC Medical Sanitary Unit#157</name>
      <address>
        <city>Saint-Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPb SBIH &quot;Clinical Rheumatological Hospital # 25&quot;</name>
      <address>
        <city>Saint-Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SIH &quot;Saratov City Clinical Hospital # 12&quot;</name>
      <address>
        <city>Saratov</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute of Emergency Medical Care</name>
      <address>
        <city>St. Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebbiolo LLC</name>
      <address>
        <city>Tomsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wits Clinical Research</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winelands Medical Research Centre</name>
      <address>
        <city>Stellenbosch</city>
        <state>Western Cape</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Naidoo, A - Netcare Umhlanga Hospital</name>
      <address>
        <city>Durban</city>
        <zip>4319</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Medical University Chung-Ho Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Bulgaria</country>
    <country>Chile</country>
    <country>Colombia</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Malaysia</country>
    <country>Mauritius</country>
    <country>Mexico</country>
    <country>Peru</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS200527-0018</url>
    <description>Trial Awareness and Transparency website</description>
  </link>
  <link>
    <url>https://medical.emdserono.com/en_US/home.html</url>
    <description>US Medical Information website, Medical Resources</description>
  </link>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <results_first_submitted>November 18, 2020</results_first_submitted>
  <results_first_submitted_qc>November 18, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 17, 2020</results_first_posted>
  <last_update_submitted>March 16, 2021</last_update_submitted>
  <last_update_submitted_qc>March 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Systemic Lupus Erythematosus</keyword>
  <keyword>M2951</keyword>
  <keyword>Placebo</keyword>
  <keyword>Dose response</keyword>
  <keyword>Oral Corticosteroids</keyword>
  <keyword>Safety</keyword>
  <keyword>Efficacy</keyword>
  <keyword>Autoimmune And Inflammatory Disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 22, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT02975336/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 11, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT02975336/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 1053 participants with Systemic Lupus Erythematosus (SLE) were screened. Out of which 469 participants were randomized in ratio of 1:1:1:1 to 1 of 4 treatment groups: Placebo; M2951 25mg QD, M2951 75 mg QD and M2951 50 mg BID. 283 out of 348 participants that completed Double-Blind Placebo-Controlled (DBPC) period, entered the Long-Term Extension (LTE) period of study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>DBPC Period: Placebo</title>
          <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
        </group>
        <group group_id="P2">
          <title>DBPC Period: M2951 25 mg QD</title>
          <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
        </group>
        <group group_id="P3">
          <title>DBPC Period: M2951 75 mg QD</title>
          <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
        </group>
        <group group_id="P4">
          <title>DBPC Period: M2951 50 mg BID</title>
          <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
        </group>
        <group group_id="P5">
          <title>LTE: Placebo/ M2951 50 mg BID</title>
          <description>Participants who received Placebo in DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.</description>
        </group>
        <group group_id="P6">
          <title>LTE Period: M2951 25 mg QD/ M2951 50 mg BID</title>
          <description>Participants who received 25 mg of M2951 orally QD in DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.</description>
        </group>
        <group group_id="P7">
          <title>LTE Period: M2951 75 mg QD/ M2951 50 mg BID</title>
          <description>Participants who received 75 mg of M2951 orally QD in DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.</description>
        </group>
        <group group_id="P8">
          <title>LTE: M2951 50 mg BID/ M2951 50 mg BID</title>
          <description>Participants who received 50 mg of M2951 orally BID in DBPC period continued to receive same dose of M2951 orally BID in LTE period for 104 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>DBPC (52 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="117"/>
                <participants group_id="P2" count="118"/>
                <participants group_id="P3" count="117"/>
                <participants group_id="P4" count="117"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="85"/>
                <participants group_id="P2" count="89"/>
                <participants group_id="P3" count="90"/>
                <participants group_id="P4" count="84"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="27"/>
                <participants group_id="P4" count="33"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="18"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Premature termination of the study</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>LTE (104 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="62"/>
                <participants group_id="P6" count="69"/>
                <participants group_id="P7" count="80"/>
                <participants group_id="P8" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="62"/>
                <participants group_id="P6" count="69"/>
                <participants group_id="P7" count="80"/>
                <participants group_id="P8" count="72"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="55"/>
                <participants group_id="P6" count="63"/>
                <participants group_id="P7" count="76"/>
                <participants group_id="P8" count="72"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>DBPC Period: Placebo</title>
          <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
        </group>
        <group group_id="B2">
          <title>DBPC Period: M2951 25 mg QD</title>
          <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
        </group>
        <group group_id="B3">
          <title>DBPC Period: M2951 75 mg QD</title>
          <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
        </group>
        <group group_id="B4">
          <title>DBPC Period: M2951 50 mg BID</title>
          <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="117"/>
            <count group_id="B2" value="118"/>
            <count group_id="B3" value="117"/>
            <count group_id="B4" value="117"/>
            <count group_id="B5" value="469"/>
          </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="40.2" spread="12.49"/>
                    <measurement group_id="B2" value="38.8" spread="12.45"/>
                    <measurement group_id="B3" value="41.5" spread="12.52"/>
                    <measurement group_id="B4" value="42.2" spread="11.78"/>
                    <measurement group_id="B5" value="40.7" spread="12.34"/>
                  </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="110"/>
                    <measurement group_id="B2" value="112"/>
                    <measurement group_id="B3" value="111"/>
                    <measurement group_id="B4" value="112"/>
                    <measurement group_id="B5" value="445"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="47"/>
                    <measurement group_id="B4" value="42"/>
                    <measurement group_id="B5" value="185"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="70"/>
                    <measurement group_id="B4" value="75"/>
                    <measurement group_id="B5" value="284"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="73"/>
                    <measurement group_id="B3" value="68"/>
                    <measurement group_id="B4" value="83"/>
                    <measurement group_id="B5" value="290"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52</title>
        <description>SRI-4 response was defined as greater than or equal to (&gt;=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE) divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).</description>
        <time_frame>Week 52</time_frame>
        <population>The modified Intent To Treat (mITT) analysis set included all randomized participants who had received at least one dose of Investigational Medicinal Product (IMP) [Evobrutinib or placebo] and have at least one Baseline and one post Baseline disease assessment (among the following: Systemic Lupus Erythematosus Disease Activity Index flare index [SFI], SLEDAI 2K, PGA, BILAG 2004, Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI]).</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52</title>
          <description>SRI-4 response was defined as greater than or equal to (&gt;=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE) divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).</description>
          <population>The modified Intent To Treat (mITT) analysis set included all randomized participants who had received at least one dose of Investigational Medicinal Product (IMP) [Evobrutinib or placebo] and have at least one Baseline and one post Baseline disease assessment (among the following: Systemic Lupus Erythematosus Disease Activity Index flare index [SFI], SLEDAI 2K, PGA, BILAG 2004, Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI]).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="115"/>
                <count group_id="O3" value="116"/>
                <count group_id="O4" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="64"/>
                    <measurement group_id="O3" value="60"/>
                    <measurement group_id="O4" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5462</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.91</ci_lower_limit>
            <ci_upper_limit>2.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5462</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>2.18</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5462</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.67</ci_lower_limit>
            <ci_upper_limit>1.93</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52</title>
        <description>SRI-6 response was defined as &gt;= 6-point reduction in SLEDAI-2K total score, no new BILAG A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system :A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).</description>
        <time_frame>Week 52</time_frame>
        <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;overall number of participants analyzed&quot; signifies those participants who achieved SLEDAI-2K total score &gt;= 10 at screening (High Disease Activity [HDA] participants).</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52</title>
          <description>SRI-6 response was defined as &gt;= 6-point reduction in SLEDAI-2K total score, no new BILAG A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system :A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).</description>
          <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;overall number of participants analyzed&quot; signifies those participants who achieved SLEDAI-2K total score &gt;= 10 at screening (High Disease Activity [HDA] participants).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="54"/>
                <count group_id="O3" value="65"/>
                <count group_id="O4" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="30"/>
                    <measurement group_id="O4" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5462</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>3.24</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5462</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.68</ci_lower_limit>
            <ci_upper_limit>2.97</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5462</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.59</ci_lower_limit>
            <ci_upper_limit>2.75</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)</title>
        <description>Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs: events between first dose of study drug that were absent before treatment/that worsened relative to pre-treatment state up to 56 weeks. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs and serious TEAEs were reported.</description>
        <time_frame>Baseline up to Week 56</time_frame>
        <population>The safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo).</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)</title>
          <description>Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs: events between first dose of study drug that were absent before treatment/that worsened relative to pre-treatment state up to 56 weeks. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs and serious TEAEs were reported.</description>
          <population>The safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
                <count group_id="O2" value="118"/>
                <count group_id="O3" value="117"/>
                <count group_id="O4" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="103"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)</title>
        <description>Severity of TEAEs were graded using NCI-CTCAE v4.03 toxicity grades, as follows: Grade 1= Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening and Grade 5 = Death. Number of participants with TEAEs by severity were reported.</description>
        <time_frame>Baseline up to Week 56</time_frame>
        <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo).</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)</title>
          <description>Severity of TEAEs were graded using NCI-CTCAE v4.03 toxicity grades, as follows: Grade 1= Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening and Grade 5 = Death. Number of participants with TEAEs by severity were reported.</description>
          <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
                <count group_id="O2" value="118"/>
                <count group_id="O3" value="117"/>
                <count group_id="O4" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76"/>
                    <measurement group_id="O2" value="80"/>
                    <measurement group_id="O3" value="79"/>
                    <measurement group_id="O4" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="77"/>
                    <measurement group_id="O3" value="72"/>
                    <measurement group_id="O4" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="24"/>
                    <measurement group_id="O4" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs</title>
        <description>Vital signs included body temperature, systolic and diastolic blood pressure, pulse rate, respiratory rate, weight and height. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in vital signs were reported.</description>
        <time_frame>Baseline up to Week 56</time_frame>
        <population>The safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo).</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs</title>
          <description>Vital signs included body temperature, systolic and diastolic blood pressure, pulse rate, respiratory rate, weight and height. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in vital signs were reported.</description>
          <population>The safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
                <count group_id="O2" value="118"/>
                <count group_id="O3" value="117"/>
                <count group_id="O4" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Findings</title>
        <description>12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. The corrected QT interval (QTcF) was calculated using Fridericia's formula. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semisupine position. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported.</description>
        <time_frame>Baseline up to Week 56</time_frame>
        <population>The safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo).</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Findings</title>
          <description>12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. The corrected QT interval (QTcF) was calculated using Fridericia's formula. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semisupine position. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported.</description>
          <population>The safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
                <count group_id="O2" value="118"/>
                <count group_id="O3" value="117"/>
                <count group_id="O4" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters</title>
        <description>Laboratory investigation included hematology, biochemistry, urinalysis and coagulation. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in laboratory parameters were reported.</description>
        <time_frame>Baseline up to Week 56</time_frame>
        <population>The safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo).</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters</title>
          <description>Laboratory investigation included hematology, biochemistry, urinalysis and coagulation. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in laboratory parameters were reported.</description>
          <population>The safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
                <count group_id="O2" value="118"/>
                <count group_id="O3" value="117"/>
                <count group_id="O4" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2</title>
        <description>Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 2.</description>
        <time_frame>Week 2</time_frame>
        <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2</title>
          <description>Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 2.</description>
          <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>gram per liter (g/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="116"/>
                <count group_id="O3" value="115"/>
                <count group_id="O4" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IgG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.56" spread="5.367"/>
                    <measurement group_id="O2" value="13.75" spread="4.652"/>
                    <measurement group_id="O3" value="14.37" spread="5.536"/>
                    <measurement group_id="O4" value="12.81" spread="3.847"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.62" spread="1.207"/>
                    <measurement group_id="O2" value="2.75" spread="1.374"/>
                    <measurement group_id="O3" value="2.78" spread="1.328"/>
                    <measurement group_id="O4" value="2.66" spread="1.137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.12" spread="0.662"/>
                    <measurement group_id="O2" value="1.22" spread="0.890"/>
                    <measurement group_id="O3" value="1.09" spread="0.697"/>
                    <measurement group_id="O4" value="1.18" spread="0.776"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4</title>
        <description>Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 4.</description>
        <time_frame>Week 4</time_frame>
        <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4</title>
          <description>Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 4.</description>
          <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>gram per liter (g/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="114"/>
                <count group_id="O3" value="114"/>
                <count group_id="O4" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IgG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.92" spread="5.497"/>
                    <measurement group_id="O2" value="13.60" spread="4.590"/>
                    <measurement group_id="O3" value="14.21" spread="4.828"/>
                    <measurement group_id="O4" value="12.73" spread="3.771"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.71" spread="1.284"/>
                    <measurement group_id="O2" value="2.73" spread="1.349"/>
                    <measurement group_id="O3" value="2.82" spread="1.293"/>
                    <measurement group_id="O4" value="2.64" spread="1.109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.12" spread="0.699"/>
                    <measurement group_id="O2" value="1.18" spread="0.824"/>
                    <measurement group_id="O3" value="1.06" spread="0.676"/>
                    <measurement group_id="O4" value="1.16" spread="0.745"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12</title>
        <description>Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 12.</description>
        <time_frame>Week 12</time_frame>
        <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12</title>
          <description>Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 12.</description>
          <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>gram per liter (g/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="106"/>
                <count group_id="O3" value="110"/>
                <count group_id="O4" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IgG:</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.91" spread="5.312"/>
                    <measurement group_id="O2" value="12.92" spread="4.332"/>
                    <measurement group_id="O3" value="13.64" spread="4.035"/>
                    <measurement group_id="O4" value="12.38" spread="3.520"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.72" spread="1.321"/>
                    <measurement group_id="O2" value="2.73" spread="1.340"/>
                    <measurement group_id="O3" value="2.88" spread="1.363"/>
                    <measurement group_id="O4" value="2.68" spread="1.021"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.11" spread="0.683"/>
                    <measurement group_id="O2" value="1.05" spread="0.700"/>
                    <measurement group_id="O3" value="0.95" spread="0.610"/>
                    <measurement group_id="O4" value="1.02" spread="0.695"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24</title>
        <description>Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 24.</description>
        <time_frame>Week 24</time_frame>
        <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24</title>
          <description>Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 24.</description>
          <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>gram per liter (g/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="97"/>
                <count group_id="O3" value="101"/>
                <count group_id="O4" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IgG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.01" spread="5.190"/>
                    <measurement group_id="O2" value="13.75" spread="4.783"/>
                    <measurement group_id="O3" value="13.79" spread="4.165"/>
                    <measurement group_id="O4" value="12.86" spread="3.725"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.79" spread="1.430"/>
                    <measurement group_id="O2" value="2.89" spread="1.460"/>
                    <measurement group_id="O3" value="2.98" spread="1.391"/>
                    <measurement group_id="O4" value="2.78" spread="1.091"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.07" spread="0.609"/>
                    <measurement group_id="O2" value="1.01" spread="0.686"/>
                    <measurement group_id="O3" value="0.89" spread="0.583"/>
                    <measurement group_id="O4" value="0.98" spread="0.656"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36</title>
        <description>Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 36.</description>
        <time_frame>Week 36</time_frame>
        <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36</title>
          <description>Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 36.</description>
          <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>gram per liter (g/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="91"/>
                <count group_id="O3" value="97"/>
                <count group_id="O4" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IgG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.81" spread="5.217"/>
                    <measurement group_id="O2" value="13.54" spread="4.242"/>
                    <measurement group_id="O3" value="13.67" spread="3.934"/>
                    <measurement group_id="O4" value="12.65" spread="3.480"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.72" spread="1.378"/>
                    <measurement group_id="O2" value="2.89" spread="1.418"/>
                    <measurement group_id="O3" value="3.01" spread="1.420"/>
                    <measurement group_id="O4" value="2.86" spread="1.073"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.06" spread="0.630"/>
                    <measurement group_id="O2" value="1.01" spread="0.669"/>
                    <measurement group_id="O3" value="0.85" spread="0.541"/>
                    <measurement group_id="O4" value="0.95" spread="0.656"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52</title>
        <description>Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 52</description>
        <time_frame>Week 52</time_frame>
        <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52</title>
          <description>Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 52</description>
          <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</population>
          <units>gram per liter (g/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IgG</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="83"/>
                    <count group_id="O3" value="85"/>
                    <count group_id="O4" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.21" spread="5.105"/>
                    <measurement group_id="O2" value="13.90" spread="4.087"/>
                    <measurement group_id="O3" value="14.32" spread="4.542"/>
                    <measurement group_id="O4" value="13.01" spread="3.723"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="83"/>
                    <count group_id="O3" value="85"/>
                    <count group_id="O4" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.82" spread="1.438"/>
                    <measurement group_id="O2" value="2.95" spread="1.596"/>
                    <measurement group_id="O3" value="3.17" spread="1.596"/>
                    <measurement group_id="O4" value="2.95" spread="1.159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgM</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="83"/>
                    <count group_id="O3" value="84"/>
                    <count group_id="O4" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.08" spread="0.624"/>
                    <measurement group_id="O2" value="0.94" spread="0.645"/>
                    <measurement group_id="O3" value="0.82" spread="0.487"/>
                    <measurement group_id="O4" value="0.96" spread="0.670"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56</title>
        <description>Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 56</description>
        <time_frame>Week 56</time_frame>
        <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56</title>
          <description>Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 56</description>
          <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>gram per liter (g/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="36"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IgG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.82" spread="5.504"/>
                    <measurement group_id="O2" value="14.25" spread="4.435"/>
                    <measurement group_id="O3" value="14.25" spread="4.626"/>
                    <measurement group_id="O4" value="13.12" spread="4.507"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.95" spread="1.549"/>
                    <measurement group_id="O2" value="3.01" spread="1.459"/>
                    <measurement group_id="O3" value="2.89" spread="1.655"/>
                    <measurement group_id="O4" value="3.03" spread="1.164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.11" spread="0.642"/>
                    <measurement group_id="O2" value="1.01" spread="0.601"/>
                    <measurement group_id="O3" value="0.95" spread="0.624"/>
                    <measurement group_id="O4" value="1.31" spread="0.869"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Mean Absolute Total B Cell Count at Week 4</title>
        <description>Mean total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.</description>
        <time_frame>Week 4</time_frame>
        <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Mean Absolute Total B Cell Count at Week 4</title>
          <description>Mean total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.</description>
          <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>Cells per microliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="99"/>
                <count group_id="O3" value="99"/>
                <count group_id="O4" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150" spread="126.9"/>
                    <measurement group_id="O2" value="236" spread="197.4"/>
                    <measurement group_id="O3" value="296" spread="243.8"/>
                    <measurement group_id="O4" value="229" spread="232.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Mean Absolute Total B Cell Count at Week 24</title>
        <description>Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.</description>
        <time_frame>Week 24</time_frame>
        <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Mean Absolute Total B Cell Count at Week 24</title>
          <description>Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.</description>
          <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>Cells per microliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="90"/>
                <count group_id="O3" value="87"/>
                <count group_id="O4" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="161" spread="125.8"/>
                    <measurement group_id="O2" value="184" spread="152.6"/>
                    <measurement group_id="O3" value="204" spread="158.3"/>
                    <measurement group_id="O4" value="151" spread="129.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Mean Absolute Total B Cell Count at Week 52</title>
        <description>Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.</description>
        <time_frame>Week 52</time_frame>
        <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Mean Absolute Total B Cell Count at Week 52</title>
          <description>Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.</description>
          <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>Cells per microliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="66"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169" spread="121.9"/>
                    <measurement group_id="O2" value="167" spread="168.7"/>
                    <measurement group_id="O3" value="180" spread="170.7"/>
                    <measurement group_id="O4" value="119" spread="84.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Mean Absolute Total B Cell Count at Week 56</title>
        <description>Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.</description>
        <time_frame>Week 56</time_frame>
        <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Mean Absolute Total B Cell Count at Week 56</title>
          <description>Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.</description>
          <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>Cells per microliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="27"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="164" spread="113.3"/>
                    <measurement group_id="O2" value="129" spread="100.0"/>
                    <measurement group_id="O3" value="156" spread="127.1"/>
                    <measurement group_id="O4" value="104" spread="71.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2</title>
        <description>Change from baseline in the serum levels of IgG, IgA, IgM were assessed.</description>
        <time_frame>Baseline and Week 2</time_frame>
        <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2</title>
          <description>Change from baseline in the serum levels of IgG, IgA, IgM were assessed.</description>
          <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>gram per liter (g/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="116"/>
                <count group_id="O3" value="115"/>
                <count group_id="O4" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IgG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.51" spread="1.726"/>
                    <measurement group_id="O2" value="-0.06" spread="1.361"/>
                    <measurement group_id="O3" value="-0.15" spread="1.772"/>
                    <measurement group_id="O4" value="-0.40" spread="1.025"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.11" spread="0.435"/>
                    <measurement group_id="O2" value="-0.04" spread="0.431"/>
                    <measurement group_id="O3" value="-0.01" spread="0.381"/>
                    <measurement group_id="O4" value="-0.03" spread="0.268"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.197"/>
                    <measurement group_id="O2" value="-0.05" spread="0.194"/>
                    <measurement group_id="O3" value="-0.04" spread="0.155"/>
                    <measurement group_id="O4" value="-0.07" spread="0.116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4</title>
        <description>Change from baseline in the serum levels of IgG, IgA, IgM were assessed.</description>
        <time_frame>Baseline and Week 4</time_frame>
        <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4</title>
          <description>Change from baseline in the serum levels of IgG, IgA, IgM were assessed.</description>
          <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>gram per liter (g/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="114"/>
                <count group_id="O3" value="114"/>
                <count group_id="O4" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IgG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.26" spread="1.760"/>
                    <measurement group_id="O2" value="-0.16" spread="1.463"/>
                    <measurement group_id="O3" value="-0.24" spread="1.657"/>
                    <measurement group_id="O4" value="-0.45" spread="1.150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.205"/>
                    <measurement group_id="O2" value="-0.04" spread="0.334"/>
                    <measurement group_id="O3" value="0.03" spread="0.447"/>
                    <measurement group_id="O4" value="-0.03" spread="0.301"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.195"/>
                    <measurement group_id="O2" value="-0.09" spread="0.175"/>
                    <measurement group_id="O3" value="-0.07" spread="0.192"/>
                    <measurement group_id="O4" value="-0.08" spread="0.159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12</title>
        <description>Change from baseline in the serum levels of IgG, IgA, IgM were assessed.</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12</title>
          <description>Change from baseline in the serum levels of IgG, IgA, IgM were assessed.</description>
          <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>gram per liter (g/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="106"/>
                <count group_id="O3" value="110"/>
                <count group_id="O4" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IgG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.36" spread="2.073"/>
                    <measurement group_id="O2" value="-0.62" spread="1.827"/>
                    <measurement group_id="O3" value="-0.72" spread="2.552"/>
                    <measurement group_id="O4" value="-0.93" spread="1.640"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.325"/>
                    <measurement group_id="O2" value="-0.02" spread="0.360"/>
                    <measurement group_id="O3" value="0.06" spread="0.518"/>
                    <measurement group_id="O4" value="-0.03" spread="0.340"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.194"/>
                    <measurement group_id="O2" value="-0.20" spread="0.301"/>
                    <measurement group_id="O3" value="-0.18" spread="0.277"/>
                    <measurement group_id="O4" value="-0.20" spread="0.250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24</title>
        <description>Change from baseline in the serum levels of IgG, IgA, IgM were assessed.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24</title>
          <description>Change from baseline in the serum levels of IgG, IgA, IgM were assessed.</description>
          <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>gram per liter (g/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="97"/>
                <count group_id="O3" value="101"/>
                <count group_id="O4" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IgG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.21" spread="2.318"/>
                    <measurement group_id="O2" value="0.11" spread="2.234"/>
                    <measurement group_id="O3" value="-0.46" spread="2.912"/>
                    <measurement group_id="O4" value="-0.57" spread="2.363"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.332"/>
                    <measurement group_id="O2" value="0.14" spread="0.390"/>
                    <measurement group_id="O3" value="0.19" spread="0.565"/>
                    <measurement group_id="O4" value="0.04" spread="0.563"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.264"/>
                    <measurement group_id="O2" value="-0.23" spread="0.369"/>
                    <measurement group_id="O3" value="-0.23" spread="0.321"/>
                    <measurement group_id="O4" value="-0.25" spread="0.346"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36</title>
        <description>Change from baseline in the serum levels of IgG, IgA, IgM were assessed.</description>
        <time_frame>Baseline and Week 36</time_frame>
        <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36</title>
          <description>Change from baseline in the serum levels of IgG, IgA, IgM were assessed.</description>
          <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>gram per liter (g/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="91"/>
                <count group_id="O3" value="97"/>
                <count group_id="O4" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IgG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.15" spread="2.130"/>
                    <measurement group_id="O2" value="0.02" spread="2.487"/>
                    <measurement group_id="O3" value="-0.43" spread="2.572"/>
                    <measurement group_id="O4" value="-0.69" spread="2.189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.361"/>
                    <measurement group_id="O2" value="0.22" spread="0.453"/>
                    <measurement group_id="O3" value="0.24" spread="0.583"/>
                    <measurement group_id="O4" value="0.08" spread="0.459"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.255"/>
                    <measurement group_id="O2" value="-0.25" spread="0.416"/>
                    <measurement group_id="O3" value="-0.25" spread="0.284"/>
                    <measurement group_id="O4" value="-0.28" spread="0.392"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52</title>
        <description>Change from baseline in the serum levels of IgG, IgA, IgM were assessed.</description>
        <time_frame>Baseline and Week 52</time_frame>
        <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52</title>
          <description>Change from baseline in the serum levels of IgG, IgA, IgM were assessed.</description>
          <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</population>
          <units>gram per liter (g/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="85"/>
                <count group_id="O4" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IgG</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="83"/>
                    <count group_id="O3" value="85"/>
                    <count group_id="O4" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.41" spread="2.898"/>
                    <measurement group_id="O2" value="0.29" spread="2.361"/>
                    <measurement group_id="O3" value="0.35" spread="2.688"/>
                    <measurement group_id="O4" value="-0.31" spread="2.344"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="83"/>
                    <count group_id="O3" value="85"/>
                    <count group_id="O4" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="0.420"/>
                    <measurement group_id="O2" value="0.32" spread="0.492"/>
                    <measurement group_id="O3" value="0.39" spread="0.767"/>
                    <measurement group_id="O4" value="0.18" spread="0.469"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgM</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="83"/>
                    <count group_id="O3" value="84"/>
                    <count group_id="O4" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.235"/>
                    <measurement group_id="O2" value="-0.25" spread="0.303"/>
                    <measurement group_id="O3" value="-0.21" spread="0.318"/>
                    <measurement group_id="O4" value="-0.33" spread="0.456"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56</title>
        <description>Change from baseline in the serum levels of IgG, IgA, IgM were assessed.</description>
        <time_frame>Baseline and Week 56</time_frame>
        <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56</title>
          <description>Change from baseline in the serum levels of IgG, IgA, IgM were assessed.</description>
          <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>gram per liter (g/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="36"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IgG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.74" spread="2.907"/>
                    <measurement group_id="O2" value="1.06" spread="2.607"/>
                    <measurement group_id="O3" value="0.74" spread="1.987"/>
                    <measurement group_id="O4" value="-0.40" spread="2.823"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.23" spread="0.468"/>
                    <measurement group_id="O2" value="0.48" spread="0.600"/>
                    <measurement group_id="O3" value="0.35" spread="0.488"/>
                    <measurement group_id="O4" value="0.26" spread="0.498"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IgM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.266"/>
                    <measurement group_id="O2" value="-0.15" spread="0.219"/>
                    <measurement group_id="O3" value="-0.11" spread="0.225"/>
                    <measurement group_id="O4" value="-0.21" spread="0.488"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Change From Baseline in Total B Cell Count at Week 4</title>
        <description>Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.</description>
        <time_frame>Baseline and Week 4</time_frame>
        <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Change From Baseline in Total B Cell Count at Week 4</title>
          <description>Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.</description>
          <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>Cells per microliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="88"/>
                <count group_id="O3" value="88"/>
                <count group_id="O4" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5" spread="93.7"/>
                    <measurement group_id="O2" value="65" spread="146.6"/>
                    <measurement group_id="O3" value="87" spread="146.2"/>
                    <measurement group_id="O4" value="67" spread="109.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Change From Baseline in Total B Cell Count at Week 24</title>
        <description>Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Change From Baseline in Total B Cell Count at Week 24</title>
          <description>Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.</description>
          <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>Cells per microliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="82"/>
                <count group_id="O3" value="73"/>
                <count group_id="O4" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" spread="98.1"/>
                    <measurement group_id="O2" value="5" spread="112.0"/>
                    <measurement group_id="O3" value="3" spread="103.2"/>
                    <measurement group_id="O4" value="-7" spread="134.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Change From Baseline in Total B Cell Count at Week 52</title>
        <description>Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.</description>
        <time_frame>Baseline and Week 52</time_frame>
        <population>The safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Change From Baseline in Total B Cell Count at Week 52</title>
          <description>Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.</description>
          <population>The safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>Cells per microliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="63"/>
                <count group_id="O4" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14" spread="103.0"/>
                    <measurement group_id="O2" value="-19" spread="133.3"/>
                    <measurement group_id="O3" value="-14" spread="147.5"/>
                    <measurement group_id="O4" value="-52" spread="215.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>DBPC Period: Change From Baseline in Total B Cell Count at Week 56</title>
        <description>Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.</description>
        <time_frame>Baseline and Week 56</time_frame>
        <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Change From Baseline in Total B Cell Count at Week 56</title>
          <description>Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.</description>
          <population>The Safety analysis set included all participants who received at least 1 dose of IMP (Evobrutinib or Placebo). Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>Cells per microliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" spread="96.2"/>
                    <measurement group_id="O2" value="-70" spread="138.2"/>
                    <measurement group_id="O3" value="-75" spread="192.1"/>
                    <measurement group_id="O4" value="-48" spread="85.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Time to First Severe British Isles Lupus Assessment Group (BILAG) A Flare</title>
        <description>BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). Total BILAG score is sum of scores of 9 domains where A=12, B=8, C=1, D=0, and E=0. Total score ranges from 0 to 108 with a higher score indicating greater lupus activity. Time to first severe flare, where a severe flare is defined as at least one BILAG A (Severe disease activity) score in any organ system due to items that are new or worse, compared to the BILAG evaluation at the previous visit, during the 52-Week Treatment. It was measured using Kaplan-Meier (KM) estimates.</description>
        <time_frame>Baseline up to Week 56</time_frame>
        <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Time to First Severe British Isles Lupus Assessment Group (BILAG) A Flare</title>
          <description>BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). Total BILAG score is sum of scores of 9 domains where A=12, B=8, C=1, D=0, and E=0. Total score ranges from 0 to 108 with a higher score indicating greater lupus activity. Time to first severe flare, where a severe flare is defined as at least one BILAG A (Severe disease activity) score in any organ system due to items that are new or worse, compared to the BILAG evaluation at the previous visit, during the 52-Week Treatment. It was measured using Kaplan-Meier (KM) estimates.</description>
          <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="29.0" upper_limit="337.0">NA indicated that median was not reached as the number of participants with events were too low in respect to number of participants censored to estimate the value.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="29.0" upper_limit="367.0">NA indicated that median was not reached as the number of participants with events were too low in respect to number of participants censored to estimate the value.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="29.0" upper_limit="225.0">NA indicated that median was not reached as the number of participants with events were too low in respect to number of participants censored to estimate the value.</measurement>
                    <measurement group_id="O4" value="NA" lower_limit="28.0" upper_limit="162.0">NA indicated that median was not reached as the number of participants with events were too low in respect to number of participants censored to estimate the value.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7034</p_value>
            <method>Cox proportional hazards model</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.57</ci_lower_limit>
            <ci_upper_limit>2.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5462</p_value>
            <method>Cox proportional hazards model</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.31</ci_lower_limit>
            <ci_upper_limit>1.52</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5462</p_value>
            <method>Cox proportional hazards model</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.42</ci_lower_limit>
            <ci_upper_limit>1.97</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52 in Serologically Active (SA) Subgroup</title>
        <description>SRI-4 response was defined as greater than or equal to (&gt;=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).</description>
        <time_frame>Week 52</time_frame>
        <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants with positive anti-double-stranded deoxyribonucleic acid (antidsDNA) and/or low complement levels at screening (Serologically active subgroup).</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52 in Serologically Active (SA) Subgroup</title>
          <description>SRI-4 response was defined as greater than or equal to (&gt;=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).</description>
          <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants with positive anti-double-stranded deoxyribonucleic acid (antidsDNA) and/or low complement levels at screening (Serologically active subgroup).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="29"/>
                    <measurement group_id="O4" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5462</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.74</ci_lower_limit>
            <ci_upper_limit>3.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5462</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.49</ci_lower_limit>
            <ci_upper_limit>2.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5462</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>2.81</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52 in Serologically Active Subgroup</title>
        <description>SRI-6 response was defined as &gt;= 6-point reduction in SLEDAI-2K total score, no new BILAG A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system :A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale = from 0(very well) to 100(very poor).</description>
        <time_frame>Week 52</time_frame>
        <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants with positive anti-double-stranded deoxyribonucleic acid (antidsDNA) and/or low complement levels at screening (Serologically active subgroup).</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52 in Serologically Active Subgroup</title>
          <description>SRI-6 response was defined as &gt;= 6-point reduction in SLEDAI-2K total score, no new BILAG A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system :A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale = from 0(very well) to 100(very poor).</description>
          <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants with positive anti-double-stranded deoxyribonucleic acid (antidsDNA) and/or low complement levels at screening (Serologically active subgroup).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="23"/>
                    <measurement group_id="O4" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2434</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>3.54</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2389</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>3.63</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1952</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>3.85</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Time to First British Isles Lupus Assessment Group (BILAG) A or 2B Moderate to Severe Flare</title>
        <description>BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). Total BILAG score is sum of scores of 9 domains where A=12, B=8, C=1, D=0, and E=0. Total score ranges from 0 to 108 with a higher score indicating greater lupus activity. A Moderate to Severe (BILAG A or 2B) flare is defined as at least one BILAG A (severe disease activity) grade or two BILAG B (moderate disease activity) grade in any organ system due to items that are new or worse, compared to the BILAG evaluation at the previous visit, during the 52 week treatment. It was measured using Kaplan-Meier (KM) estimates.</description>
        <time_frame>Baseline up to Week 56</time_frame>
        <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Time to First British Isles Lupus Assessment Group (BILAG) A or 2B Moderate to Severe Flare</title>
          <description>BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). Total BILAG score is sum of scores of 9 domains where A=12, B=8, C=1, D=0, and E=0. Total score ranges from 0 to 108 with a higher score indicating greater lupus activity. A Moderate to Severe (BILAG A or 2B) flare is defined as at least one BILAG A (severe disease activity) grade or two BILAG B (moderate disease activity) grade in any organ system due to items that are new or worse, compared to the BILAG evaluation at the previous visit, during the 52 week treatment. It was measured using Kaplan-Meier (KM) estimates.</description>
          <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="29.0" upper_limit="337.0">NA indicated that median was not reached as the number of participants with events were too low in respect to number of participants censored to estimate the value.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="27.0" upper_limit="365.0">NA indicated that median was not reached as the number of participants with events were too low in respect to number of participants censored to estimate the value.</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="29.0" upper_limit="308.0">NA indicated that median was not reached as the number of participants with events were too low in respect to number of participants censored to estimate the value.</measurement>
                    <measurement group_id="O4" value="NA" lower_limit="28.0" upper_limit="334.0">NA indicated that median was not reached as the number of participants with events were too low in respect to number of participants censored to estimate the value.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0987</p_value>
            <method>Cox proportional hazards model</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.59</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>2.89</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9201</p_value>
            <method>Cox proportional hazards model</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.51</ci_lower_limit>
            <ci_upper_limit>1.85</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5645</p_value>
            <method>Cox proportional hazards model</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>2.20</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Number of Participants With British Isles Lupus Assessment Group (BILAG) 2004 Flare-Free Status During the 52-Week Treatment Period</title>
        <description>A participant has a flare-free status if no flare has been reported during the 52-week treatment period. Participants who discontinued treatment prior to Week 52, without having a flare are counted as not being flare free at Week 52. A flare was defined as either 1 or more new BILAG-2004 A (severe disease activity) or 2 or more new BILAG-2004 B (moderate disease activity) items compared to the previous visit. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected.</description>
        <time_frame>up to Week 52</time_frame>
        <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Number of Participants With British Isles Lupus Assessment Group (BILAG) 2004 Flare-Free Status During the 52-Week Treatment Period</title>
          <description>A participant has a flare-free status if no flare has been reported during the 52-week treatment period. Participants who discontinued treatment prior to Week 52, without having a flare are counted as not being flare free at Week 52. A flare was defined as either 1 or more new BILAG-2004 A (severe disease activity) or 2 or more new BILAG-2004 B (moderate disease activity) items compared to the previous visit. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected.</description>
          <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="115"/>
                <count group_id="O3" value="116"/>
                <count group_id="O4" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="37"/>
                    <measurement group_id="O4" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3743</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.44</ci_lower_limit>
            <ci_upper_limit>1.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6445</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.50</ci_lower_limit>
            <ci_upper_limit>1.54</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2634</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.41</ci_lower_limit>
            <ci_upper_limit>1.28</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Annualized Flare Rate</title>
        <description>A flare was defined as either 1 or more new BILAG-2004 A (severe disease activity) or 2 or more new BILAG-2004 B (moderate disease activity) items compared to the previous visit. The occurrence of a new flare was checked for each available visit versus the previous available visit up to Week 52. If no new flares occurred, the number of flares was set to 0. Otherwise all flares were counted leading to the maximum number of flares of 13. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25 (1 year). The flare exposure time is the time up to Week 52 (date of BILAG-2004 assessment at Week 52) or up to the date of last available BILAG 2004 assessment.</description>
        <time_frame>Baseline up to Week 52</time_frame>
        <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Annualized Flare Rate</title>
          <description>A flare was defined as either 1 or more new BILAG-2004 A (severe disease activity) or 2 or more new BILAG-2004 B (moderate disease activity) items compared to the previous visit. The occurrence of a new flare was checked for each available visit versus the previous available visit up to Week 52. If no new flares occurred, the number of flares was set to 0. Otherwise all flares were counted leading to the maximum number of flares of 13. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25 (1 year). The flare exposure time is the time up to Week 52 (date of BILAG-2004 assessment at Week 52) or up to the date of last available BILAG 2004 assessment.</description>
          <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI.</population>
          <units>Annualized flare rate ratio</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="115"/>
                <count group_id="O3" value="116"/>
                <count group_id="O4" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.15" lower_limit="0.06" upper_limit="0.39"/>
                    <measurement group_id="O2" value="0.23" lower_limit="0.09" upper_limit="0.59"/>
                    <measurement group_id="O3" value="0.13" lower_limit="0.05" upper_limit="0.33"/>
                    <measurement group_id="O4" value="0.19" lower_limit="0.07" upper_limit="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2989</p_value>
            <p_value_desc>Nominal p-value</p_value_desc>
            <method>Negative binomial regression</method>
            <param_type>Rate Ratio</param_type>
            <param_value>1.59</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>3.81</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7325</p_value>
            <p_value_desc>Nominal p-value</p_value_desc>
            <method>Negative binomial regression</method>
            <param_type>Rate Ratio</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.33</ci_lower_limit>
            <ci_upper_limit>2.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5910</p_value>
            <p_value_desc>Nominal p-value</p_value_desc>
            <method>Negative binomial regression</method>
            <param_type>Rate Ratio</param_type>
            <param_value>1.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.51</ci_lower_limit>
            <ci_upper_limit>3.22</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (&lt;= ) 2 at Week 52</title>
        <description>Low disease activity is defined as SLEDAI-2K score &lt;=2. SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 30 days. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).</description>
        <time_frame>Week 52</time_frame>
        <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (&lt;= ) 2 at Week 52</title>
          <description>Low disease activity is defined as SLEDAI-2K score &lt;=2. SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 30 days. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).</description>
          <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="115"/>
                <count group_id="O3" value="116"/>
                <count group_id="O4" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26" lower_limit="15.5" upper_limit="31.6"/>
                    <measurement group_id="O2" value="32" lower_limit="19.9" upper_limit="37.0"/>
                    <measurement group_id="O3" value="39" lower_limit="25.1" upper_limit="43.0"/>
                    <measurement group_id="O4" value="28" lower_limit="17.0" upper_limit="33.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3635</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>2.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0329</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.06</ci_lower_limit>
            <ci_upper_limit>3.56</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7619</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.59</ci_lower_limit>
            <ci_upper_limit>2.07</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Clinical Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (&lt;= ) 2 at Week 52</title>
        <description>Low disease activity is defined as SLEDAI-2K score &lt;=2. SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 30 days. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms). Clinical SLEDAI-2K score is equal to the SLEDAI-2K score from electronic case report form (eCRF) excluding the components 'Increased Deoxyribonucleic acid (DNA) Binding' and 'Low Complement'.</description>
        <time_frame>Week 52</time_frame>
        <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Clinical Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (&lt;= ) 2 at Week 52</title>
          <description>Low disease activity is defined as SLEDAI-2K score &lt;=2. SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 30 days. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms). Clinical SLEDAI-2K score is equal to the SLEDAI-2K score from electronic case report form (eCRF) excluding the components 'Increased Deoxyribonucleic acid (DNA) Binding' and 'Low Complement'.</description>
          <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="115"/>
                <count group_id="O3" value="116"/>
                <count group_id="O4" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42" lower_limit="28.0" upper_limit="46.4"/>
                    <measurement group_id="O2" value="50" lower_limit="34.3" upper_limit="53.0"/>
                    <measurement group_id="O3" value="52" lower_limit="35.6" upper_limit="54.3"/>
                    <measurement group_id="O4" value="41" lower_limit="27.2" upper_limit="45.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2642</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>2.35</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1489</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>2.57</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9285</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.56</ci_lower_limit>
            <ci_upper_limit>1.70</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</title>
        <description>SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 30 days. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).</description>
        <time_frame>Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</time_frame>
        <population>The mITT analysis set included all randomized participants who had received at least 1 dose of IMP (Evobrutinib or placebo) and have at least 1 Baseline and 1 post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</title>
          <description>SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 30 days. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).</description>
          <population>The mITT analysis set included all randomized participants who had received at least 1 dose of IMP (Evobrutinib or placebo) and have at least 1 Baseline and 1 post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</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="111"/>
                <count group_id="O2" value="115"/>
                <count group_id="O3" value="115"/>
                <count group_id="O4" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="115"/>
                    <count group_id="O3" value="115"/>
                    <count group_id="O4" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1" spread="1.9"/>
                    <measurement group_id="O2" value="-1" spread="2.1"/>
                    <measurement group_id="O3" value="0" spread="1.9"/>
                    <measurement group_id="O4" value="-1" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="111"/>
                    <count group_id="O3" value="112"/>
                    <count group_id="O4" value="109"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2" spread="3.1"/>
                    <measurement group_id="O2" value="-2" spread="3.2"/>
                    <measurement group_id="O3" value="-2" spread="3.0"/>
                    <measurement group_id="O4" value="-2" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="106"/>
                    <count group_id="O3" value="109"/>
                    <count group_id="O4" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3" spread="3.8"/>
                    <measurement group_id="O2" value="-3" spread="3.3"/>
                    <measurement group_id="O3" value="-3" spread="3.2"/>
                    <measurement group_id="O4" value="-3" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="107"/>
                    <count group_id="O4" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4" spread="3.7"/>
                    <measurement group_id="O2" value="-3" spread="3.4"/>
                    <measurement group_id="O3" value="-3" spread="3.4"/>
                    <measurement group_id="O4" value="-3" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="99"/>
                    <count group_id="O3" value="103"/>
                    <count group_id="O4" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4" spread="4.1"/>
                    <measurement group_id="O2" value="-4" spread="3.8"/>
                    <measurement group_id="O3" value="-4" spread="3.4"/>
                    <measurement group_id="O4" value="-4" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4" spread="4.0"/>
                    <measurement group_id="O2" value="-4" spread="3.7"/>
                    <measurement group_id="O3" value="-4" spread="3.6"/>
                    <measurement group_id="O4" value="-3" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="99"/>
                    <count group_id="O4" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4" spread="3.9"/>
                    <measurement group_id="O2" value="-4" spread="3.6"/>
                    <measurement group_id="O3" value="-4" spread="3.5"/>
                    <measurement group_id="O4" value="-4" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="97"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4" spread="4.0"/>
                    <measurement group_id="O2" value="-4" spread="3.5"/>
                    <measurement group_id="O3" value="-4" spread="3.7"/>
                    <measurement group_id="O4" value="-4" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="95"/>
                    <count group_id="O4" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4" spread="4.3"/>
                    <measurement group_id="O2" value="-5" spread="3.5"/>
                    <measurement group_id="O3" value="-5" spread="3.6"/>
                    <measurement group_id="O4" value="-4" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="95"/>
                    <count group_id="O4" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5" spread="4.1"/>
                    <measurement group_id="O2" value="-5" spread="3.6"/>
                    <measurement group_id="O3" value="-5" spread="3.8"/>
                    <measurement group_id="O4" value="-4" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4" spread="4.0"/>
                    <measurement group_id="O2" value="-5" spread="3.7"/>
                    <measurement group_id="O3" value="-5" spread="3.9"/>
                    <measurement group_id="O4" value="-4" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4" spread="4.1"/>
                    <measurement group_id="O2" value="-5" spread="3.7"/>
                    <measurement group_id="O3" value="-5" spread="3.8"/>
                    <measurement group_id="O4" value="-5" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5" spread="4.0"/>
                    <measurement group_id="O2" value="-5" spread="3.7"/>
                    <measurement group_id="O3" value="-5" spread="3.7"/>
                    <measurement group_id="O4" value="-5" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</title>
        <description>CLASI is an validated measurement instrument for lupus erythematosus developed for use in clinical studies that consists of separate scores for the activity of the disease (CLASI-A). The CLASI activity score is calculated on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI activity score ranges from 0-70, with higher scores indicating more severe skin disease. Severity categories based on the CLASI activity score are as follows: mild (0-9), moderate (10-20), and severe (21-70).</description>
        <time_frame>Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</time_frame>
        <population>The mITT analysis set included all randomized participants who had received at least 1 dose of IMP (Evobrutinib or placebo) and have at least 1 Baseline and 1 post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</title>
          <description>CLASI is an validated measurement instrument for lupus erythematosus developed for use in clinical studies that consists of separate scores for the activity of the disease (CLASI-A). The CLASI activity score is calculated on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI activity score ranges from 0-70, with higher scores indicating more severe skin disease. Severity categories based on the CLASI activity score are as follows: mild (0-9), moderate (10-20), and severe (21-70).</description>
          <population>The mITT analysis set included all randomized participants who had received at least 1 dose of IMP (Evobrutinib or placebo) and have at least 1 Baseline and 1 post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</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="111"/>
                <count group_id="O2" value="113"/>
                <count group_id="O3" value="115"/>
                <count group_id="O4" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="113"/>
                    <count group_id="O3" value="113"/>
                    <count group_id="O4" value="109"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1" spread="1.9"/>
                    <measurement group_id="O2" value="-1" spread="1.6"/>
                    <measurement group_id="O3" value="0" spread="1.6"/>
                    <measurement group_id="O4" value="0" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="113"/>
                    <count group_id="O3" value="115"/>
                    <count group_id="O4" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1" spread="1.9"/>
                    <measurement group_id="O2" value="-1" spread="3.5"/>
                    <measurement group_id="O3" value="-1" spread="2.4"/>
                    <measurement group_id="O4" value="-1" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="109"/>
                    <count group_id="O3" value="110"/>
                    <count group_id="O4" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2" spread="2.8"/>
                    <measurement group_id="O2" value="-1" spread="4.2"/>
                    <measurement group_id="O3" value="-1" spread="2.3"/>
                    <measurement group_id="O4" value="-1" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="104"/>
                    <count group_id="O3" value="107"/>
                    <count group_id="O4" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2" spread="2.8"/>
                    <measurement group_id="O2" value="-2" spread="3.3"/>
                    <measurement group_id="O3" value="-2" spread="3.2"/>
                    <measurement group_id="O4" value="-2" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="107"/>
                    <count group_id="O4" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2" spread="3.1"/>
                    <measurement group_id="O2" value="-2" spread="3.9"/>
                    <measurement group_id="O3" value="-2" spread="3.3"/>
                    <measurement group_id="O4" value="-2" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="96"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3" spread="3.6"/>
                    <measurement group_id="O2" value="-3" spread="4.4"/>
                    <measurement group_id="O3" value="-3" spread="3.4"/>
                    <measurement group_id="O4" value="-2" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="100"/>
                    <count group_id="O4" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3" spread="3.5"/>
                    <measurement group_id="O2" value="-3" spread="4.7"/>
                    <measurement group_id="O3" value="-3" spread="3.6"/>
                    <measurement group_id="O4" value="-2" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="96"/>
                    <count group_id="O4" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3" spread="3.7"/>
                    <measurement group_id="O2" value="-3" spread="4.6"/>
                    <measurement group_id="O3" value="-3" spread="3.4"/>
                    <measurement group_id="O4" value="-2" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="96"/>
                    <count group_id="O4" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3" spread="3.5"/>
                    <measurement group_id="O2" value="-3" spread="4.4"/>
                    <measurement group_id="O3" value="-3" spread="3.6"/>
                    <measurement group_id="O4" value="-3" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="95"/>
                    <count group_id="O4" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3" spread="3.5"/>
                    <measurement group_id="O2" value="-3" spread="4.6"/>
                    <measurement group_id="O3" value="-3" spread="3.4"/>
                    <measurement group_id="O4" value="-3" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3" spread="3.0"/>
                    <measurement group_id="O2" value="-3" spread="4.6"/>
                    <measurement group_id="O3" value="-3" spread="3.6"/>
                    <measurement group_id="O4" value="-3" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3" spread="3.2"/>
                    <measurement group_id="O2" value="-3" spread="4.5"/>
                    <measurement group_id="O3" value="-3" spread="3.7"/>
                    <measurement group_id="O4" value="-3" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3" spread="3.2"/>
                    <measurement group_id="O2" value="-3" spread="4.7"/>
                    <measurement group_id="O3" value="-3" spread="3.7"/>
                    <measurement group_id="O4" value="-3" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="89"/>
                    <count group_id="O4" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3" spread="3.6"/>
                    <measurement group_id="O2" value="-4" spread="4.8"/>
                    <measurement group_id="O3" value="-3" spread="3.7"/>
                    <measurement group_id="O4" value="-3" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Number of Participants With Response Based on BILAG-Based Composite Lupus Assessment (BICLA) at Week 52</title>
        <description>BICLA response defined as participants meeting following criteria: [1] At least one gradation of improvement in baseline BILAG scores in all body systems with moderate or severe disease activity at entry (example: all A (severe disease) scores falling to B (moderate), C (mild), or D (no activity) and all B scores falling to C or D; [2] No new BILAG A or more than one new BILAG B scores; [3] No worsening of total SLEDAI-2K score from baseline; [4] No significant deterioration (=&lt;10%) in physician's global assessment and [5] No treatment failure (initiation of non-protocol treatment).</description>
        <time_frame>Week 52</time_frame>
        <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who have at least 1 BILAG A or 2 BILAG B grades at Baseline (BICLA Subpopulation).</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Number of Participants With Response Based on BILAG-Based Composite Lupus Assessment (BICLA) at Week 52</title>
          <description>BICLA response defined as participants meeting following criteria: [1] At least one gradation of improvement in baseline BILAG scores in all body systems with moderate or severe disease activity at entry (example: all A (severe disease) scores falling to B (moderate), C (mild), or D (no activity) and all B scores falling to C or D; [2] No new BILAG A or more than one new BILAG B scores; [3] No worsening of total SLEDAI-2K score from baseline; [4] No significant deterioration (=&lt;10%) in physician's global assessment and [5] No treatment failure (initiation of non-protocol treatment).</description>
          <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who have at least 1 BILAG A or 2 BILAG B grades at Baseline (BICLA Subpopulation).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="33"/>
                    <measurement group_id="O4" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9061</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.49</ci_lower_limit>
            <ci_upper_limit>1.88</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6053</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.61</ci_lower_limit>
            <ci_upper_limit>2.31</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5200</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.40</ci_lower_limit>
            <ci_upper_limit>1.59</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</title>
        <description>BILAG 2004 disease activity Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). Total BILAG score is sum of scores of 9 domains where A=12, B=8, C=1, D=0, and E=0. Total score ranges from 0 to 108 with a higher score indicating greater lupus activity.</description>
        <time_frame>Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</time_frame>
        <population>The mITT analysis set included all randomized participants who had received at least 1 dose of IMP (Evobrutinib or placebo) and have at least 1 Baseline and 1 post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</title>
          <description>BILAG 2004 disease activity Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). Total BILAG score is sum of scores of 9 domains where A=12, B=8, C=1, D=0, and E=0. Total score ranges from 0 to 108 with a higher score indicating greater lupus activity.</description>
          <population>The mITT analysis set included all randomized participants who had received at least 1 dose of IMP (Evobrutinib or placebo) and have at least 1 Baseline and 1 post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</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="110"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="109"/>
                <count group_id="O4" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="108"/>
                    <count group_id="O4" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4" spread="5.8"/>
                    <measurement group_id="O2" value="-4" spread="6.1"/>
                    <measurement group_id="O3" value="-3" spread="6.3"/>
                    <measurement group_id="O4" value="-4" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="111"/>
                    <count group_id="O3" value="109"/>
                    <count group_id="O4" value="109"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6" spread="6.0"/>
                    <measurement group_id="O2" value="-5" spread="7.0"/>
                    <measurement group_id="O3" value="-6" spread="6.3"/>
                    <measurement group_id="O4" value="-6" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="109"/>
                    <count group_id="O2" value="106"/>
                    <count group_id="O3" value="107"/>
                    <count group_id="O4" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7" spread="6.7"/>
                    <measurement group_id="O2" value="-7" spread="6.8"/>
                    <measurement group_id="O3" value="-6" spread="7.0"/>
                    <measurement group_id="O4" value="-6" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="105"/>
                    <count group_id="O4" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7" spread="6.9"/>
                    <measurement group_id="O2" value="-7" spread="7.6"/>
                    <measurement group_id="O3" value="-6" spread="6.8"/>
                    <measurement group_id="O4" value="-6" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="99"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7" spread="6.8"/>
                    <measurement group_id="O2" value="-7" spread="7.3"/>
                    <measurement group_id="O3" value="-7" spread="7.6"/>
                    <measurement group_id="O4" value="-6" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="100"/>
                    <count group_id="O4" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8" spread="6.9"/>
                    <measurement group_id="O2" value="-7" spread="6.5"/>
                    <measurement group_id="O3" value="-8" spread="7.7"/>
                    <measurement group_id="O4" value="-6" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="98"/>
                    <count group_id="O4" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8" spread="6.7"/>
                    <measurement group_id="O2" value="-8" spread="6.9"/>
                    <measurement group_id="O3" value="-8" spread="7.4"/>
                    <measurement group_id="O4" value="-7" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="96"/>
                    <count group_id="O4" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9" spread="6.7"/>
                    <measurement group_id="O2" value="-8" spread="7.3"/>
                    <measurement group_id="O3" value="-8" spread="7.9"/>
                    <measurement group_id="O4" value="-7" spread="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="95"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8" spread="7.1"/>
                    <measurement group_id="O2" value="-8" spread="7.2"/>
                    <measurement group_id="O3" value="-8" spread="7.4"/>
                    <measurement group_id="O4" value="-7" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="95"/>
                    <count group_id="O4" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9" spread="6.8"/>
                    <measurement group_id="O2" value="-8" spread="6.7"/>
                    <measurement group_id="O3" value="-9" spread="7.7"/>
                    <measurement group_id="O4" value="-7" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9" spread="7.2"/>
                    <measurement group_id="O2" value="-9" spread="7.2"/>
                    <measurement group_id="O3" value="-9" spread="7.9"/>
                    <measurement group_id="O4" value="-7" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8" spread="7.1"/>
                    <measurement group_id="O2" value="-8" spread="7.2"/>
                    <measurement group_id="O3" value="-9" spread="7.6"/>
                    <measurement group_id="O4" value="-7" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8" spread="7.0"/>
                    <measurement group_id="O2" value="-9" spread="6.8"/>
                    <measurement group_id="O3" value="-9" spread="7.8"/>
                    <measurement group_id="O4" value="-7" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</title>
        <description>The Physician's Global Assessment of Disease Activity was recorded using the 100 millimeter horizontal Visual Analog Scale (VAS). Physician rated participant's disease activity on a scale ranged from 0-100 millimeter (mm), where 0 indicated no disease activity and 100 represented maximum disease activity.</description>
        <time_frame>Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</time_frame>
        <population>The mITT analysis set included all randomized participants who had received at least 1 dose of IMP (Evobrutinib or placebo) and have at least 1 Baseline and 1 post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</title>
          <description>The Physician's Global Assessment of Disease Activity was recorded using the 100 millimeter horizontal Visual Analog Scale (VAS). Physician rated participant's disease activity on a scale ranged from 0-100 millimeter (mm), where 0 indicated no disease activity and 100 represented maximum disease activity.</description>
          <population>The mITT analysis set included all randomized participants who had received at least 1 dose of IMP (Evobrutinib or placebo) and have at least 1 Baseline and 1 post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</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="111"/>
                <count group_id="O2" value="115"/>
                <count group_id="O3" value="115"/>
                <count group_id="O4" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="115"/>
                    <count group_id="O3" value="115"/>
                    <count group_id="O4" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8" spread="11.7"/>
                    <measurement group_id="O2" value="-8" spread="14.1"/>
                    <measurement group_id="O3" value="-9" spread="13.4"/>
                    <measurement group_id="O4" value="-9" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="109"/>
                    <count group_id="O3" value="111"/>
                    <count group_id="O4" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13" spread="16.2"/>
                    <measurement group_id="O2" value="-14" spread="16.5"/>
                    <measurement group_id="O3" value="-13" spread="15.5"/>
                    <measurement group_id="O4" value="-14" spread="15.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="104"/>
                    <count group_id="O3" value="107"/>
                    <count group_id="O4" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18" spread="17.4"/>
                    <measurement group_id="O2" value="-18" spread="18.8"/>
                    <measurement group_id="O3" value="-19" spread="18.3"/>
                    <measurement group_id="O4" value="-18" spread="16.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="105"/>
                    <count group_id="O4" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21" spread="17.6"/>
                    <measurement group_id="O2" value="-20" spread="19.7"/>
                    <measurement group_id="O3" value="-21" spread="18.7"/>
                    <measurement group_id="O4" value="-19" spread="18.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="96"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23" spread="19.2"/>
                    <measurement group_id="O2" value="-21" spread="19.5"/>
                    <measurement group_id="O3" value="-24" spread="17.9"/>
                    <measurement group_id="O4" value="-20" spread="18.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="100"/>
                    <count group_id="O4" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24" spread="17.8"/>
                    <measurement group_id="O2" value="-24" spread="20.0"/>
                    <measurement group_id="O3" value="-25" spread="19.2"/>
                    <measurement group_id="O4" value="-21" spread="18.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="96"/>
                    <count group_id="O4" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26" spread="17.6"/>
                    <measurement group_id="O2" value="-26" spread="20.3"/>
                    <measurement group_id="O3" value="-26" spread="18.6"/>
                    <measurement group_id="O4" value="-24" spread="17.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="96"/>
                    <count group_id="O4" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26" spread="17.8"/>
                    <measurement group_id="O2" value="-26" spread="20.8"/>
                    <measurement group_id="O3" value="-26" spread="19.0"/>
                    <measurement group_id="O4" value="-26" spread="17.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="95"/>
                    <count group_id="O4" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26" spread="17.9"/>
                    <measurement group_id="O2" value="-26" spread="20.9"/>
                    <measurement group_id="O3" value="-29" spread="18.3"/>
                    <measurement group_id="O4" value="-26" spread="18.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27" spread="16.9"/>
                    <measurement group_id="O2" value="-27" spread="19.1"/>
                    <measurement group_id="O3" value="-30" spread="19.7"/>
                    <measurement group_id="O4" value="-25" spread="18.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28" spread="16.6"/>
                    <measurement group_id="O2" value="-28" spread="20.1"/>
                    <measurement group_id="O3" value="-30" spread="20.7"/>
                    <measurement group_id="O4" value="-26" spread="16.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29" spread="16.5"/>
                    <measurement group_id="O2" value="-29" spread="19.5"/>
                    <measurement group_id="O3" value="-32" spread="18.8"/>
                    <measurement group_id="O4" value="-28" spread="18.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="89"/>
                    <count group_id="O4" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29" spread="16.2"/>
                    <measurement group_id="O2" value="-31" spread="20.7"/>
                    <measurement group_id="O3" value="-33" spread="19.2"/>
                    <measurement group_id="O4" value="-27" spread="18.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52</title>
        <description>The 36-Item Short-Form Health Survey (SF-36) was a standardized survey evaluating 8 aspects of functional health and well-being. These eight subscales were summarized as relating to either physical health or mental health. Physical component summary (PCS) was based primarily on physical functioning, role-physical, bodily pain, and general health scales and mental component summary (MCS) encompasses vitality, social functioning, role-emotional, and mental health scales. Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0 - 100 (100 = highest level of mental functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100 = highest level of physical functioning).</description>
        <time_frame>Baseline, Week 4, 8, 12, 16, 24, 32, 40 and 52</time_frame>
        <population>Quality of Life analysis set included all randomized participants who had received at least 1 dose of IMP (Evobrutinib or placebo) and had at least 1 Baseline and 1 post baseline QoL assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52</title>
          <description>The 36-Item Short-Form Health Survey (SF-36) was a standardized survey evaluating 8 aspects of functional health and well-being. These eight subscales were summarized as relating to either physical health or mental health. Physical component summary (PCS) was based primarily on physical functioning, role-physical, bodily pain, and general health scales and mental component summary (MCS) encompasses vitality, social functioning, role-emotional, and mental health scales. Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0 - 100 (100 = highest level of mental functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100 = highest level of physical functioning).</description>
          <population>Quality of Life analysis set included all randomized participants who had received at least 1 dose of IMP (Evobrutinib or placebo) and had at least 1 Baseline and 1 post baseline QoL assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</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="110"/>
                <count group_id="O2" value="114"/>
                <count group_id="O3" value="112"/>
                <count group_id="O4" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Component Summary Score at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="114"/>
                    <count group_id="O3" value="112"/>
                    <count group_id="O4" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="5.42"/>
                    <measurement group_id="O2" value="2.5" spread="7.40"/>
                    <measurement group_id="O3" value="3.5" spread="6.01"/>
                    <measurement group_id="O4" value="2.2" spread="5.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Component Summary Score at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="109"/>
                    <count group_id="O4" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="6.35"/>
                    <measurement group_id="O2" value="3.5" spread="7.69"/>
                    <measurement group_id="O3" value="3.0" spread="6.61"/>
                    <measurement group_id="O4" value="2.2" spread="6.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Component Summary Score at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="103"/>
                    <count group_id="O4" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="6.44"/>
                    <measurement group_id="O2" value="3.7" spread="7.71"/>
                    <measurement group_id="O3" value="4.2" spread="6.68"/>
                    <measurement group_id="O4" value="3.0" spread="6.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Component Summary Score at Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="101"/>
                    <count group_id="O3" value="105"/>
                    <count group_id="O4" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="7.04"/>
                    <measurement group_id="O2" value="4.0" spread="7.56"/>
                    <measurement group_id="O3" value="4.4" spread="5.81"/>
                    <measurement group_id="O4" value="3.4" spread="6.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Component Summary Score at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="99"/>
                    <count group_id="O4" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="7.08"/>
                    <measurement group_id="O2" value="4.6" spread="7.57"/>
                    <measurement group_id="O3" value="5.4" spread="7.63"/>
                    <measurement group_id="O4" value="2.8" spread="7.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Component Summary Score at Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="93"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="8.03"/>
                    <measurement group_id="O2" value="3.8" spread="7.36"/>
                    <measurement group_id="O3" value="5.4" spread="7.24"/>
                    <measurement group_id="O4" value="3.8" spread="6.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Component Summary Score at Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="7.11"/>
                    <measurement group_id="O2" value="4.6" spread="7.97"/>
                    <measurement group_id="O3" value="5.7" spread="7.76"/>
                    <measurement group_id="O4" value="4.1" spread="8.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Component Summary Score at Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="87"/>
                    <count group_id="O4" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="8.32"/>
                    <measurement group_id="O2" value="5.4" spread="7.05"/>
                    <measurement group_id="O3" value="6.5" spread="8.58"/>
                    <measurement group_id="O4" value="4.8" spread="7.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Component Summary Score at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="114"/>
                    <count group_id="O3" value="112"/>
                    <count group_id="O4" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="9.38"/>
                    <measurement group_id="O2" value="1.7" spread="9.25"/>
                    <measurement group_id="O3" value="1.9" spread="7.93"/>
                    <measurement group_id="O4" value="2.4" spread="7.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Component Summary Score at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="109"/>
                    <count group_id="O4" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="8.59"/>
                    <measurement group_id="O2" value="2.2" spread="8.81"/>
                    <measurement group_id="O3" value="1.6" spread="8.48"/>
                    <measurement group_id="O4" value="3.6" spread="9.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Component Summary Score at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="103"/>
                    <count group_id="O4" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="10.07"/>
                    <measurement group_id="O2" value="3.1" spread="8.45"/>
                    <measurement group_id="O3" value="0.8" spread="10.39"/>
                    <measurement group_id="O4" value="2.9" spread="8.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Component Summary Score at Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="101"/>
                    <count group_id="O3" value="105"/>
                    <count group_id="O4" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="9.84"/>
                    <measurement group_id="O2" value="2.5" spread="8.39"/>
                    <measurement group_id="O3" value="2.8" spread="9.39"/>
                    <measurement group_id="O4" value="2.9" spread="9.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Component Summary Score at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="99"/>
                    <count group_id="O4" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="9.75"/>
                    <measurement group_id="O2" value="2.4" spread="8.41"/>
                    <measurement group_id="O3" value="3.4" spread="9.68"/>
                    <measurement group_id="O4" value="2.7" spread="8.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Component Summary Score at Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="93"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="8.55"/>
                    <measurement group_id="O2" value="1.8" spread="9.51"/>
                    <measurement group_id="O3" value="2.8" spread="9.71"/>
                    <measurement group_id="O4" value="4.3" spread="9.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Component Summary Score at Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="8.81"/>
                    <measurement group_id="O2" value="1.5" spread="10.55"/>
                    <measurement group_id="O3" value="3.2" spread="9.81"/>
                    <measurement group_id="O4" value="4.0" spread="9.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Component Summary Score at Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="87"/>
                    <count group_id="O4" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="9.45"/>
                    <measurement group_id="O2" value="1.7" spread="9.91"/>
                    <measurement group_id="O3" value="3.9" spread="11.21"/>
                    <measurement group_id="O4" value="4.6" spread="9.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52</title>
        <description>The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L profile defines health in terms of mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has five levels: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, and 5: extreme problems. Responses were used to generate a weighted summary index (EQ-5D index), which ranges from 0 (dead) to 1.00 (perfect health). A higher score indicates better health and positive changes from baseline indicate improvement of health.</description>
        <time_frame>Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52</time_frame>
        <population>Quality of Life analysis set included all randomized participants who had received at least 1 dose of IMP (Evobrutinib or placebo) and had at least 1 Baseline and 1 post baseline QoL assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52</title>
          <description>The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L profile defines health in terms of mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has five levels: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, and 5: extreme problems. Responses were used to generate a weighted summary index (EQ-5D index), which ranges from 0 (dead) to 1.00 (perfect health). A higher score indicates better health and positive changes from baseline indicate improvement of health.</description>
          <population>Quality of Life analysis set included all randomized participants who had received at least 1 dose of IMP (Evobrutinib or placebo) and had at least 1 Baseline and 1 post baseline QoL assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</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="110"/>
                <count group_id="O2" value="114"/>
                <count group_id="O3" value="112"/>
                <count group_id="O4" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="114"/>
                    <count group_id="O3" value="112"/>
                    <count group_id="O4" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.036" spread="0.1626"/>
                    <measurement group_id="O2" value="0.045" spread="0.1931"/>
                    <measurement group_id="O3" value="0.036" spread="0.1618"/>
                    <measurement group_id="O4" value="0.038" spread="0.1908"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="109"/>
                    <count group_id="O4" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.034" spread="0.2164"/>
                    <measurement group_id="O2" value="0.064" spread="0.2505"/>
                    <measurement group_id="O3" value="0.046" spread="0.1842"/>
                    <measurement group_id="O4" value="0.061" spread="0.1603"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="103"/>
                    <count group_id="O4" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.061" spread="0.2014"/>
                    <measurement group_id="O2" value="0.070" spread="0.2189"/>
                    <measurement group_id="O3" value="0.055" spread="0.1912"/>
                    <measurement group_id="O4" value="0.065" spread="0.1732"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="101"/>
                    <count group_id="O3" value="105"/>
                    <count group_id="O4" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.083" spread="0.1818"/>
                    <measurement group_id="O2" value="0.072" spread="0.2252"/>
                    <measurement group_id="O3" value="0.067" spread="0.2287"/>
                    <measurement group_id="O4" value="0.056" spread="0.1738"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="99"/>
                    <count group_id="O4" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.080" spread="0.1901"/>
                    <measurement group_id="O2" value="0.067" spread="0.2271"/>
                    <measurement group_id="O3" value="0.086" spread="0.2110"/>
                    <measurement group_id="O4" value="0.055" spread="0.1817"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="93"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.083" spread="0.1758"/>
                    <measurement group_id="O2" value="0.067" spread="0.2262"/>
                    <measurement group_id="O3" value="0.075" spread="0.2009"/>
                    <measurement group_id="O4" value="0.071" spread="0.1941"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.093" spread="0.1521"/>
                    <measurement group_id="O2" value="0.061" spread="0.1850"/>
                    <measurement group_id="O3" value="0.090" spread="0.1853"/>
                    <measurement group_id="O4" value="0.084" spread="0.2172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="87"/>
                    <count group_id="O4" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.096" spread="0.2092"/>
                    <measurement group_id="O2" value="0.078" spread="0.2197"/>
                    <measurement group_id="O3" value="0.102" spread="0.2224"/>
                    <measurement group_id="O4" value="0.096" spread="0.2051"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52</title>
        <description>The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L profile defines health in terms of mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has five levels: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, and 5: extreme problems. The responses were used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 was the worst health you can imagine and 100 was the best health you can imagine.</description>
        <time_frame>Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52</time_frame>
        <population>Quality of Life analysis set included all randomized participants who had received at least 1 dose of IMP (Evobrutinib or placebo) and had at least 1 Baseline and 1 post baseline QoL assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52</title>
          <description>The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L profile defines health in terms of mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has five levels: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, and 5: extreme problems. The responses were used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 was the worst health you can imagine and 100 was the best health you can imagine.</description>
          <population>Quality of Life analysis set included all randomized participants who had received at least 1 dose of IMP (Evobrutinib or placebo) and had at least 1 Baseline and 1 post baseline QoL assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</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="110"/>
                <count group_id="O2" value="114"/>
                <count group_id="O3" value="112"/>
                <count group_id="O4" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="114"/>
                    <count group_id="O3" value="112"/>
                    <count group_id="O4" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread="16.8"/>
                    <measurement group_id="O2" value="2" spread="19.0"/>
                    <measurement group_id="O3" value="4" spread="17.6"/>
                    <measurement group_id="O4" value="4" spread="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="109"/>
                    <count group_id="O4" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread="18.8"/>
                    <measurement group_id="O2" value="6" spread="20.0"/>
                    <measurement group_id="O3" value="4" spread="14.5"/>
                    <measurement group_id="O4" value="6" spread="16.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="103"/>
                    <count group_id="O4" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" spread="19.7"/>
                    <measurement group_id="O2" value="6" spread="17.4"/>
                    <measurement group_id="O3" value="5" spread="17.2"/>
                    <measurement group_id="O4" value="4" spread="16.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="101"/>
                    <count group_id="O3" value="105"/>
                    <count group_id="O4" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" spread="19.3"/>
                    <measurement group_id="O2" value="5" spread="18.1"/>
                    <measurement group_id="O3" value="6" spread="18.5"/>
                    <measurement group_id="O4" value="4" spread="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="99"/>
                    <count group_id="O4" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" spread="18.7"/>
                    <measurement group_id="O2" value="5" spread="18.4"/>
                    <measurement group_id="O3" value="9" spread="20.4"/>
                    <measurement group_id="O4" value="4" spread="17.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="93"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" spread="17.2"/>
                    <measurement group_id="O2" value="4" spread="21.1"/>
                    <measurement group_id="O3" value="7" spread="17.8"/>
                    <measurement group_id="O4" value="7" spread="16.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" spread="18.1"/>
                    <measurement group_id="O2" value="6" spread="18.1"/>
                    <measurement group_id="O3" value="10" spread="19.5"/>
                    <measurement group_id="O4" value="8" spread="18.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="87"/>
                    <count group_id="O4" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" spread="19.9"/>
                    <measurement group_id="O2" value="8" spread="18.6"/>
                    <measurement group_id="O3" value="10" spread="21.3"/>
                    <measurement group_id="O4" value="10" spread="18.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52</title>
        <description>The Lupus QoL assessment is a 34 item questionnaire across 8 domains that is designed to find out how systemic lupus erythematosus (SLE) affects a participant's life. Domains include physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. Participants indicate their responses on a 5-point Likert response format, where 4=never, 3=occasionally, 2= a good bit of the time, 1=most of the time, and 0=worst of the time. Summary scores can be calculated for all 8 domains. A LupusQoL score for each domain was reported on a 0 to 100 scale, with greater values indicating better health related QoL.</description>
        <time_frame>Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52</time_frame>
        <population>Quality of Life analysis set included all randomized participants who had received at least 1 dose of IMP (Evobrutinib or placebo) and had at least 1 Baseline and 1 post baseline QoL assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52</title>
          <description>The Lupus QoL assessment is a 34 item questionnaire across 8 domains that is designed to find out how systemic lupus erythematosus (SLE) affects a participant's life. Domains include physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. Participants indicate their responses on a 5-point Likert response format, where 4=never, 3=occasionally, 2= a good bit of the time, 1=most of the time, and 0=worst of the time. Summary scores can be calculated for all 8 domains. A LupusQoL score for each domain was reported on a 0 to 100 scale, with greater values indicating better health related QoL.</description>
          <population>Quality of Life analysis set included all randomized participants who had received at least 1 dose of IMP (Evobrutinib or placebo) and had at least 1 Baseline and 1 post baseline QoL assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</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="110"/>
                <count group_id="O2" value="114"/>
                <count group_id="O3" value="112"/>
                <count group_id="O4" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Health Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="114"/>
                    <count group_id="O3" value="112"/>
                    <count group_id="O4" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="12.58"/>
                    <measurement group_id="O2" value="4.7" spread="17.68"/>
                    <measurement group_id="O3" value="4.0" spread="14.04"/>
                    <measurement group_id="O4" value="3.5" spread="13.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Health Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="109"/>
                    <count group_id="O4" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="15.20"/>
                    <measurement group_id="O2" value="6.3" spread="19.94"/>
                    <measurement group_id="O3" value="3.8" spread="17.64"/>
                    <measurement group_id="O4" value="4.6" spread="14.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Health Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="103"/>
                    <count group_id="O4" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="16.75"/>
                    <measurement group_id="O2" value="6.7" spread="19.78"/>
                    <measurement group_id="O3" value="5.6" spread="15.95"/>
                    <measurement group_id="O4" value="5.7" spread="14.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Health Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="101"/>
                    <count group_id="O3" value="105"/>
                    <count group_id="O4" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" spread="17.45"/>
                    <measurement group_id="O2" value="6.1" spread="18.71"/>
                    <measurement group_id="O3" value="7.4" spread="17.61"/>
                    <measurement group_id="O4" value="6.2" spread="15.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Health Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="99"/>
                    <count group_id="O4" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" spread="17.17"/>
                    <measurement group_id="O2" value="7.2" spread="18.59"/>
                    <measurement group_id="O3" value="8.4" spread="20.47"/>
                    <measurement group_id="O4" value="6.1" spread="13.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Health Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="93"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" spread="16.82"/>
                    <measurement group_id="O2" value="6.7" spread="19.45"/>
                    <measurement group_id="O3" value="9.4" spread="17.21"/>
                    <measurement group_id="O4" value="7.0" spread="16.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Health Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" spread="15.32"/>
                    <measurement group_id="O2" value="8.2" spread="17.38"/>
                    <measurement group_id="O3" value="9.6" spread="19.10"/>
                    <measurement group_id="O4" value="7.1" spread="17.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Health Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="87"/>
                    <count group_id="O4" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" spread="20.39"/>
                    <measurement group_id="O2" value="9.0" spread="18.44"/>
                    <measurement group_id="O3" value="11.6" spread="19.88"/>
                    <measurement group_id="O4" value="7.9" spread="18.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="114"/>
                    <count group_id="O3" value="112"/>
                    <count group_id="O4" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="16.30"/>
                    <measurement group_id="O2" value="6.7" spread="21.81"/>
                    <measurement group_id="O3" value="9.0" spread="20.90"/>
                    <measurement group_id="O4" value="5.7" spread="16.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="109"/>
                    <count group_id="O4" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="18.71"/>
                    <measurement group_id="O2" value="9.9" spread="24.65"/>
                    <measurement group_id="O3" value="7.3" spread="21.76"/>
                    <measurement group_id="O4" value="6.7" spread="18.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="103"/>
                    <count group_id="O4" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" spread="19.04"/>
                    <measurement group_id="O2" value="8.8" spread="24.00"/>
                    <measurement group_id="O3" value="9.8" spread="23.35"/>
                    <measurement group_id="O4" value="5.5" spread="14.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="101"/>
                    <count group_id="O3" value="105"/>
                    <count group_id="O4" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.4" spread="18.58"/>
                    <measurement group_id="O2" value="8.3" spread="25.60"/>
                    <measurement group_id="O3" value="10.5" spread="26.33"/>
                    <measurement group_id="O4" value="6.9" spread="15.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="99"/>
                    <count group_id="O4" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.4" spread="19.95"/>
                    <measurement group_id="O2" value="9.3" spread="24.31"/>
                    <measurement group_id="O3" value="13.0" spread="28.18"/>
                    <measurement group_id="O4" value="6.2" spread="17.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="93"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" spread="23.74"/>
                    <measurement group_id="O2" value="9.2" spread="24.60"/>
                    <measurement group_id="O3" value="12.8" spread="22.87"/>
                    <measurement group_id="O4" value="8.7" spread="17.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.0" spread="19.43"/>
                    <measurement group_id="O2" value="10.9" spread="23.68"/>
                    <measurement group_id="O3" value="15.3" spread="23.81"/>
                    <measurement group_id="O4" value="9.6" spread="20.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="87"/>
                    <count group_id="O4" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.2" spread="21.37"/>
                    <measurement group_id="O2" value="12.9" spread="22.64"/>
                    <measurement group_id="O3" value="14.9" spread="26.11"/>
                    <measurement group_id="O4" value="9.6" spread="19.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Planning Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="114"/>
                    <count group_id="O3" value="112"/>
                    <count group_id="O4" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="20.14"/>
                    <measurement group_id="O2" value="4.9" spread="19.64"/>
                    <measurement group_id="O3" value="5.4" spread="24.30"/>
                    <measurement group_id="O4" value="4.6" spread="18.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Planning Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="109"/>
                    <count group_id="O4" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" spread="23.32"/>
                    <measurement group_id="O2" value="8.4" spread="23.25"/>
                    <measurement group_id="O3" value="5.8" spread="25.14"/>
                    <measurement group_id="O4" value="3.9" spread="22.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Planning Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="103"/>
                    <count group_id="O4" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8" spread="23.58"/>
                    <measurement group_id="O2" value="5.8" spread="23.39"/>
                    <measurement group_id="O3" value="6.8" spread="25.74"/>
                    <measurement group_id="O4" value="5.1" spread="20.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Planning Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="101"/>
                    <count group_id="O3" value="105"/>
                    <count group_id="O4" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" spread="21.65"/>
                    <measurement group_id="O2" value="5.3" spread="24.12"/>
                    <measurement group_id="O3" value="6.5" spread="28.00"/>
                    <measurement group_id="O4" value="6.3" spread="22.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Planning Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="99"/>
                    <count group_id="O4" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9" spread="22.92"/>
                    <measurement group_id="O2" value="8.1" spread="23.55"/>
                    <measurement group_id="O3" value="11.5" spread="29.08"/>
                    <measurement group_id="O4" value="5.6" spread="21.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Planning Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="93"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" spread="24.82"/>
                    <measurement group_id="O2" value="7.6" spread="22.66"/>
                    <measurement group_id="O3" value="9.9" spread="25.90"/>
                    <measurement group_id="O4" value="6.9" spread="22.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Planning Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" spread="20.69"/>
                    <measurement group_id="O2" value="7.8" spread="23.19"/>
                    <measurement group_id="O3" value="11.6" spread="26.17"/>
                    <measurement group_id="O4" value="8.0" spread="23.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Planning Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="87"/>
                    <count group_id="O4" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.9" spread="22.38"/>
                    <measurement group_id="O2" value="7.0" spread="23.12"/>
                    <measurement group_id="O3" value="9.9" spread="28.29"/>
                    <measurement group_id="O4" value="10.5" spread="21.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intimate Relationship Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="88"/>
                    <count group_id="O3" value="80"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="26.11"/>
                    <measurement group_id="O2" value="1.6" spread="28.29"/>
                    <measurement group_id="O3" value="4.7" spread="24.06"/>
                    <measurement group_id="O4" value="3.2" spread="24.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intimate Relationship Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                    <count group_id="O2" value="81"/>
                    <count group_id="O3" value="75"/>
                    <count group_id="O4" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2" spread="30.31"/>
                    <measurement group_id="O2" value="4.2" spread="28.44"/>
                    <measurement group_id="O3" value="9.7" spread="29.10"/>
                    <measurement group_id="O4" value="3.7" spread="18.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intimate Relationship Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                    <count group_id="O2" value="75"/>
                    <count group_id="O3" value="65"/>
                    <count group_id="O4" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" spread="27.31"/>
                    <measurement group_id="O2" value="4.7" spread="25.65"/>
                    <measurement group_id="O3" value="2.3" spread="30.37"/>
                    <measurement group_id="O4" value="6.4" spread="21.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intimate Relationship Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="69"/>
                    <count group_id="O4" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8" spread="26.77"/>
                    <measurement group_id="O2" value="1.6" spread="30.76"/>
                    <measurement group_id="O3" value="3.8" spread="32.46"/>
                    <measurement group_id="O4" value="4.2" spread="22.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intimate Relationship Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="59"/>
                    <count group_id="O2" value="70"/>
                    <count group_id="O3" value="62"/>
                    <count group_id="O4" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" spread="30.12"/>
                    <measurement group_id="O2" value="2.1" spread="28.79"/>
                    <measurement group_id="O3" value="6.7" spread="30.76"/>
                    <measurement group_id="O4" value="5.3" spread="26.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intimate Relationship Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="66"/>
                    <count group_id="O3" value="54"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="28.77"/>
                    <measurement group_id="O2" value="1.3" spread="31.78"/>
                    <measurement group_id="O3" value="6.5" spread="29.41"/>
                    <measurement group_id="O4" value="1.4" spread="27.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intimate Relationship Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="61"/>
                    <count group_id="O3" value="55"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" spread="27.59"/>
                    <measurement group_id="O2" value="6.6" spread="27.91"/>
                    <measurement group_id="O3" value="6.4" spread="32.53"/>
                    <measurement group_id="O4" value="7.8" spread="22.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intimate Relationship Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="49"/>
                    <count group_id="O4" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4" spread="26.48"/>
                    <measurement group_id="O2" value="4.4" spread="28.36"/>
                    <measurement group_id="O3" value="8.4" spread="29.58"/>
                    <measurement group_id="O4" value="8.9" spread="24.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Burden to Others Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="114"/>
                    <count group_id="O3" value="112"/>
                    <count group_id="O4" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" spread="23.83"/>
                    <measurement group_id="O2" value="5.2" spread="22.84"/>
                    <measurement group_id="O3" value="6.8" spread="24.85"/>
                    <measurement group_id="O4" value="2.2" spread="24.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Burden to Others Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="109"/>
                    <count group_id="O4" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" spread="22.42"/>
                    <measurement group_id="O2" value="9.3" spread="27.17"/>
                    <measurement group_id="O3" value="5.7" spread="25.80"/>
                    <measurement group_id="O4" value="8.0" spread="25.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Burden to Others Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="103"/>
                    <count group_id="O4" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="25.86"/>
                    <measurement group_id="O2" value="6.7" spread="28.00"/>
                    <measurement group_id="O3" value="7.4" spread="25.93"/>
                    <measurement group_id="O4" value="7.3" spread="24.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Burden to Others Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="101"/>
                    <count group_id="O3" value="105"/>
                    <count group_id="O4" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8" spread="26.17"/>
                    <measurement group_id="O2" value="8.1" spread="23.32"/>
                    <measurement group_id="O3" value="6.7" spread="25.80"/>
                    <measurement group_id="O4" value="7.4" spread="24.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Burden to Others Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="99"/>
                    <count group_id="O4" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3" spread="28.68"/>
                    <measurement group_id="O2" value="9.0" spread="24.12"/>
                    <measurement group_id="O3" value="11.8" spread="27.15"/>
                    <measurement group_id="O4" value="5.8" spread="26.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Burden to Others Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="93"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6" spread="29.42"/>
                    <measurement group_id="O2" value="6.8" spread="24.09"/>
                    <measurement group_id="O3" value="9.6" spread="27.14"/>
                    <measurement group_id="O4" value="8.4" spread="28.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Burden to Others Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.1" spread="25.07"/>
                    <measurement group_id="O2" value="12.4" spread="21.91"/>
                    <measurement group_id="O3" value="12.4" spread="28.74"/>
                    <measurement group_id="O4" value="12.1" spread="25.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Burden to Others Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="87"/>
                    <count group_id="O4" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.3" spread="26.96"/>
                    <measurement group_id="O2" value="10.7" spread="22.13"/>
                    <measurement group_id="O3" value="13.0" spread="30.04"/>
                    <measurement group_id="O4" value="10.5" spread="25.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Health Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="114"/>
                    <count group_id="O3" value="112"/>
                    <count group_id="O4" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" spread="15.37"/>
                    <measurement group_id="O2" value="4.7" spread="18.48"/>
                    <measurement group_id="O3" value="4.2" spread="18.45"/>
                    <measurement group_id="O4" value="1.8" spread="16.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Health Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="109"/>
                    <count group_id="O4" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="15.15"/>
                    <measurement group_id="O2" value="7.0" spread="19.26"/>
                    <measurement group_id="O3" value="2.3" spread="19.51"/>
                    <measurement group_id="O4" value="5.3" spread="15.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Health Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="103"/>
                    <count group_id="O4" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" spread="17.23"/>
                    <measurement group_id="O2" value="7.6" spread="21.08"/>
                    <measurement group_id="O3" value="4.9" spread="20.99"/>
                    <measurement group_id="O4" value="4.7" spread="16.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Health Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="101"/>
                    <count group_id="O3" value="105"/>
                    <count group_id="O4" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" spread="15.86"/>
                    <measurement group_id="O2" value="7.5" spread="19.59"/>
                    <measurement group_id="O3" value="7.4" spread="18.56"/>
                    <measurement group_id="O4" value="6.2" spread="18.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Health Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="99"/>
                    <count group_id="O4" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" spread="17.31"/>
                    <measurement group_id="O2" value="5.6" spread="24.02"/>
                    <measurement group_id="O3" value="8.9" spread="20.97"/>
                    <measurement group_id="O4" value="4.3" spread="20.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Health Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="93"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" spread="17.07"/>
                    <measurement group_id="O2" value="4.3" spread="23.55"/>
                    <measurement group_id="O3" value="9.0" spread="22.66"/>
                    <measurement group_id="O4" value="6.0" spread="20.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Health Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.4" spread="16.08"/>
                    <measurement group_id="O2" value="8.3" spread="19.94"/>
                    <measurement group_id="O3" value="7.6" spread="21.52"/>
                    <measurement group_id="O4" value="6.7" spread="19.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Health Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="87"/>
                    <count group_id="O4" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" spread="17.43"/>
                    <measurement group_id="O2" value="6.4" spread="21.31"/>
                    <measurement group_id="O3" value="8.2" spread="22.77"/>
                    <measurement group_id="O4" value="7.6" spread="18.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body Image Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="97"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="17.70"/>
                    <measurement group_id="O2" value="8.4" spread="24.41"/>
                    <measurement group_id="O3" value="2.5" spread="24.60"/>
                    <measurement group_id="O4" value="4.0" spread="18.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body Image Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="92"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" spread="18.37"/>
                    <measurement group_id="O2" value="7.5" spread="23.40"/>
                    <measurement group_id="O3" value="-1.3" spread="27.06"/>
                    <measurement group_id="O4" value="6.5" spread="17.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body Image Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="83"/>
                    <count group_id="O4" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" spread="18.57"/>
                    <measurement group_id="O2" value="7.1" spread="21.07"/>
                    <measurement group_id="O3" value="2.3" spread="26.86"/>
                    <measurement group_id="O4" value="6.6" spread="16.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body Image Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="82"/>
                    <count group_id="O3" value="85"/>
                    <count group_id="O4" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" spread="18.10"/>
                    <measurement group_id="O2" value="7.6" spread="23.11"/>
                    <measurement group_id="O3" value="-0.4" spread="25.31"/>
                    <measurement group_id="O4" value="5.7" spread="20.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body Image Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="75"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="75"/>
                    <count group_id="O4" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" spread="20.84"/>
                    <measurement group_id="O2" value="10.2" spread="20.47"/>
                    <measurement group_id="O3" value="5.8" spread="27.31"/>
                    <measurement group_id="O4" value="6.7" spread="21.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body Image Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="68"/>
                    <count group_id="O4" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" spread="20.08"/>
                    <measurement group_id="O2" value="8.1" spread="23.71"/>
                    <measurement group_id="O3" value="3.3" spread="24.99"/>
                    <measurement group_id="O4" value="5.8" spread="21.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body Image Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" spread="14.11"/>
                    <measurement group_id="O2" value="8.2" spread="23.99"/>
                    <measurement group_id="O3" value="4.6" spread="26.67"/>
                    <measurement group_id="O4" value="9.0" spread="18.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body Image Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" spread="16.92"/>
                    <measurement group_id="O2" value="9.8" spread="21.46"/>
                    <measurement group_id="O3" value="5.1" spread="27.30"/>
                    <measurement group_id="O4" value="7.8" spread="21.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="114"/>
                    <count group_id="O3" value="112"/>
                    <count group_id="O4" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" spread="16.71"/>
                    <measurement group_id="O2" value="4.3" spread="18.98"/>
                    <measurement group_id="O3" value="6.2" spread="19.91"/>
                    <measurement group_id="O4" value="3.9" spread="17.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="109"/>
                    <count group_id="O4" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="19.22"/>
                    <measurement group_id="O2" value="7.1" spread="21.31"/>
                    <measurement group_id="O3" value="4.9" spread="20.61"/>
                    <measurement group_id="O4" value="4.5" spread="16.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="103"/>
                    <count group_id="O4" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" spread="18.22"/>
                    <measurement group_id="O2" value="5.8" spread="21.30"/>
                    <measurement group_id="O3" value="7.3" spread="23.11"/>
                    <measurement group_id="O4" value="5.0" spread="16.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="101"/>
                    <count group_id="O3" value="105"/>
                    <count group_id="O4" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" spread="17.61"/>
                    <measurement group_id="O2" value="6.6" spread="21.39"/>
                    <measurement group_id="O3" value="7.1" spread="24.16"/>
                    <measurement group_id="O4" value="4.1" spread="15.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="99"/>
                    <count group_id="O4" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" spread="19.06"/>
                    <measurement group_id="O2" value="4.8" spread="23.34"/>
                    <measurement group_id="O3" value="9.0" spread="26.00"/>
                    <measurement group_id="O4" value="3.6" spread="14.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="93"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" spread="19.20"/>
                    <measurement group_id="O2" value="3.7" spread="22.71"/>
                    <measurement group_id="O3" value="8.5" spread="22.96"/>
                    <measurement group_id="O4" value="4.1" spread="17.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.3" spread="20.03"/>
                    <measurement group_id="O2" value="6.1" spread="25.28"/>
                    <measurement group_id="O3" value="11.0" spread="25.18"/>
                    <measurement group_id="O4" value="5.3" spread="16.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="87"/>
                    <count group_id="O4" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9" spread="21.15"/>
                    <measurement group_id="O2" value="4.5" spread="24.78"/>
                    <measurement group_id="O3" value="11.2" spread="22.56"/>
                    <measurement group_id="O4" value="6.7" spread="17.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening</title>
        <description>The PGIC is a self-rated scale that asks the participant to describe the change in activity limitations, symptoms, emotions, and overall quality of life (QoL) related to the participants painful condition on the following scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse). Number of participants in the PGIC categories of any improvement (that is PGIC scale score 1, 2 or 3), no change (that is PGIC scale score 4) and any worsening (that is PGIC scale score 5, 6 or 7) are reported.</description>
        <time_frame>Week 4, 8, 12, 16, 24, 32, 40, and 52</time_frame>
        <population>Quality of Life analysis set included all randomized participants who had received at least 1 dose of IMP (Evobrutinib or placebo) and had at least 1 Baseline and 1 post baseline QoL assessment. Here,&quot;Number Analyzed&quot; signified those participants who were evaluable at given time points.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening</title>
          <description>The PGIC is a self-rated scale that asks the participant to describe the change in activity limitations, symptoms, emotions, and overall quality of life (QoL) related to the participants painful condition on the following scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse). Number of participants in the PGIC categories of any improvement (that is PGIC scale score 1, 2 or 3), no change (that is PGIC scale score 4) and any worsening (that is PGIC scale score 5, 6 or 7) are reported.</description>
          <population>Quality of Life analysis set included all randomized participants who had received at least 1 dose of IMP (Evobrutinib or placebo) and had at least 1 Baseline and 1 post baseline QoL assessment. Here,&quot;Number Analyzed&quot; signified those participants who were evaluable at given time points.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="114"/>
                <count group_id="O3" value="113"/>
                <count group_id="O4" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="114"/>
                    <count group_id="O3" value="113"/>
                    <count group_id="O4" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Any Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                    <measurement group_id="O2" value="78"/>
                    <measurement group_id="O3" value="81"/>
                    <measurement group_id="O4" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="23"/>
                    <measurement group_id="O4" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Any Worsening</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="110"/>
                    <count group_id="O3" value="110"/>
                    <count group_id="O4" value="109"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Any Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="81"/>
                    <measurement group_id="O3" value="85"/>
                    <measurement group_id="O4" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="19"/>
                    <measurement group_id="O4" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Any Worsening</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="105"/>
                    <count group_id="O3" value="107"/>
                    <count group_id="O4" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Any Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="78"/>
                    <measurement group_id="O2" value="82"/>
                    <measurement group_id="O3" value="81"/>
                    <measurement group_id="O4" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Any Worsening</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                    <count group_id="O2" value="101"/>
                    <count group_id="O3" value="105"/>
                    <count group_id="O4" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Any Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="81"/>
                    <measurement group_id="O3" value="87"/>
                    <measurement group_id="O4" value="79"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Any Worsening</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Any Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                    <measurement group_id="O2" value="77"/>
                    <measurement group_id="O3" value="87"/>
                    <measurement group_id="O4" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Any Worsening</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="95"/>
                    <count group_id="O4" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Any Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="70"/>
                    <measurement group_id="O3" value="80"/>
                    <measurement group_id="O4" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Any Worsening</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="93"/>
                    <count group_id="O4" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Any Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                    <measurement group_id="O2" value="69"/>
                    <measurement group_id="O3" value="80"/>
                    <measurement group_id="O4" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Any Worsening</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="90"/>
                    <count group_id="O4" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Any Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                    <measurement group_id="O2" value="64"/>
                    <measurement group_id="O3" value="76"/>
                    <measurement group_id="O4" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Any Worsening</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52</title>
        <description>The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assess self reported fatigue and its impact upon daily activities and function. It uses a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse possible score) to 52 (best score). A higher score reflected an improvement in the participant's health status.</description>
        <time_frame>Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52</time_frame>
        <population>Quality of Life analysis set included all randomized participants who had received at least 1 dose of IMP (Evobrutinib or placebo) and had at least 1 Baseline and 1 post baseline QoL assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52</title>
          <description>The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assess self reported fatigue and its impact upon daily activities and function. It uses a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse possible score) to 52 (best score). A higher score reflected an improvement in the participant's health status.</description>
          <population>Quality of Life analysis set included all randomized participants who had received at least 1 dose of IMP (Evobrutinib or placebo) and had at least 1 Baseline and 1 post baseline QoL assessment. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</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="110"/>
                <count group_id="O2" value="114"/>
                <count group_id="O3" value="112"/>
                <count group_id="O4" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="114"/>
                    <count group_id="O3" value="112"/>
                    <count group_id="O4" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread="8.0"/>
                    <measurement group_id="O2" value="2" spread="7.8"/>
                    <measurement group_id="O3" value="4" spread="9.1"/>
                    <measurement group_id="O4" value="3" spread="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="109"/>
                    <count group_id="O4" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread="8.7"/>
                    <measurement group_id="O2" value="3" spread="8.3"/>
                    <measurement group_id="O3" value="3" spread="9.1"/>
                    <measurement group_id="O4" value="5" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="103"/>
                    <count group_id="O4" value="101"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread="10.0"/>
                    <measurement group_id="O2" value="4" spread="9.7"/>
                    <measurement group_id="O3" value="3" spread="9.7"/>
                    <measurement group_id="O4" value="4" spread="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="101"/>
                    <count group_id="O3" value="105"/>
                    <count group_id="O4" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" spread="9.8"/>
                    <measurement group_id="O2" value="3" spread="9.8"/>
                    <measurement group_id="O3" value="4" spread="10.2"/>
                    <measurement group_id="O4" value="3" spread="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="99"/>
                    <count group_id="O4" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread="9.9"/>
                    <measurement group_id="O2" value="4" spread="8.5"/>
                    <measurement group_id="O3" value="5" spread="10.3"/>
                    <measurement group_id="O4" value="3" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="93"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" spread="9.6"/>
                    <measurement group_id="O2" value="4" spread="9.5"/>
                    <measurement group_id="O3" value="5" spread="9.7"/>
                    <measurement group_id="O4" value="4" spread="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" spread="8.8"/>
                    <measurement group_id="O2" value="3" spread="8.6"/>
                    <measurement group_id="O3" value="6" spread="9.9"/>
                    <measurement group_id="O4" value="4" spread="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="84"/>
                    <count group_id="O3" value="87"/>
                    <count group_id="O4" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" spread="9.9"/>
                    <measurement group_id="O2" value="4" spread="7.9"/>
                    <measurement group_id="O3" value="5" spread="9.7"/>
                    <measurement group_id="O4" value="5" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Number of Participants With Change From Baseline in Prednisone Equivalent Corticosteroid (CS) Dose by &gt;=25% to a Dose of &lt;=7.5 Milligram Per Day (mg/Day), With no BILAG A or 2B Flare in Disease Activity at Week 52</title>
        <description>BILAG A or 2B flare is defined as at least one BILAG A grade or two BILAG B grade in any organ system due to items that are new or worse, compared to the BILAG evaluation at the previous visit, during the 52 week treatment period. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to systemic lupus erythematosus (SLE), divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected.</description>
        <time_frame>Baseline and Week 52</time_frame>
        <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Number of Participants With Change From Baseline in Prednisone Equivalent Corticosteroid (CS) Dose by &gt;=25% to a Dose of &lt;=7.5 Milligram Per Day (mg/Day), With no BILAG A or 2B Flare in Disease Activity at Week 52</title>
          <description>BILAG A or 2B flare is defined as at least one BILAG A grade or two BILAG B grade in any organ system due to items that are new or worse, compared to the BILAG evaluation at the previous visit, during the 52 week treatment period. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to systemic lupus erythematosus (SLE), divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected.</description>
          <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="70"/>
                <count group_id="O4" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Rate difference</param_type>
            <param_value>5.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.7</ci_lower_limit>
            <ci_upper_limit>21.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Rate Difference</param_type>
            <param_value>0.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.5</ci_lower_limit>
            <ci_upper_limit>15.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Rate difference</param_type>
            <param_value>1.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.5</ci_lower_limit>
            <ci_upper_limit>16.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</title>
        <description>Change From Baseline in Prednisone-equivalent CS Daily Dose at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 were reported.</description>
        <time_frame>Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</time_frame>
        <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. . Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</title>
          <description>Change From Baseline in Prednisone-equivalent CS Daily Dose at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 were reported.</description>
          <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. . Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; signified those participants who were evaluable for the specified category at given time points.</population>
          <units>Milligram (mg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="113"/>
                <count group_id="O2" value="113"/>
                <count group_id="O3" value="116"/>
                <count group_id="O4" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="58"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21" spread="1.443"/>
                    <measurement group_id="O2" value="0.00" spread="0.000"/>
                    <measurement group_id="O3" value="0.00" spread="0.000"/>
                    <measurement group_id="O4" value="0.00" spread="0.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="113"/>
                    <count group_id="O2" value="113"/>
                    <count group_id="O3" value="116"/>
                    <count group_id="O4" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="1.206"/>
                    <measurement group_id="O2" value="-0.07" spread="0.524"/>
                    <measurement group_id="O3" value="0.00" spread="0.000"/>
                    <measurement group_id="O4" value="-0.13" spread="1.405"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="113"/>
                    <count group_id="O3" value="115"/>
                    <count group_id="O4" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="1.267"/>
                    <measurement group_id="O2" value="-0.45" spread="2.879"/>
                    <measurement group_id="O3" value="-0.04" spread="0.739"/>
                    <measurement group_id="O4" value="-0.15" spread="1.428"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="55"/>
                    <count group_id="O4" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.07" spread="3.563"/>
                    <measurement group_id="O2" value="-0.64" spread="3.275"/>
                    <measurement group_id="O3" value="-0.59" spread="2.095"/>
                    <measurement group_id="O4" value="-0.70" spread="3.484"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="108"/>
                    <count group_id="O2" value="110"/>
                    <count group_id="O3" value="110"/>
                    <count group_id="O4" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.57" spread="2.588"/>
                    <measurement group_id="O2" value="-1.24" spread="3.915"/>
                    <measurement group_id="O3" value="-1.09" spread="3.640"/>
                    <measurement group_id="O4" value="-1.02" spread="3.422"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="61"/>
                    <count group_id="O4" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.43" spread="3.985"/>
                    <measurement group_id="O2" value="-2.04" spread="5.146"/>
                    <measurement group_id="O3" value="-1.56" spread="4.137"/>
                    <measurement group_id="O4" value="-2.50" spread="4.971"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="107"/>
                    <count group_id="O4" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.26" spread="3.260"/>
                    <measurement group_id="O2" value="-1.85" spread="4.158"/>
                    <measurement group_id="O3" value="-1.73" spread="4.574"/>
                    <measurement group_id="O4" value="-1.97" spread="4.150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="63"/>
                    <count group_id="O4" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.00" spread="4.569"/>
                    <measurement group_id="O2" value="-2.70" spread="5.428"/>
                    <measurement group_id="O3" value="-1.87" spread="4.489"/>
                    <measurement group_id="O4" value="-2.76" spread="5.125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="101"/>
                    <count group_id="O3" value="104"/>
                    <count group_id="O4" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.67" spread="4.427"/>
                    <measurement group_id="O2" value="-2.70" spread="4.955"/>
                    <measurement group_id="O3" value="-2.47" spread="5.365"/>
                    <measurement group_id="O4" value="-2.40" spread="4.535"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.94" spread="4.054"/>
                    <measurement group_id="O2" value="-2.82" spread="4.905"/>
                    <measurement group_id="O3" value="-2.64" spread="5.489"/>
                    <measurement group_id="O4" value="-2.53" spread="4.727"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="99"/>
                    <count group_id="O4" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.99" spread="4.228"/>
                    <measurement group_id="O2" value="-2.64" spread="5.066"/>
                    <measurement group_id="O3" value="-2.61" spread="5.568"/>
                    <measurement group_id="O4" value="-2.34" spread="5.330"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="97"/>
                    <count group_id="O4" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.23" spread="4.439"/>
                    <measurement group_id="O2" value="-2.97" spread="4.981"/>
                    <measurement group_id="O3" value="-3.07" spread="6.068"/>
                    <measurement group_id="O4" value="-2.46" spread="5.371"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="95"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.45" spread="4.584"/>
                    <measurement group_id="O2" value="-3.13" spread="5.193"/>
                    <measurement group_id="O3" value="-3.18" spread="6.161"/>
                    <measurement group_id="O4" value="-2.44" spread="5.347"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="95"/>
                    <count group_id="O4" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.42" spread="4.835"/>
                    <measurement group_id="O2" value="-3.31" spread="5.327"/>
                    <measurement group_id="O3" value="-3.18" spread="6.136"/>
                    <measurement group_id="O4" value="-2.37" spread="5.445"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.08" spread="6.149"/>
                    <measurement group_id="O2" value="-3.21" spread="5.280"/>
                    <measurement group_id="O3" value="-3.24" spread="6.218"/>
                    <measurement group_id="O4" value="-2.67" spread="5.202"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.42" spread="4.833"/>
                    <measurement group_id="O2" value="-3.21" spread="5.280"/>
                    <measurement group_id="O3" value="-3.27" spread="6.254"/>
                    <measurement group_id="O4" value="-2.56" spread="5.121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.38" spread="4.895"/>
                    <measurement group_id="O2" value="-3.22" spread="5.310"/>
                    <measurement group_id="O3" value="-3.37" spread="6.265"/>
                    <measurement group_id="O4" value="-2.62" spread="5.136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="100"/>
                    <count group_id="O4" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.70" spread="5.470"/>
                    <measurement group_id="O2" value="-2.94" spread="5.534"/>
                    <measurement group_id="O3" value="-3.09" spread="5.981"/>
                    <measurement group_id="O4" value="-2.63" spread="5.673"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by &gt; 0 to 25%, &gt;25% to 50%, &gt;50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</title>
        <description>Number of Participants With Reduction From Baseline in Prednisone-equivalent Corticosteroid (CS) Daily Dose by &gt; 0 to 25%, &gt;25% to 50%, &gt;50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 were reported.</description>
        <time_frame>Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52</time_frame>
        <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by &gt; 0 to 25%, &gt;25% to 50%, &gt;50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52</title>
          <description>Number of Participants With Reduction From Baseline in Prednisone-equivalent Corticosteroid (CS) Daily Dose by &gt; 0 to 25%, &gt;25% to 50%, &gt;50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 were reported.</description>
          <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="115"/>
                <count group_id="O3" value="116"/>
                <count group_id="O4" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Reduction of dose by &gt;0-25% Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;0-25% Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;0-25% Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;0-25% Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;0-25% Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;0-25% Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;0-25% Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;0-25% Week 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;0-25% Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;0-25% Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;0-25% Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;0-25% Week 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;0-25% Week 32</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;0-25% Week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;0-25% Week 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;0-25% Week 44</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;0-25% Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;0-25% Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;25- 50% Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;25- 50% Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;25- 50% Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;25- 50% Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;25- 50% Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;25- 50% Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;25- 50% Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;25- 50% Week 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;25- 50% Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;25- 50% Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;25- 50% Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;25- 50% Week 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;25- 50% Week 32</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;25- 50% Week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;25- 50% Week 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;25- 50% Week 44</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;25- 50% Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;25- 50% Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;50-100% Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;50-100% Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;50-100% Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;50-100% Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;50-100% Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;50-100% Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;50-100% Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;50-100% Week 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;50-100% Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;50-100% Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;50-100% Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;50-100% Week 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;50-100% Week 32</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;50-100% Week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;50-100% Week 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;50-100% Week 44</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;50-100% Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="19"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reduction of dose by &gt;50-100% Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="19"/>
                    <measurement group_id="O4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increased from Baseline Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increased from Baseline Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increased from Baseline Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increased from Baseline Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increased from Baseline Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increased from Baseline Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increased from Baseline Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increased from Baseline Week 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increased from Baseline Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increased from Baseline Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increased from Baseline Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increased from Baseline Week 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increased from Baseline Week 32</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increased from Baseline Week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increased from Baseline Week 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increased from Baseline Week 44</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increased from Baseline Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increased from Baseline Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Cumulative Prednisone Equivalent Corticosteroid (CS) Dose at Week 52</title>
        <description>Cumulative Prednisone-equivalent Corticosteroid (CS) Dose was calculated at Week 52.</description>
        <time_frame>Week 52</time_frame>
        <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Cumulative Prednisone Equivalent Corticosteroid (CS) Dose at Week 52</title>
          <description>Cumulative Prednisone-equivalent Corticosteroid (CS) Dose was calculated at Week 52.</description>
          <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI.</population>
          <units>Milligrams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="115"/>
                <count group_id="O3" value="116"/>
                <count group_id="O4" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2267.66" spread="1507.652"/>
                    <measurement group_id="O2" value="2209.46" spread="1922.557"/>
                    <measurement group_id="O3" value="2137.70" spread="1618.688"/>
                    <measurement group_id="O4" value="2205.56" spread="1737.092"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52</title>
        <description>SRI-4 response was defined as greater than or equal to (&gt;=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).</description>
        <time_frame>Week 52</time_frame>
        <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52</title>
          <description>SRI-4 response was defined as greater than or equal to (&gt;=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).</description>
          <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="63"/>
                <count group_id="O4" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="45"/>
                    <measurement group_id="O3" value="43"/>
                    <measurement group_id="O4" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7728</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.46</ci_lower_limit>
            <ci_upper_limit>2.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3314</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.28</ci_lower_limit>
            <ci_upper_limit>1.54</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7205</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.36</ci_lower_limit>
            <ci_upper_limit>2.04</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52</title>
        <description>SRI-6 response was defined as &gt;= 6-point reduction in SLEDAI-2K total score, no new BILAG A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system :A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).</description>
        <time_frame>Week 52</time_frame>
        <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;overall number of participants analyzed&quot; signifies those participants who achieved SLEDAI-2K total score &gt;= 10 at screening (HDA participants) and evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52</title>
          <description>SRI-6 response was defined as &gt;= 6-point reduction in SLEDAI-2K total score, no new BILAG A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system :A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).</description>
          <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;overall number of participants analyzed&quot; signifies those participants who achieved SLEDAI-2K total score &gt;= 10 at screening (HDA participants) and evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="35"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="23"/>
                    <measurement group_id="O4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8364</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.35</ci_lower_limit>
            <ci_upper_limit>3.71</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8287</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.37</ci_lower_limit>
            <ci_upper_limit>3.45</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7621</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.35</ci_lower_limit>
            <ci_upper_limit>4.16</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on SRI-4 at Week 52 in Serologically Active Subgroup</title>
        <description>SRI-4 response was defined as greater than or equal to (&gt;=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale = from very well(0)-very poor(100).</description>
        <time_frame>Week 52</time_frame>
        <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants with positive antidsDNA and/or low complement levels at screening (Serologically active subgroup) and evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on SRI-4 at Week 52 in Serologically Active Subgroup</title>
          <description>SRI-4 response was defined as greater than or equal to (&gt;=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale = from very well(0)-very poor(100).</description>
          <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants with positive antidsDNA and/or low complement levels at screening (Serologically active subgroup) and evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="22"/>
                    <measurement group_id="O4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8464</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.23</ci_lower_limit>
            <ci_upper_limit>3.31</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4170</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.59</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.16</ci_lower_limit>
            <ci_upper_limit>2.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9988</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.27</ci_lower_limit>
            <ci_upper_limit>3.74</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DBPC Period: Number of Participants With Lupus Low Disease Activity State (LLDAS) at Week 52</title>
        <description>Lupus low disease activity state will be measured as: SLEDAI-2K &lt;= 4; No activity in any major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever); No new features of disease activity compared with the previous assessment; Prednisone-equivalent &lt;= 7.5 milligram per day; Unchanged background immunosuppressive therapy.</description>
        <time_frame>Week 52</time_frame>
        <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI.</population>
        <group_list>
          <group group_id="O1">
            <title>DBPC Period: Placebo</title>
            <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DBPC Period: M2951 25 mg QD</title>
            <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
          </group>
          <group group_id="O3">
            <title>DBPC Period: M2951 75 mg QD</title>
            <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
          </group>
          <group group_id="O4">
            <title>DBPC Period: M2951 50 mg BID</title>
            <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>DBPC Period: Number of Participants With Lupus Low Disease Activity State (LLDAS) at Week 52</title>
          <description>Lupus low disease activity state will be measured as: SLEDAI-2K &lt;= 4; No activity in any major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever); No new features of disease activity compared with the previous assessment; Prednisone-equivalent &lt;= 7.5 milligram per day; Unchanged background immunosuppressive therapy.</description>
          <population>The mITT analysis set included all randomized participants who had received at least one dose of IMP (Evobrutinib or placebo) and have at least one Baseline and one post Baseline disease assessment among the following: SFI, SLEDAI 2K, PGA, BILAG 2004, CLASI.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="115"/>
                <count group_id="O3" value="116"/>
                <count group_id="O4" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="35"/>
                    <measurement group_id="O4" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6970</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>2.04</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3234</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.34</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.75</ci_lower_limit>
            <ci_upper_limit>2.42</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9846</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.54</ci_lower_limit>
            <ci_upper_limit>1.82</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Double-Blind Placebo-Controlled: Baseline up to Week 56 Long-Term Extension: Up to Week 108</time_frame>
      <group_list>
        <group group_id="E1">
          <title>DBPC Period: Placebo</title>
          <description>Participants received placebo matched to M2951 orally for 52 weeks.</description>
        </group>
        <group group_id="E2">
          <title>DBPC Period: M2951 25 mg QD</title>
          <description>Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.</description>
        </group>
        <group group_id="E3">
          <title>DBPC Period: M2951 75 mg QD</title>
          <description>Participants received 75 mg of M2951 orally QD for 52 weeks.</description>
        </group>
        <group group_id="E4">
          <title>DBPC Period: M2951 50 mg BID</title>
          <description>Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.</description>
        </group>
        <group group_id="E5">
          <title>LTE: Placebo/ M2951 50 mg BID</title>
          <description>Participants who received Placebo in DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.</description>
        </group>
        <group group_id="E6">
          <title>LTE Period: M2951 25 mg QD/ M2951 50 mg BID</title>
          <description>Participants who received 25 mg of M2951 orally QD in DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.</description>
        </group>
        <group group_id="E7">
          <title>LTE Period: M2951 75 mg QD/ M2951 50 mg BID</title>
          <description>Participants who received 75 mg of M2951 orally QD in DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.</description>
        </group>
        <group group_id="E8">
          <title>LTE: M2951 50 mg BID/ M2951 50 mg BID</title>
          <description>Participants who received 50 mg of M2951 orally BID in DBPC period continued to receive same dose of M2951 orally BID in LTE period for 104 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA V22.1/23.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="7" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Bone marrow failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Pericarditis lupus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Lupus enteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Dental cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Abdominal adhesions</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Campylobacter sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Giardiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pneumonia mycoplasmal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Subperiosteal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ligament injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Liver function test increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Systemic lupus erythematosus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Osteonecrosis of jaw</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>SLE arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Papillary thyroid cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cerebral venous sinus thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </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" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Lupus nephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Uterine polyp</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Metrorrhagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Cutaneous vasculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Dermatosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Malignant hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA V22.1/23.0</default_vocab>
        <default_assessment>Non-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="76" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="85" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="75" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="78" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="22" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="34" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="35" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="23" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="21" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="118"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="117"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="72"/>
              </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>
    </certain_agreements>
    <limitations_and_caveats>Primary and Secondary endpoints were planned to be analyze only for Double-Blind Placebo-controlled period.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Communication Center</name_or_title>
      <organization>Merck KGaA, Darmstadt, Germany</organization>
      <phone>+49-6151-72-5200</phone>
      <email>service@emdgroup.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02975336
org study id: MS200527-0018
secondary id: 2016-002950-19
nct id: NCT02975336
lead sponsor: 
collaborator: 
has dmc: Yes
M2951 is an investigational drug under evaluation for treatment of autoimmune and
      inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of
      M2951 in participants with Systemic Lupus Erythematosus (SLE).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52
time frame: Week 52
description: SRI-4 response was defined as greater than or equal to (>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE) divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).
measure: DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52
time frame: Week 52
description: SRI-6 response was defined as >= 6-point reduction in SLEDAI-2K total score, no new BILAG A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system :A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).
measure: DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)
time frame: Baseline up to Week 56
description: Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs: events between first dose of study drug that were absent before treatment/that worsened relative to pre-treatment state up to 56 weeks. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs and serious TEAEs were reported.
measure: DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)
time frame: Baseline up to Week 56
description: Severity of TEAEs were graded using NCI-CTCAE v4.03 toxicity grades, as follows: Grade 1= Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening and Grade 5 = Death. Number of participants with TEAEs by severity were reported.
measure: DBPC Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
time frame: Baseline up to Week 56
description: Vital signs included body temperature, systolic and diastolic blood pressure, pulse rate, respiratory rate, weight and height. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in vital signs were reported.
measure: DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Findings
time frame: Baseline up to Week 56
description: 12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. The corrected QT interval (QTcF) was calculated using Fridericia's formula. 12-lead ECG recordings were obtained after the participants have rested for at least 10 minutes in semisupine position. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported.
measure: DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters
time frame: Baseline up to Week 56
description: Laboratory investigation included hematology, biochemistry, urinalysis and coagulation. Clinical significance was determined by the investigator. The number of participants with clinically significant changes from baseline in laboratory parameters were reported.
measure: DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2
time frame: Week 2
description: Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 2.
measure: DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4
time frame: Week 4
description: Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 4.
measure: DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12
time frame: Week 12
description: Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 12.
measure: DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24
time frame: Week 24
description: Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 24.
measure: DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36
time frame: Week 36
description: Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 36.
measure: DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52
time frame: Week 52
description: Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 52
measure: DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56
time frame: Week 56
description: Mean absolute value of serum levels of IgG, IgA, IgM were assessed at Week 56
measure: DBPC Period: Mean Absolute Total B Cell Count at Week 4
time frame: Week 4
description: Mean total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.
measure: DBPC Period: Mean Absolute Total B Cell Count at Week 24
time frame: Week 24
description: Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.
measure: DBPC Period: Mean Absolute Total B Cell Count at Week 52
time frame: Week 52
description: Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.
measure: DBPC Period: Mean Absolute Total B Cell Count at Week 56
time frame: Week 56
description: Mean absolute total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence activated cell sorting was performed for the analysis of B cell counts.
measure: DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2
time frame: Baseline and Week 2
description: Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
measure: DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4
time frame: Baseline and Week 4
description: Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
measure: DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12
time frame: Baseline and Week 12
description: Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
measure: DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24
time frame: Baseline and Week 24
description: Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
measure: DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36
time frame: Baseline and Week 36
description: Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
measure: DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52
time frame: Baseline and Week 52
description: Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
measure: DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56
time frame: Baseline and Week 56
description: Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
measure: DBPC Period: Change From Baseline in Total B Cell Count at Week 4
time frame: Baseline and Week 4
description: Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.
measure: DBPC Period: Change From Baseline in Total B Cell Count at Week 24
time frame: Baseline and Week 24
description: Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.
measure: DBPC Period: Change From Baseline in Total B Cell Count at Week 52
time frame: Baseline and Week 52
description: Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.
measure: DBPC Period: Change From Baseline in Total B Cell Count at Week 56
time frame: Baseline and Week 56
description: Change from baseline in Total B cell count were assessed. Flow cytometry analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of B cell counts.
measure: DBPC Period: Time to First Severe British Isles Lupus Assessment Group (BILAG) A Flare
time frame: Baseline up to Week 56
description: BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). Total BILAG score is sum of scores of 9 domains where A=12, B=8, C=1, D=0, and E=0. Total score ranges from 0 to 108 with a higher score indicating greater lupus activity. Time to first severe flare, where a severe flare is defined as at least one BILAG A (Severe disease activity) score in any organ system due to items that are new or worse, compared to the BILAG evaluation at the previous visit, during the 52-Week Treatment. It was measured using Kaplan-Meier (KM) estimates.
measure: DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52 in Serologically Active (SA) Subgroup
time frame: Week 52
description: SRI-4 response was defined as greater than or equal to (>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).
measure: DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52 in Serologically Active Subgroup
time frame: Week 52
description: SRI-6 response was defined as >= 6-point reduction in SLEDAI-2K total score, no new BILAG A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system :A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale = from 0(very well) to 100(very poor).
measure: DBPC Period: Time to First British Isles Lupus Assessment Group (BILAG) A or 2B Moderate to Severe Flare
time frame: Baseline up to Week 56
description: BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). Total BILAG score is sum of scores of 9 domains where A=12, B=8, C=1, D=0, and E=0. Total score ranges from 0 to 108 with a higher score indicating greater lupus activity. A Moderate to Severe (BILAG A or 2B) flare is defined as at least one BILAG A (severe disease activity) grade or two BILAG B (moderate disease activity) grade in any organ system due to items that are new or worse, compared to the BILAG evaluation at the previous visit, during the 52 week treatment. It was measured using Kaplan-Meier (KM) estimates.
measure: DBPC Period: Number of Participants With British Isles Lupus Assessment Group (BILAG) 2004 Flare-Free Status During the 52-Week Treatment Period
time frame: up to Week 52
description: A participant has a flare-free status if no flare has been reported during the 52-week treatment period. Participants who discontinued treatment prior to Week 52, without having a flare are counted as not being flare free at Week 52. A flare was defined as either 1 or more new BILAG-2004 A (severe disease activity) or 2 or more new BILAG-2004 B (moderate disease activity) items compared to the previous visit. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected.
measure: DBPC Period: Annualized Flare Rate
time frame: Baseline up to Week 52
description: A flare was defined as either 1 or more new BILAG-2004 A (severe disease activity) or 2 or more new BILAG-2004 B (moderate disease activity) items compared to the previous visit. The occurrence of a new flare was checked for each available visit versus the previous available visit up to Week 52. If no new flares occurred, the number of flares was set to 0. Otherwise all flares were counted leading to the maximum number of flares of 13. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25 (1 year). The flare exposure time is the time up to Week 52 (date of BILAG-2004 assessment at Week 52) or up to the date of last available BILAG 2004 assessment.
measure: DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (<= ) 2 at Week 52
time frame: Week 52
description: Low disease activity is defined as SLEDAI-2K score <=2. SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 30 days. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).
measure: DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Clinical Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (<= ) 2 at Week 52
time frame: Week 52
description: Low disease activity is defined as SLEDAI-2K score <=2. SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 30 days. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms). Clinical SLEDAI-2K score is equal to the SLEDAI-2K score from electronic case report form (eCRF) excluding the components 'Increased Deoxyribonucleic acid (DNA) Binding' and 'Low Complement'.
measure: DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
time frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
description: SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 30 days. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).
measure: DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
time frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
description: CLASI is an validated measurement instrument for lupus erythematosus developed for use in clinical studies that consists of separate scores for the activity of the disease (CLASI-A). The CLASI activity score is calculated on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI activity score ranges from 0-70, with higher scores indicating more severe skin disease. Severity categories based on the CLASI activity score are as follows: mild (0-9), moderate (10-20), and severe (21-70).
measure: DBPC Period: Number of Participants With Response Based on BILAG-Based Composite Lupus Assessment (BICLA) at Week 52
time frame: Week 52
description: BICLA response defined as participants meeting following criteria: [1] At least one gradation of improvement in baseline BILAG scores in all body systems with moderate or severe disease activity at entry (example: all A (severe disease) scores falling to B (moderate), C (mild), or D (no activity) and all B scores falling to C or D; [2] No new BILAG A or more than one new BILAG B scores; [3] No worsening of total SLEDAI-2K score from baseline; [4] No significant deterioration (=<10%) in physician's global assessment and [5] No treatment failure (initiation of non-protocol treatment).
measure: DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
time frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
description: BILAG 2004 disease activity Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). Total BILAG score is sum of scores of 9 domains where A=12, B=8, C=1, D=0, and E=0. Total score ranges from 0 to 108 with a higher score indicating greater lupus activity.
measure: DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
time frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
description: The Physician's Global Assessment of Disease Activity was recorded using the 100 millimeter horizontal Visual Analog Scale (VAS). Physician rated participant's disease activity on a scale ranged from 0-100 millimeter (mm), where 0 indicated no disease activity and 100 represented maximum disease activity.
measure: DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52
time frame: Baseline, Week 4, 8, 12, 16, 24, 32, 40 and 52
description: The 36-Item Short-Form Health Survey (SF-36) was a standardized survey evaluating 8 aspects of functional health and well-being. These eight subscales were summarized as relating to either physical health or mental health. Physical component summary (PCS) was based primarily on physical functioning, role-physical, bodily pain, and general health scales and mental component summary (MCS) encompasses vitality, social functioning, role-emotional, and mental health scales. Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0 - 100 (100 = highest level of mental functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100 = highest level of physical functioning).
measure: DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52
time frame: Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52
description: The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L profile defines health in terms of mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has five levels: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, and 5: extreme problems. Responses were used to generate a weighted summary index (EQ-5D index), which ranges from 0 (dead) to 1.00 (perfect health). A higher score indicates better health and positive changes from baseline indicate improvement of health.
measure: DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52
time frame: Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52
description: The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L profile defines health in terms of mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has five levels: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, and 5: extreme problems. The responses were used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 was the worst health you can imagine and 100 was the best health you can imagine.
measure: DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52
time frame: Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52
description: The Lupus QoL assessment is a 34 item questionnaire across 8 domains that is designed to find out how systemic lupus erythematosus (SLE) affects a participant's life. Domains include physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. Participants indicate their responses on a 5-point Likert response format, where 4=never, 3=occasionally, 2= a good bit of the time, 1=most of the time, and 0=worst of the time. Summary scores can be calculated for all 8 domains. A LupusQoL score for each domain was reported on a 0 to 100 scale, with greater values indicating better health related QoL.
measure: DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening
time frame: Week 4, 8, 12, 16, 24, 32, 40, and 52
description: The PGIC is a self-rated scale that asks the participant to describe the change in activity limitations, symptoms, emotions, and overall quality of life (QoL) related to the participants painful condition on the following scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse). Number of participants in the PGIC categories of any improvement (that is PGIC scale score 1, 2 or 3), no change (that is PGIC scale score 4) and any worsening (that is PGIC scale score 5, 6 or 7) are reported.
measure: DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52
time frame: Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52
description: The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assess self reported fatigue and its impact upon daily activities and function. It uses a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse possible score) to 52 (best score). A higher score reflected an improvement in the participant's health status.
measure: DBPC Period: Number of Participants With Change From Baseline in Prednisone Equivalent Corticosteroid (CS) Dose by >=25% to a Dose of <=7.5 Milligram Per Day (mg/Day), With no BILAG A or 2B Flare in Disease Activity at Week 52
time frame: Baseline and Week 52
description: BILAG A or 2B flare is defined as at least one BILAG A grade or two BILAG B grade in any organ system due to items that are new or worse, compared to the BILAG evaluation at the previous visit, during the 52 week treatment period. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to systemic lupus erythematosus (SLE), divided into 9 organ systems. For each organ system based on alphabetic score: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected.
measure: DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
time frame: Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
description: Change From Baseline in Prednisone-equivalent CS Daily Dose at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 were reported.
measure: DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
time frame: Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
description: Number of Participants With Reduction From Baseline in Prednisone-equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 were reported.
measure: DBPC Period: Cumulative Prednisone Equivalent Corticosteroid (CS) Dose at Week 52
time frame: Week 52
description: Cumulative Prednisone-equivalent Corticosteroid (CS) Dose was calculated at Week 52.
measure: DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52
time frame: Week 52
description: SRI-4 response was defined as greater than or equal to (>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).
measure: DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52
time frame: Week 52
description: SRI-6 response was defined as >= 6-point reduction in SLEDAI-2K total score, no new BILAG A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0 (no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system :A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale =from 0(very well) to 100(very poor).
measure: DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on SRI-4 at Week 52 in Serologically Active Subgroup
time frame: Week 52
description: SRI-4 response was defined as greater than or equal to (>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score, no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA) and no treatment failure. SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to Systemic Lupus Erythematosus (SLE), divided into 9 organ systems. For each organ system A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale = from very well(0)-very poor(100).
measure: DBPC Period: Number of Participants With Lupus Low Disease Activity State (LLDAS) at Week 52
time frame: Week 52
description: Lupus low disease activity state will be measured as: SLEDAI-2K <= 4; No activity in any major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever); No new features of disease activity compared with the previous assessment; Prednisone-equivalent <= 7.5 milligram per day; Unchanged background immunosuppressive therapy.
arm group label: Double-Blind Placebo-Controlled (DBPC) Period: Placebo
arm group type: Placebo Comparator
arm group label: DBPC Period: M2951 25 mg QD
arm group type: Experimental
arm group label: DBPC Period: M2951 75 mg QD
arm group type: Experimental
arm group label: DBPC Period: M2951 50 mg BID
arm group type: Experimental
arm group label: Long-Term Extension (LTE) Period: Placebo/ M2951 50 mg BID
arm group type: Experimental
arm group label: LTE Period: M2951 25 mg QD/ M2951 50 mg BID
arm group type: Experimental
arm group label: LTE Period: M2951 75 mg QD/ M2951 50 mg BID
arm group type: Experimental
arm group label: LTE Period: M2951 50 mg BID/ M2951 50 mg BID
arm group type: Experimental
intervention type: Drug
intervention name: Placebo
description: Participants received placebo matched to M2951 orally for 52 weeks.
arm group label: Double-Blind Placebo-Controlled (DBPC) Period: Placebo
intervention type: Drug
intervention name: M2951
description: Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.
arm group label: DBPC Period: M2951 25 mg QD
other name: Evobrutinib
intervention type: Drug
intervention name: M2951
description: Participants received 75 mg of M2951 orally QD for 52 weeks.
arm group label: DBPC Period: M2951 75 mg QD
other name: Evobrutinib
intervention type: Drug
intervention name: M2951
description: Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.
arm group label: DBPC Period: M2951 50 mg BID
other name: Evobrutinib
intervention type: Drug
intervention name: M2951
description: Participants who had received Placebo or M2951 (25 mg QD, 75 mg QD or 50 mg BID) during DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.
arm group label: LTE Period: M2951 25 mg QD/ M2951 50 mg BID
arm group label: LTE Period: M2951 50 mg BID/ M2951 50 mg BID
arm group label: LTE Period: M2951 75 mg QD/ M2951 50 mg BID
arm group label: Long-Term Extension (LTE) Period: Placebo/ M2951 50 mg BID
other name: Evobrutinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Medical Responsible
role: Study Director
affiliation: EMD Serono Research & Development Institute, Inc., a business of Merck KGaA, Darmstadt, Germany
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country: Argentina
country: Bulgaria
country: Chile
country: Colombia
country: Germany
country: Italy
country: Japan
country: Korea, Republic of
country: Malaysia
country: Mauritius
country: Mexico
country: Peru
country: Philippines
country: Poland
country: Romania
country: Russian Federation
country: South Africa
country: Taiwan
country: United States
url: https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS200527-0018
description: Trial Awareness and Transparency website
url: https://medical.emdserono.com/en_US/home.html
description: US Medical Information website, Medical Resources
responsible party type: Sponsor
mesh term: Lupus Erythematosus, Systemic
provided document: 
provided document: 
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outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Primary and Secondary endpoints were planned to be analyze only for Double-Blind Placebo-controlled period.
point of contact: 