<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/NCT02985879</url>
  </required_header>
  <id_info>
    <org_study_id>M15-562</org_study_id>
    <secondary_id>2016-001635-12</secondary_id>
    <nct_id>NCT02985879</nct_id>
  </id_info>
  <brief_title>A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to assess efficacy, safety, tolerability, and pharmacokinetics&#xD;
      of ABBV-8E12 in participants with progressive supranuclear palsy (PSP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a Phase 2, randomized, double-blind, placebo-controlled, multiple dose, multicenter&#xD;
      study consisting of a screening period of up to 8 weeks (56 days), a 52-week double-blind&#xD;
      treatment period, and a post-treatment follow-up period of approximately 20 weeks following&#xD;
      last study drug administration (for those participants who prematurely discontinued from&#xD;
      treatment, declined to participate in or did not qualify for participation in a long term&#xD;
      extension [LTE] study). At the end of the treatment period, extended treatment was available&#xD;
      for eligible participants who completed the 52-week treatment period and entered the separate&#xD;
      long-term extension study (NCT03391765; Study M15-563). There were 3 cohorts in the study&#xD;
      (Cohort 1, Cohort J1, and Cohort 2). Cohort 1 had augmented safety and pharmacokinetic (PK)&#xD;
      assessments in the first 30 participants enrolled into the global study from countries other&#xD;
      than Japan. Cohort J1 had augmented safety and PK assessments in the first 9 participants&#xD;
      enrolled into the study from Japan. Cohort 2 consisted of all other participants enrolled in&#xD;
      the global study not participating in Cohort 1 or Cohort J1.&#xD;
&#xD;
      This study was prematurely discontinued because the program for progressive supranuclear&#xD;
      palsy was discontinued due to lack of efficacy of study drug.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    This study was prematurely discontinued because the program for progressive supranuclear palsy&#xD;
    was discontinued due to lack of efficacy of study drug.&#xD;
  </why_stopped>
  <start_date type="Actual">December 12, 2016</start_date>
  <completion_date type="Actual">November 20, 2019</completion_date>
  <primary_completion_date type="Actual">November 20, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline to Week 52 in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score</measure>
    <time_frame>Baseline, Week 52</time_frame>
    <description>The PSPRS consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for six items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Positive changes in score indicate worsening from baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>From the first dose of study drug until 20 weeks following discontinuation of study drug administration have elapsed (approximately 5 half-lives), up to 80 weeks</time_frame>
    <description>An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity from first dose of study drug until 20 weeks after the last dose. For more details on AEs please see the Adverse Event section.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)</measure>
    <time_frame>Baseline, Week 52</time_frame>
    <description>The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions related to Activities of Daily Living, and ranges from 0-52. Higher scores are associated with more disability. Positive changes in score indicate worsening from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression of Change (CGI-C) Score at Week 52</measure>
    <time_frame>Week 52</time_frame>
    <description>The Clinical Global Impression of Change (CGI-C) score is a clinician's rating scale for assessing Global Improvement of Change. The CGI-C rates improvement by 7 categories: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), very much worse (7). The CGI-C score ranges from 1 to 7, with lower scores indicating improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to Week 52 in Midbrain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)</measure>
    <time_frame>Baseline, Week 52</time_frame>
    <description>Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify midbrain atrophy. Negative changes in values indicate a reduction in volume.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL)</measure>
    <time_frame>Baseline, Week 52</time_frame>
    <description>The Schwab and England Activities of Daily Living (SEADL) consists of ten items intended to evaluate the daily life activities of a participant. The SEADL is composed of two sections: the first is a self-reported questionnaire in which participants grade their own daily life activities, such as dressing, using the toilet, resting, eating, and social activities (subjective assessment), and the second is an assessment of motor functions, such as postural balance, speaking, rigidity, and tremors, conducted by a clinician (objective assessment). It is a percentage scale divided into deciles, and the results are reported between 0% (bedridden) and 100% (healthy). Negative changes in values indicate a decline in health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Serum Concentration (Cmax) for ABBV-8E12</measure>
    <time_frame>First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113</time_frame>
    <description>The maximum observed serum concentration after the first and the fifth doses in Cohort 1 and Cohort J1 was determined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Maximum Observed Serum Concentration (Tmax) for ABBV-8E12</measure>
    <time_frame>First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113</time_frame>
    <description>The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax, the maximum plasma concentration. Tmax was measured after the first and the fifth doses in Cohort 1 and Cohort J1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration Time Curve (AUC) for ABBV-8E12</measure>
    <time_frame>First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113</time_frame>
    <description>The area under the plasma concentration-time curve (AUC; measured in µg•day/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABBV-8E12 was estimated using non-compartmental methods after the first and the fifth doses in Cohort 1 and Cohort J1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Concentration of ABBV-8E12 Prior to Infusion of a Day of Dosing (Ctrough)</measure>
    <time_frame>First day of the Fifth Dosing Interval, Day 85</time_frame>
    <description>The concentration of ABBV-8E12 immediately prior to infusion of the fifth dose (Ctrough; measured in µg/mL) was estimated using non-compartmental methods in Cohort 1 and Cohort J1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to Week 52 in Clinical Global Impression of Severity (CGI-S) Score</measure>
    <time_frame>Baseline, Week 52</time_frame>
    <description>The CGI-S is a clinician's rating of disease severity. The CGI-S rates severity of illness on a 7-point scale, using a range of responses from 1 (normal) through 7 (the most severely ill). This rating is based upon observed and reported symptoms, behavior, and function in the past 7 days. Positive changes in score indicate worsening from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Health Related Quality of Life Scale (PSP-QoL) Total Score</measure>
    <time_frame>Baseline, Week 52</time_frame>
    <description>The PSP-QoL is a validated patient-reported outcome measure, specifically designed to assess the quality of life of participants with PSP. There are 45 items and two subscales: physical and mental impact. Items are scored from 0 (no problem) to 4 (extreme problems). The total subscale sum scores are linearly converted into a 0 to 100 scale, and higher scores indicate a lower quality of life. Positive changes in score indicate a decline in quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Staging System Score (PSP-SS) Score</measure>
    <time_frame>Baseline, Week 52</time_frame>
    <description>The Progressive Supranuclear Palsy Rating Scale (PSPRS) consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for four items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. The PSP-SS score is a composite of the dysphagia and gait items from the PSPRS. Positive changes in score indicate worsening from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to Week 52 in Third Ventricle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)</measure>
    <time_frame>Baseline, Week 52</time_frame>
    <description>Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify third ventricle atrophy. Positive changes in values indicate an increase in volume.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to Week 52 in Superior Cerebellar Peduncle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)</measure>
    <time_frame>Baseline, Week 52</time_frame>
    <description>Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify Superior cerebellar peduncle atrophy. Negative changes in values indicate a reduction in volume.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to Week 52 in Brainstem Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)</measure>
    <time_frame>Baseline, Week 52</time_frame>
    <description>Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify brainstem atrophy. Negative changes in values indicate a reduction in volume.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to Week 52 in Whole Brain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)</measure>
    <time_frame>Baseline, Week 52</time_frame>
    <description>Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify whole brain atrophy. Negative changes in values indicate a reduction in volume.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline to Week 52 in Frontal Lobe Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)</measure>
    <time_frame>Baseline, Week 52</time_frame>
    <description>Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify frontal lobe atrophy. Positive changes in values indicate an increase in volume.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Loss of Ability to Walk Independently as Measured by Progressive Supranuclear Palsy Rating Scale (PSPRS) Item 26</measure>
    <time_frame>From Baseline to Week 52</time_frame>
    <description>The PSPRS consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for six items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Item 26 pertains to gait, scored as either 0 (normal); 1 (slightly wide-based or irregular or slight pulsion on turns); 2 (must walk slowly or occasionally use walls or helper to avoid falling, especially on turns); 3 (must use assistance all or almost all the time); or 4 (unable to walk, even with walker; may be able to transfer).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">378</enrollment>
  <condition>Progressive Supranuclear Palsy</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABBV-8E12 2000 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABBV-8E12 4000 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW &gt;59 kg, 4.7 mL/min or 282 mL/hr.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABBV-8E12</intervention_name>
    <description>Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW &gt;59 kg, 4.7 mL/min or 282 mL/hr. For participants in Cohort 2, ABBV-8E12 doses may have been decreased after the evaluation by the Data Monitoring Committee of available safety, tolerability and pharmacokinetic data.</description>
    <arm_group_label>ABBV-8E12 2000 mg</arm_group_label>
    <arm_group_label>ABBV-8E12 4000 mg</arm_group_label>
    <other_name>Tilavonemab</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Male or female participant with age 40 years or greater at the time of signed consent&#xD;
&#xD;
          -  Meets the criteria for possible or probable progressive supranuclear palsy (PSP;&#xD;
             Steele-Richardson-Olszewski Syndrome)&#xD;
&#xD;
          -  Presence of PSP symptoms for less than 5 years&#xD;
&#xD;
          -  Participant is able to walk 5 steps with minimal assistance (stabilization of one arm&#xD;
             or use of cane/walker)&#xD;
&#xD;
          -  Participant has an identified, reliable, study partner (e.g., caregiver, family&#xD;
             member, social worker, or friend)&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Participants who weigh less than 44 kg (97 lbs) at screening&#xD;
&#xD;
          -  Mini-Mental State Examination (MMSE) score less than 15 at screening&#xD;
&#xD;
          -  Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)&#xD;
&#xD;
          -  Participant resides at a skilled nursing or dementia care facility, or admission to&#xD;
             such a facility is planned during the study period&#xD;
&#xD;
          -  Evidence of any clinically significant neurological disorder other than PSP&#xD;
&#xD;
          -  The participant has a history of or currently has schizophrenia, schizoaffective&#xD;
             disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental&#xD;
             Disorders, 5th Edition (DSM-V) or International Classification of Diseases (ICD-10)&#xD;
             criteria&#xD;
&#xD;
          -  Participant has had a significant illness or infection requiring medical intervention&#xD;
             in the past 30 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AbbVie Inc.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham - Main /ID# 144892</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic - Scottsdale /ID# 144893</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center /ID# 149775</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ucsd /Id# 144905</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Usc /Id# 149773</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, Los Angeles /ID# 144896</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ California, San Francisco /ID# 144897</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143-2204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Movement Disorders Center /ID# 153397</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113-2736</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida - Archer /ID# 144906</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic /ID# 144911</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida /ID# 144912</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Regents University /ID# 144908</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center /ID# 144894</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago /ID# 148672</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637-1443</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University /ID# 149036</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky Chandler Medical Center /ID# 144891</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic - Rochester /ID# 144895</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905-0001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Hosp. of Kansas Cit /ID# 168629</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Lou Ruvo Cent /ID# 148919</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers Robert Wood Johnson /ID# 144901</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>COLUMBIA University Medical Center /ID# 149037</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032-3725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Main Campus /ID# 144885</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University /ID# 149774</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt Univ Med Ctr /ID# 144898</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232-0011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kerwin Research Center /ID# 144904</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231-4316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGovern Medical School /ID# 149236</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Texas Neurology Consul /ID# 167417</name>
      <address>
        <city>Round Rock</city>
        <state>Texas</state>
        <zip>78681</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital /ID# 154403</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Q-Pharm Pty Limited /ID# 154410</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4006</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital /ID# 153157</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alfred Hospital /ID# 153158</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurodegenerative Disorders Re /ID# 153770</name>
      <address>
        <city>West Perth</city>
        <state>Western Australia</state>
        <zip>6005</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Calgary /ID# 154393</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4Z6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OCT Research ULC /ID# 169688</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y 1Z9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Western Hospital /ID# 152818</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Crchum /Id# 152819</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 0A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal Neurological Institut /ID# 156413</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3A 2B4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Universitaire Purpan /ID# 153152</name>
      <address>
        <city>Toulouse</city>
        <state>Haute-Garonne</state>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de la Timone /ID# 153113</name>
      <address>
        <city>Marseille CEDEX 05</city>
        <state>Provence-Alpes-Cote-d Azur</state>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu de Bordeaux Hopital /Id# 153151</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital B Roger Salengro /ID# 153943</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Pitie Salpetriere /ID# 153942</name>
      <address>
        <city>Paris</city>
        <zip>75651</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Strasbourg Hautepierre Hos /ID# 206942</name>
      <address>
        <city>Strasbourg</city>
        <zip>67200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Josef-Hospital /ID# 201984</name>
      <address>
        <city>Bochum</city>
        <state>Nordrhein-Westfalen</state>
        <zip>44791</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Leipzig /ID# 201761</name>
      <address>
        <city>Leipzig</city>
        <state>Sachsen</state>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Ulm /ID# 153155</name>
      <address>
        <city>Ulm</city>
        <state>Thueringen</state>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KH Agatharied /ID# 154166</name>
      <address>
        <city>Hausham</city>
        <zip>83734</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TU Uniklinik Munchen /ID# 153154</name>
      <address>
        <city>Munich</city>
        <zip>80802</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita di Catanzaro Magna Graecia /ID# 166322</name>
      <address>
        <city>Catanzaro</city>
        <state>Calabria</state>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Agostino Gemelli /ID# 153104</name>
      <address>
        <city>Rome</city>
        <state>Lazio</state>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IBD Center - IRCCS Istituto Clinico Humanitas /ID# 155092</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 201982</name>
      <address>
        <city>Milan</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Neuro Mediterraneo IR /ID# 153106</name>
      <address>
        <city>Pozzilli</city>
        <zip>86077</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Santa Maria /ID# 153102</name>
      <address>
        <city>Terni</city>
        <zip>05100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Ospedale San Camillo /ID# 153101</name>
      <address>
        <city>Venezia LIDO</city>
        <zip>30126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Higashinagoya National Hospital /ID# 201514</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>4658620</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Asahikawa Medical Center /ID# 201585</name>
      <address>
        <city>Asahikawa</city>
        <state>Hokkaido</state>
        <zip>070-8644</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Utano National Hospital /ID# 201979</name>
      <address>
        <city>Kyoto City</city>
        <state>Kyoto</state>
        <zip>616-8255</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital /ID# 202307</name>
      <address>
        <city>Sendai-shi</city>
        <state>Miyagi</state>
        <zip>980-8574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHO Sendai Nishitaga National Hospital /ID# 202132</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <zip>982-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niigata University Medical &amp; Dental Hospital /ID# 201680</name>
      <address>
        <city>Niigata-shi</city>
        <state>Niigata</state>
        <zip>951-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka University Hospital /ID# 201980</name>
      <address>
        <city>Suita-shi</city>
        <state>Osaka</state>
        <zip>565-0871</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juntendo University Hospital /ID# 200870</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-8431</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Center of Neurology and Psychiatry /ID# 202037</name>
      <address>
        <city>Kodaira</city>
        <state>Tokyo</state>
        <zip>187-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Maranon /ID# 200876</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp Univ Virgen del Rocio /ID# 201039</name>
      <address>
        <city>Sevilla</city>
        <zip>41001</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <results_first_submitted>November 2, 2020</results_first_submitted>
  <results_first_submitted_qc>February 1, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 3, 2021</results_first_posted>
  <last_update_submitted>February 1, 2021</last_update_submitted>
  <last_update_submitted_qc>February 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PSP</keyword>
  <keyword>Steele-Richardson-Olszewski syndrome</keyword>
  <keyword>Tauopathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Supranuclear Palsy, Progressive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tilavonemab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.</ipd_time_frame>
    <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.</ipd_access_criteria>
    <ipd_url>https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT02985879/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>October 23, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT02985879/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>All randomized participants; one participant in the ABBV-8E12 2000 mg dose group never received study drug</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks</description>
        </group>
        <group group_id="P2">
          <title>ABBV-8E12 2000mg</title>
          <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
        </group>
        <group group_id="P3">
          <title>ABBV-8E12 4000mg</title>
          <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="126"/>
                <participants group_id="P2" count="127"/>
                <participants group_id="P3" count="125"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="52"/>
                <participants group_id="P3" count="48"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="76"/>
                <participants group_id="P2" count="75"/>
                <participants group_id="P3" count="77"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other, not specified</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="58"/>
                <participants group_id="P3" count="58"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety dataset: all randomized participants who received at least one dose of study drug</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks</description>
        </group>
        <group group_id="B2">
          <title>ABBV-8E12 2000mg</title>
          <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
        </group>
        <group group_id="B3">
          <title>ABBV-8E12 4000mg</title>
          <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="126"/>
            <count group_id="B2" value="126"/>
            <count group_id="B3" value="125"/>
            <count group_id="B4" value="377"/>
          </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="68.1" spread="6.22"/>
                    <measurement group_id="B2" value="68.3" spread="7.25"/>
                    <measurement group_id="B3" value="70.0" spread="6.85"/>
                    <measurement group_id="B4" value="68.8" spread="6.82"/>
                  </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="53"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="56"/>
                    <measurement group_id="B4" value="158"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="69"/>
                    <measurement group_id="B4" value="219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                    <measurement group_id="B2" value="106"/>
                    <measurement group_id="B3" value="109"/>
                    <measurement group_id="B4" value="324"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multiple</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Week 52 in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score</title>
        <description>The PSPRS consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for six items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Positive changes in score indicate worsening from baseline.</description>
        <time_frame>Baseline, Week 52</time_frame>
        <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABBV-8E12 2000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
          <group group_id="O3">
            <title>ABBV-8E12 4000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 52 in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score</title>
          <description>The PSPRS consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for six items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Positive changes in score indicate worsening from baseline.</description>
          <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5" spread="0.94"/>
                    <measurement group_id="O2" value="10.5" spread="0.96"/>
                    <measurement group_id="O3" value="11.4" spread="0.94"/>
                  </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>
            <groups_desc>ABBV-8E12 2000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.998</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.34</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.63</ci_lower_limit>
            <ci_upper_limit>2.63</ci_upper_limit>
            <estimate_desc>ABBV-8E12 2000 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ABBV-8E12 4000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.464</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>1.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.32</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.63</ci_lower_limit>
            <ci_upper_limit>3.58</ci_upper_limit>
            <estimate_desc>ABBV-8E12 4000 mg - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events</title>
        <description>An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity from first dose of study drug until 20 weeks after the last dose. For more details on AEs please see the Adverse Event section.</description>
        <time_frame>From the first dose of study drug until 20 weeks following discontinuation of study drug administration have elapsed (approximately 5 half-lives), up to 80 weeks</time_frame>
        <population>Safety Dataset: all randomized participants who received at least one dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABBV-8E12 2000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
          <group group_id="O3">
            <title>ABBV-8E12 4000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <description>An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity from first dose of study drug until 20 weeks after the last dose. For more details on AEs please see the Adverse Event section.</description>
          <population>Safety Dataset: all randomized participants who received at least one dose of study drug</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="126"/>
                <count group_id="O2" value="126"/>
                <count group_id="O3" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108"/>
                    <measurement group_id="O2" value="111"/>
                    <measurement group_id="O3" value="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)</title>
        <description>The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions related to Activities of Daily Living, and ranges from 0-52. Higher scores are associated with more disability. Positive changes in score indicate worsening from baseline.</description>
        <time_frame>Baseline, Week 52</time_frame>
        <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABBV-8E12 2000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
          <group group_id="O3">
            <title>ABBV-8E12 4000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)</title>
          <description>The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions related to Activities of Daily Living, and ranges from 0-52. Higher scores are associated with more disability. Positive changes in score indicate worsening from baseline.</description>
          <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" spread="0.62"/>
                    <measurement group_id="O2" value="5.8" spread="0.63"/>
                    <measurement group_id="O3" value="7.0" spread="0.63"/>
                  </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>
            <groups_desc>ABBV-8E12 2000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.812</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.88</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.52</ci_lower_limit>
            <ci_upper_limit>1.93</ci_upper_limit>
            <estimate_desc>ABBV-8E12 2000 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ABBV-8E12 4000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.104</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>1.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.88</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.30</ci_lower_limit>
            <ci_upper_limit>3.16</ci_upper_limit>
            <estimate_desc>ABBV-8E12 4000 mg - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Global Impression of Change (CGI-C) Score at Week 52</title>
        <description>The Clinical Global Impression of Change (CGI-C) score is a clinician's rating scale for assessing Global Improvement of Change. The CGI-C rates improvement by 7 categories: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), very much worse (7). The CGI-C score ranges from 1 to 7, with lower scores indicating improvement.</description>
        <time_frame>Week 52</time_frame>
        <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at Week 52</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABBV-8E12 2000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
          <group group_id="O3">
            <title>ABBV-8E12 4000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Global Impression of Change (CGI-C) Score at Week 52</title>
          <description>The Clinical Global Impression of Change (CGI-C) score is a clinician's rating scale for assessing Global Improvement of Change. The CGI-C rates improvement by 7 categories: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), very much worse (7). The CGI-C score ranges from 1 to 7, with lower scores indicating improvement.</description>
          <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at Week 52</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" spread="0.11"/>
                    <measurement group_id="O2" value="5.1" spread="0.11"/>
                    <measurement group_id="O3" value="5.0" spread="0.11"/>
                  </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>
            <groups_desc>ABBV-8E12 2000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.756</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.16</dispersion_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>0.26</ci_upper_limit>
            <estimate_desc>ABBV-8E12 2000 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ABBV-8E12 4000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.409</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.16</dispersion_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>0.18</ci_upper_limit>
            <estimate_desc>ABBV-8E12 4000 mg - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to Week 52 in Midbrain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)</title>
        <description>Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify midbrain atrophy. Negative changes in values indicate a reduction in volume.</description>
        <time_frame>Baseline, Week 52</time_frame>
        <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABBV-8E12 2000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
          <group group_id="O3">
            <title>ABBV-8E12 4000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to Week 52 in Midbrain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)</title>
          <description>Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify midbrain atrophy. Negative changes in values indicate a reduction in volume.</description>
          <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
          <units>mm^3</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-122.0" spread="9.64"/>
                    <measurement group_id="O2" value="-129.1" spread="9.69"/>
                    <measurement group_id="O3" value="-128.3" spread="9.69"/>
                  </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>
            <groups_desc>ABBV-8E12 2000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.597</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-7.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>13.54</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.86</ci_lower_limit>
            <ci_upper_limit>19.53</ci_upper_limit>
            <estimate_desc>ABBV-8E12 2000 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ABBV-8E12 4000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.642</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-6.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>13.56</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.04</ci_lower_limit>
            <ci_upper_limit>20.42</ci_upper_limit>
            <estimate_desc>ABBV-8E12 4000 mg - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL)</title>
        <description>The Schwab and England Activities of Daily Living (SEADL) consists of ten items intended to evaluate the daily life activities of a participant. The SEADL is composed of two sections: the first is a self-reported questionnaire in which participants grade their own daily life activities, such as dressing, using the toilet, resting, eating, and social activities (subjective assessment), and the second is an assessment of motor functions, such as postural balance, speaking, rigidity, and tremors, conducted by a clinician (objective assessment). It is a percentage scale divided into deciles, and the results are reported between 0% (bedridden) and 100% (healthy). Negative changes in values indicate a decline in health.</description>
        <time_frame>Baseline, Week 52</time_frame>
        <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABBV-8E12 2000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
          <group group_id="O3">
            <title>ABBV-8E12 4000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL)</title>
          <description>The Schwab and England Activities of Daily Living (SEADL) consists of ten items intended to evaluate the daily life activities of a participant. The SEADL is composed of two sections: the first is a self-reported questionnaire in which participants grade their own daily life activities, such as dressing, using the toilet, resting, eating, and social activities (subjective assessment), and the second is an assessment of motor functions, such as postural balance, speaking, rigidity, and tremors, conducted by a clinician (objective assessment). It is a percentage scale divided into deciles, and the results are reported between 0% (bedridden) and 100% (healthy). Negative changes in values indicate a decline in health.</description>
          <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
          <units>percentage of independence</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.6" spread="1.79"/>
                    <measurement group_id="O2" value="-18.0" spread="1.82"/>
                    <measurement group_id="O3" value="-20.5" spread="1.77"/>
                  </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>
            <groups_desc>ABBV-8E12 2000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.323</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>2.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.53</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.48</ci_lower_limit>
            <ci_upper_limit>7.51</ci_upper_limit>
            <estimate_desc>ABBV-8E12 2000 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ABBV-8E12 4000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.974</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.51</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.86</ci_lower_limit>
            <ci_upper_limit>5.02</ci_upper_limit>
            <estimate_desc>ABBV-8E12 4000 mg - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Serum Concentration (Cmax) for ABBV-8E12</title>
        <description>The maximum observed serum concentration after the first and the fifth doses in Cohort 1 and Cohort J1 was determined.</description>
        <time_frame>First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113</time_frame>
        <population>Participants in Cohort 1 and Cohort J1 with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, ABBV-8E12 2000 mg</title>
            <description>First 30 participants enrolled into the global study from countries other than Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 2000 mg</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1, ABBV-8E12 4000 mg</title>
            <description>First 30 participants enrolled into the global study from countries other than Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 4000 mg</description>
          </group>
          <group group_id="O3">
            <title>Cohort J1, ABBV-8E12 2000 mg</title>
            <description>First 9 participants enrolled into the study from Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 2000 mg</description>
          </group>
          <group group_id="O4">
            <title>Cohort J1, ABBV-8E12 4000 mg</title>
            <description>First 9 participants enrolled into the study from Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 4000 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Serum Concentration (Cmax) for ABBV-8E12</title>
          <description>The maximum observed serum concentration after the first and the fifth doses in Cohort 1 and Cohort J1 was determined.</description>
          <population>Participants in Cohort 1 and Cohort J1 with available data</population>
          <units>µg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>First Dosing Interval, 2 weeks, Day 1-14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="714" spread="32"/>
                    <measurement group_id="O2" value="1450" spread="20"/>
                    <measurement group_id="O3" value="853" spread="6"/>
                    <measurement group_id="O4" value="1580" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fifth Dosing Interval, 4 weeks, Day 85-113</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1070" spread="56"/>
                    <measurement group_id="O2" value="2350" spread="23"/>
                    <measurement group_id="O3" value="1010" spread="21"/>
                    <measurement group_id="O4" value="1960" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Maximum Observed Serum Concentration (Tmax) for ABBV-8E12</title>
        <description>The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax, the maximum plasma concentration. Tmax was measured after the first and the fifth doses in Cohort 1 and Cohort J1.</description>
        <time_frame>First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113</time_frame>
        <population>Participants in Cohort 1 and Cohort J1 with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, ABBV-8E12 2000 mg</title>
            <description>First 30 participants enrolled into the global study from countries other than Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 2000 mg</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1, ABBV-8E12 4000 mg</title>
            <description>First 30 participants enrolled into the global study from countries other than Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 4000 mg</description>
          </group>
          <group group_id="O3">
            <title>Cohort J1, ABBV-8E12 2000 mg</title>
            <description>First 9 participants enrolled into the study from Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 2000 mg</description>
          </group>
          <group group_id="O4">
            <title>Cohort J1, ABBV-8E12 4000 mg</title>
            <description>First 9 participants enrolled into the study from Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 4000 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Maximum Observed Serum Concentration (Tmax) for ABBV-8E12</title>
          <description>The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax, the maximum plasma concentration. Tmax was measured after the first and the fifth doses in Cohort 1 and Cohort J1.</description>
          <population>Participants in Cohort 1 and Cohort J1 with available data</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>First Dosing Interval, 2 weeks, Day 1-14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="3.2" upper_limit="6.1"/>
                    <measurement group_id="O2" value="4.1" lower_limit="3.2" upper_limit="5.6"/>
                    <measurement group_id="O3" value="5.0" lower_limit="4.0" upper_limit="5.2"/>
                    <measurement group_id="O4" value="4.8" lower_limit="4.3" upper_limit="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fifth Dosing Interval, 4 weeks, Day 85-113</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" lower_limit="2.9" upper_limit="5.5"/>
                    <measurement group_id="O2" value="4.0" lower_limit="3.3" upper_limit="46.2"/>
                    <measurement group_id="O3" value="5.0" lower_limit="4.4" upper_limit="5.7"/>
                    <measurement group_id="O4" value="3.4" lower_limit="3.2" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration Time Curve (AUC) for ABBV-8E12</title>
        <description>The area under the plasma concentration-time curve (AUC; measured in µg•day/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABBV-8E12 was estimated using non-compartmental methods after the first and the fifth doses in Cohort 1 and Cohort J1.</description>
        <time_frame>First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113</time_frame>
        <population>Participants in Cohort 1 and Cohort J1 with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, ABBV-8E12 2000 mg</title>
            <description>First 30 participants enrolled into the global study from countries other than Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 2000 mg</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1, ABBV-8E12 4000 mg</title>
            <description>First 30 participants enrolled into the global study from countries other than Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 4000 mg</description>
          </group>
          <group group_id="O3">
            <title>Cohort J1, ABBV-8E12 2000 mg</title>
            <description>First 9 participants enrolled into the study from Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 2000 mg</description>
          </group>
          <group group_id="O4">
            <title>Cohort J1, ABBV-8E12 4000 mg</title>
            <description>First 9 participants enrolled into the study from Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 4000 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration Time Curve (AUC) for ABBV-8E12</title>
          <description>The area under the plasma concentration-time curve (AUC; measured in µg•day/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABBV-8E12 was estimated using non-compartmental methods after the first and the fifth doses in Cohort 1 and Cohort J1.</description>
          <population>Participants in Cohort 1 and Cohort J1 with available data</population>
          <units>µg•day/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>First Dosing Interval, 2 weeks, Day 1-14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5070" spread="25"/>
                    <measurement group_id="O2" value="10400" spread="21"/>
                    <measurement group_id="O3" value="5950" spread="12"/>
                    <measurement group_id="O4" value="10400" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fifth Dosing Interval, 4 weeks, Day 85-113</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13900" spread="28"/>
                    <measurement group_id="O2" value="31600" spread="36"/>
                    <measurement group_id="O3" value="15200" spread="21"/>
                    <measurement group_id="O4" value="23900" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Concentration of ABBV-8E12 Prior to Infusion of a Day of Dosing (Ctrough)</title>
        <description>The concentration of ABBV-8E12 immediately prior to infusion of the fifth dose (Ctrough; measured in µg/mL) was estimated using non-compartmental methods in Cohort 1 and Cohort J1.</description>
        <time_frame>First day of the Fifth Dosing Interval, Day 85</time_frame>
        <population>Participants in Cohort 1 and Cohort J1 with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1, ABBV-8E12 2000 mg</title>
            <description>First 30 participants enrolled into the global study from countries other than Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 2000 mg</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1, ABBV-8E12 4000 mg</title>
            <description>First 30 participants enrolled into the global study from countries other than Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 4000 mg</description>
          </group>
          <group group_id="O3">
            <title>Cohort J1, ABBV-8E12 2000 mg</title>
            <description>First 9 participants enrolled into the study from Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 2000 mg</description>
          </group>
          <group group_id="O4">
            <title>Cohort J1, ABBV-8E12 4000 mg</title>
            <description>First 9 participants enrolled into the study from Japan who received augmented safety and PK assessments and ABBV-8E12 at a dose of 4000 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Concentration of ABBV-8E12 Prior to Infusion of a Day of Dosing (Ctrough)</title>
          <description>The concentration of ABBV-8E12 immediately prior to infusion of the fifth dose (Ctrough; measured in µg/mL) was estimated using non-compartmental methods in Cohort 1 and Cohort J1.</description>
          <population>Participants in Cohort 1 and Cohort J1 with available data</population>
          <units>µg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="353" spread="27"/>
                    <measurement group_id="O2" value="657" spread="45"/>
                    <measurement group_id="O3" value="345" spread="32"/>
                    <measurement group_id="O4" value="595" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to Week 52 in Clinical Global Impression of Severity (CGI-S) Score</title>
        <description>The CGI-S is a clinician's rating of disease severity. The CGI-S rates severity of illness on a 7-point scale, using a range of responses from 1 (normal) through 7 (the most severely ill). This rating is based upon observed and reported symptoms, behavior, and function in the past 7 days. Positive changes in score indicate worsening from baseline.</description>
        <time_frame>Baseline, Week 52</time_frame>
        <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABBV-8E12 2000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
          <group group_id="O3">
            <title>ABBV-8E12 4000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to Week 52 in Clinical Global Impression of Severity (CGI-S) Score</title>
          <description>The CGI-S is a clinician's rating of disease severity. The CGI-S rates severity of illness on a 7-point scale, using a range of responses from 1 (normal) through 7 (the most severely ill). This rating is based upon observed and reported symptoms, behavior, and function in the past 7 days. Positive changes in score indicate worsening from baseline.</description>
          <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.10"/>
                    <measurement group_id="O2" value="0.6" spread="0.10"/>
                    <measurement group_id="O3" value="0.6" spread="0.10"/>
                  </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>
            <groups_desc>ABBV-8E12 2000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.761</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_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>0.23</ci_upper_limit>
            <estimate_desc>ABBV-8E12 2000 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ABBV-8E12 4000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.678</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.32</ci_lower_limit>
            <ci_upper_limit>0.21</ci_upper_limit>
            <estimate_desc>ABBV-8E12 4000 mg - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Health Related Quality of Life Scale (PSP-QoL) Total Score</title>
        <description>The PSP-QoL is a validated patient-reported outcome measure, specifically designed to assess the quality of life of participants with PSP. There are 45 items and two subscales: physical and mental impact. Items are scored from 0 (no problem) to 4 (extreme problems). The total subscale sum scores are linearly converted into a 0 to 100 scale, and higher scores indicate a lower quality of life. Positive changes in score indicate a decline in quality of life.</description>
        <time_frame>Baseline, Week 52</time_frame>
        <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABBV-8E12 2000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
          <group group_id="O3">
            <title>ABBV-8E12 4000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Health Related Quality of Life Scale (PSP-QoL) Total Score</title>
          <description>The PSP-QoL is a validated patient-reported outcome measure, specifically designed to assess the quality of life of participants with PSP. There are 45 items and two subscales: physical and mental impact. Items are scored from 0 (no problem) to 4 (extreme problems). The total subscale sum scores are linearly converted into a 0 to 100 scale, and higher scores indicate a lower quality of life. Positive changes in score indicate a decline in quality of life.</description>
          <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2" spread="1.63"/>
                    <measurement group_id="O2" value="10.3" spread="1.65"/>
                    <measurement group_id="O3" value="10.0" spread="1.64"/>
                  </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>
            <groups_desc>ABBV-8E12 2000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.653</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>1.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.30</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.50</ci_lower_limit>
            <ci_upper_limit>5.57</ci_upper_limit>
            <estimate_desc>ABBV-8E12 2000 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ABBV-8E12 4000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.748</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>1.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.30</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.50</ci_lower_limit>
            <ci_upper_limit>5.57</ci_upper_limit>
            <estimate_desc>ABBV-8E12 4000 mg - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Staging System Score (PSP-SS) Score</title>
        <description>The Progressive Supranuclear Palsy Rating Scale (PSPRS) consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for four items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. The PSP-SS score is a composite of the dysphagia and gait items from the PSPRS. Positive changes in score indicate worsening from baseline.</description>
        <time_frame>Baseline, Week 52</time_frame>
        <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABBV-8E12 2000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
          <group group_id="O3">
            <title>ABBV-8E12 4000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Staging System Score (PSP-SS) Score</title>
          <description>The Progressive Supranuclear Palsy Rating Scale (PSPRS) consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for four items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. The PSP-SS score is a composite of the dysphagia and gait items from the PSPRS. Positive changes in score indicate worsening from baseline.</description>
          <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.24"/>
                    <measurement group_id="O2" value="0.9" spread="0.24"/>
                    <measurement group_id="O3" value="1.0" spread="0.24"/>
                  </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>
            <groups_desc>ABBV-8E12 2000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.828</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.34</dispersion_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>0.74</ci_upper_limit>
            <estimate_desc>ABBV-8E12 2000 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ABBV-8E12 4000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.543</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.34</dispersion_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>0.87</ci_upper_limit>
            <estimate_desc>ABBV-8E12 4000 mg - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to Week 52 in Third Ventricle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)</title>
        <description>Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify third ventricle atrophy. Positive changes in values indicate an increase in volume.</description>
        <time_frame>Baseline, Week 52</time_frame>
        <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABBV-8E12 2000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
          <group group_id="O3">
            <title>ABBV-8E12 4000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to Week 52 in Third Ventricle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)</title>
          <description>Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify third ventricle atrophy. Positive changes in values indicate an increase in volume.</description>
          <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
          <units>mm^3</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="58"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157.9" spread="18.27"/>
                    <measurement group_id="O2" value="152.4" spread="18.04"/>
                    <measurement group_id="O3" value="125.0" spread="18.57"/>
                  </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>
            <groups_desc>ABBV-8E12 2000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.829</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-5.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>25.44</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-55.66</ci_lower_limit>
            <ci_upper_limit>44.63</ci_upper_limit>
            <estimate_desc>ABBV-8E12 2000 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ABBV-8E12 4000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.206</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-32.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>25.92</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-83.94</ci_lower_limit>
            <ci_upper_limit>18.23</ci_upper_limit>
            <estimate_desc>ABBV-8E12 4000 mg - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to Week 52 in Superior Cerebellar Peduncle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)</title>
        <description>Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify Superior cerebellar peduncle atrophy. Negative changes in values indicate a reduction in volume.</description>
        <time_frame>Baseline, Week 52</time_frame>
        <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABBV-8E12 2000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
          <group group_id="O3">
            <title>ABBV-8E12 4000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to Week 52 in Superior Cerebellar Peduncle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)</title>
          <description>Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify Superior cerebellar peduncle atrophy. Negative changes in values indicate a reduction in volume.</description>
          <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
          <units>mm^3</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.3" spread="2.78"/>
                    <measurement group_id="O2" value="-4.3" spread="2.74"/>
                    <measurement group_id="O3" value="-3.7" spread="2.74"/>
                  </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>
            <groups_desc>ABBV-8E12 2000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.304</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>4.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.88</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.65</ci_lower_limit>
            <ci_upper_limit>11.65</ci_upper_limit>
            <estimate_desc>ABBV-8E12 2000 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ABBV-8E12 4000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.243</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>4.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.88</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.11</ci_lower_limit>
            <ci_upper_limit>12.19</ci_upper_limit>
            <estimate_desc>ABBV-8E12 4000 mg - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to Week 52 in Brainstem Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)</title>
        <description>Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify brainstem atrophy. Negative changes in values indicate a reduction in volume.</description>
        <time_frame>Baseline, Week 52</time_frame>
        <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABBV-8E12 2000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
          <group group_id="O3">
            <title>ABBV-8E12 4000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to Week 52 in Brainstem Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)</title>
          <description>Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify brainstem atrophy. Negative changes in values indicate a reduction in volume.</description>
          <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
          <units>mm^3</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-374.5" spread="38.42"/>
                    <measurement group_id="O2" value="-400.9" spread="38.60"/>
                    <measurement group_id="O3" value="-341.3" spread="40.61"/>
                  </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>
            <groups_desc>ABBV-8E12 2000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>0.625</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-26.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>53.86</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-132.76</ci_lower_limit>
            <ci_upper_limit>79.94</ci_upper_limit>
            <estimate_desc>ABBV-8E12 2000 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ABBV-8E12 4000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.550</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>33.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>55.47</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-76.34</ci_lower_limit>
            <ci_upper_limit>142.71</ci_upper_limit>
            <estimate_desc>ABBV-8E12 4000 mg - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to Week 52 in Whole Brain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)</title>
        <description>Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify whole brain atrophy. Negative changes in values indicate a reduction in volume.</description>
        <time_frame>Baseline, Week 52</time_frame>
        <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABBV-8E12 2000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
          <group group_id="O3">
            <title>ABBV-8E12 4000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to Week 52 in Whole Brain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)</title>
          <description>Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify whole brain atrophy. Negative changes in values indicate a reduction in volume.</description>
          <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
          <units>mm^3</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22496.2" spread="1793.36"/>
                    <measurement group_id="O2" value="-20757.1" spread="1783.00"/>
                    <measurement group_id="O3" value="-18811.3" spread="1740.72"/>
                  </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>
            <groups_desc>ABBV-8E12 2000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.488</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>1739.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2502.95</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3201.75</ci_lower_limit>
            <ci_upper_limit>6680.02</ci_upper_limit>
            <estimate_desc>ABBV-8E12 2000 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ABBV-8E12 4000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.140</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>3684.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2487.32</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1225.46</ci_lower_limit>
            <ci_upper_limit>8595.29</ci_upper_limit>
            <estimate_desc>ABBV-8E12 4000 mg - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline to Week 52 in Frontal Lobe Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)</title>
        <description>Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify frontal lobe atrophy. Positive changes in values indicate an increase in volume.</description>
        <time_frame>Baseline, Week 52</time_frame>
        <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABBV-8E12 2000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
          <group group_id="O3">
            <title>ABBV-8E12 4000mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline to Week 52 in Frontal Lobe Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)</title>
          <description>Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify frontal lobe atrophy. Positive changes in values indicate an increase in volume.</description>
          <population>ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52</population>
          <units>mm^3</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1052.6" spread="425.55"/>
                    <measurement group_id="O2" value="1260.5" spread="423.96"/>
                    <measurement group_id="O3" value="1186.1" spread="445.18"/>
                  </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>
            <groups_desc>ABBV-8E12 2000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.726</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>207.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>592.68</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-962.98</ci_lower_limit>
            <ci_upper_limit>1378.88</ci_upper_limit>
            <estimate_desc>ABBV-8E12 2000 mg - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>ABBV-8E12 4000 mg vs Placebo</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.</non_inferiority_desc>
            <p_value>=0.828</p_value>
            <method>Mixed-effects model, repeated measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>133.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>611.91</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1075.26</ci_lower_limit>
            <ci_upper_limit>1342.40</ci_upper_limit>
            <estimate_desc>ABBV-8E12 4000 mg - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Loss of Ability to Walk Independently as Measured by Progressive Supranuclear Palsy Rating Scale (PSPRS) Item 26</title>
        <description>The PSPRS consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for six items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Item 26 pertains to gait, scored as either 0 (normal); 1 (slightly wide-based or irregular or slight pulsion on turns); 2 (must walk slowly or occasionally use walls or helper to avoid falling, especially on turns); 3 (must use assistance all or almost all the time); or 4 (unable to walk, even with walker; may be able to transfer).</description>
        <time_frame>From Baseline to Week 52</time_frame>
        <population>ITT dataset: all randomized participants who received at least one dose of study drug with available data</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABBV-8E12 2000 mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
          <group group_id="O3">
            <title>ABBV-8E12 4000 mg</title>
            <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Loss of Ability to Walk Independently as Measured by Progressive Supranuclear Palsy Rating Scale (PSPRS) Item 26</title>
          <description>The PSPRS consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for six items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Item 26 pertains to gait, scored as either 0 (normal); 1 (slightly wide-based or irregular or slight pulsion on turns); 2 (must walk slowly or occasionally use walls or helper to avoid falling, especially on turns); 3 (must use assistance all or almost all the time); or 4 (unable to walk, even with walker; may be able to transfer).</description>
          <population>ITT dataset: all randomized participants who received at least one dose of study drug with available data</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="126"/>
                <count group_id="O3" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169.0" lower_limit="89.0" upper_limit="255.0"/>
                    <measurement group_id="O2" value="170.0" lower_limit="87.0" upper_limit="253.0"/>
                    <measurement group_id="O3" value="203.0" lower_limit="169.0" upper_limit="255.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 20 weeks following discontinuation of study drug administration have elapsed (approximately 5 half-lives), up to 80 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.</time_frame>
      <desc>TEAEs and TESAEs are defined as any AE or TESAE with onset or worsening reported by a participant from the time that the first dose of study is administered until 20 weeks (approximately 5 half-lives) have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks</description>
        </group>
        <group group_id="E2">
          <title>ABBV-8E12 2000mg</title>
          <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
        </group>
        <group group_id="E3">
          <title>ABBV-8E12 4000mg</title>
          <description>Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 22.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="34" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>LEUKOCYTOSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE MYOCARDIAL INFARCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE CONGESTIVE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>CARDIO-RESPIRATORY ARREST</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>CARDIOPULMONARY FAILURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>CATARACT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>EYE SWELLING</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>OCULAR HYPERAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>COLITIS ISCHAEMIC</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>DYSPHAGIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>ENTEROVESICAL FISTULA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>GASTRIC PERFORATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL HYPERMOTILITY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>INTESTINAL OBSTRUCTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>PANCREATITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>DEATH</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>DISEASE PROGRESSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>GAIT DISTURBANCE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>GENERAL PHYSICAL HEALTH DETERIORATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>BILE DUCT STONE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>DRUG HYPERSENSITIVITY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>CELLULITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>CHOLECYSTITIS INFECTIVE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>CYSTITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>INFLUENZA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>ORCHITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>PNEUMONIA MYCOPLASMAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>SEPSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>BRAIN CONTUSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>CERVICAL VERTEBRAL FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>CLAVICLE FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>CONCUSSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>CONTUSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>FACIAL BONES FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>FALL</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="126"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="126"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>FEMORAL NECK FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>FEMUR FRACTURE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>FIBULA FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>FOREIGN BODY ASPIRATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>GUN SHOT WOUND</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>HEAD INJURY</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>HIP FRACTURE</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>HUMERUS FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>JOINT DISLOCATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>PERIPROSTHETIC FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>RADIUS FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>RIB FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>SKIN LACERATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>SKULL FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>SPINAL FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>SUBDURAL HAEMATOMA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>ULNA FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>UPPER LIMB FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>WRIST FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>RESIDUAL URINE VOLUME</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DEHYDRATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>HYPOGLYCAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>MALNUTRITION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>MUSCLE RIGIDITY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>MUSCULOSKELETAL CHEST PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>OSTEOARTHRITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>BREAST CANCER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>PROSTATE CANCER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>PROSTATE CANCER METASTATIC</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>APHASIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>BRAIN MIDLINE SHIFT</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>CARPAL TUNNEL SYNDROME</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>CEREBRAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>HEMIPARESIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>LOSS OF CONSCIOUSNESS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>PROGRESSIVE SUPRANUCLEAR PALSY</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>SEIZURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>SPINAL STROKE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>SUBDURAL HYGROMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>SYNCOPE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>COMPLETED SUICIDE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>DELIRIUM</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>MENTAL STATUS CHANGES</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>PSYCHOTIC DISORDER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>SUICIDAL IDEATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>SUICIDE ATTEMPT</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE KIDNEY INJURY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>BLADDER OBSTRUCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>DYSURIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>MICTURITION DISORDER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>NOCTURIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>URETEROLITHIASIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>URINARY RETENTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE RESPIRATORY DISTRESS SYNDROME</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>ASPIRATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>CHOKING</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>HYPOXIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>INTERSTITIAL LUNG DISEASE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>PNEUMONIA ASPIRATION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>PNEUMOTHORAX</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>PULMONARY EMBOLISM</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>RESPIRATORY ARREST</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>RESPIRATORY DISTRESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>RESPIRATORY FAILURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>DEEP VEIN THROMBOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 22.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="83" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="75" subjects_at_risk="126"/>
                <counts group_id="E3" subjects_affected="80" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="126"/>
                <counts group_id="E2" events="12" subjects_affected="9" subjects_at_risk="126"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="126"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="126"/>
                <counts group_id="E3" events="10" subjects_affected="8" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" events="9" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E2" events="19" subjects_affected="9" subjects_at_risk="126"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="126"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="126"/>
                <counts group_id="E3" events="9" subjects_affected="6" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="19" subjects_affected="14" subjects_at_risk="126"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="126"/>
                <counts group_id="E3" events="28" subjects_affected="18" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>CONTUSION</sub_title>
                <counts group_id="E1" events="23" subjects_affected="17" subjects_at_risk="126"/>
                <counts group_id="E2" events="20" subjects_affected="16" subjects_at_risk="126"/>
                <counts group_id="E3" events="30" subjects_affected="23" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>FALL</sub_title>
                <counts group_id="E1" events="96" subjects_affected="43" subjects_at_risk="126"/>
                <counts group_id="E2" events="70" subjects_affected="37" subjects_at_risk="126"/>
                <counts group_id="E3" events="85" subjects_affected="48" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>SKIN ABRASION</sub_title>
                <counts group_id="E1" events="27" subjects_affected="15" subjects_at_risk="126"/>
                <counts group_id="E2" events="16" subjects_affected="11" subjects_at_risk="126"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>SKIN LACERATION</sub_title>
                <counts group_id="E1" events="29" subjects_affected="19" subjects_at_risk="126"/>
                <counts group_id="E2" events="19" subjects_affected="17" subjects_at_risk="126"/>
                <counts group_id="E3" events="26" subjects_affected="21" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>WEIGHT DECREASED</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="126"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="126"/>
                <counts group_id="E3" events="15" subjects_affected="13" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>MUSCULOSKELETAL PAIN</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="126"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="126"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="126"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" events="13" subjects_affected="8" subjects_at_risk="126"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="126"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>ANXIETY</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="126"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="126"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>DEPRESSION</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="126"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="126"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="126"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="126"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="126"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="126"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>RASH</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="126"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="126"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Medical Services</name_or_title>
      <organization>AbbVie</organization>
      <phone>800-633-9110</phone>
      <email>abbvieclinicaltrials@abbvie.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/NCT02985879
org study id: M15-562
secondary id: 2016-001635-12
nct id: NCT02985879
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is us export: No
The purpose of this study was to assess efficacy, safety, tolerability, and pharmacokinetics
      of ABBV-8E12 in participants with progressive supranuclear palsy (PSP).
This was a Phase 2, randomized, double-blind, placebo-controlled, multiple dose, multicenter
      study consisting of a screening period of up to 8 weeks (56 days), a 52-week double-blind
      treatment period, and a post-treatment follow-up period of approximately 20 weeks following
      last study drug administration (for those participants who prematurely discontinued from
      treatment, declined to participate in or did not qualify for participation in a long term
      extension [LTE] study). At the end of the treatment period, extended treatment was available
      for eligible participants who completed the 52-week treatment period and entered the separate
      long-term extension study (NCT03391765; Study M15-563). There were 3 cohorts in the study
      (Cohort 1, Cohort J1, and Cohort 2). Cohort 1 had augmented safety and pharmacokinetic (PK)
      assessments in the first 30 participants enrolled into the global study from countries other
      than Japan. Cohort J1 had augmented safety and PK assessments in the first 9 participants
      enrolled into the study from Japan. Cohort 2 consisted of all other participants enrolled in
      the global study not participating in Cohort 1 or Cohort J1.

      This study was prematurely discontinued because the program for progressive supranuclear
      palsy was discontinued due to lack of efficacy of study drug.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline to Week 52 in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score
time frame: Baseline, Week 52
description: The PSPRS consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for six items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Positive changes in score indicate worsening from baseline.
measure: Number of Participants With Adverse Events
time frame: From the first dose of study drug until 20 weeks following discontinuation of study drug administration have elapsed (approximately 5 half-lives), up to 80 weeks
description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity from first dose of study drug until 20 weeks after the last dose. For more details on AEs please see the Adverse Event section.
measure: Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)
time frame: Baseline, Week 52
description: The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions related to Activities of Daily Living, and ranges from 0-52. Higher scores are associated with more disability. Positive changes in score indicate worsening from baseline.
measure: Clinical Global Impression of Change (CGI-C) Score at Week 52
time frame: Week 52
description: The Clinical Global Impression of Change (CGI-C) score is a clinician's rating scale for assessing Global Improvement of Change. The CGI-C rates improvement by 7 categories: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), very much worse (7). The CGI-C score ranges from 1 to 7, with lower scores indicating improvement.
measure: Mean Change From Baseline to Week 52 in Midbrain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
time frame: Baseline, Week 52
description: Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify midbrain atrophy. Negative changes in values indicate a reduction in volume.
measure: Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL)
time frame: Baseline, Week 52
description: The Schwab and England Activities of Daily Living (SEADL) consists of ten items intended to evaluate the daily life activities of a participant. The SEADL is composed of two sections: the first is a self-reported questionnaire in which participants grade their own daily life activities, such as dressing, using the toilet, resting, eating, and social activities (subjective assessment), and the second is an assessment of motor functions, such as postural balance, speaking, rigidity, and tremors, conducted by a clinician (objective assessment). It is a percentage scale divided into deciles, and the results are reported between 0% (bedridden) and 100% (healthy). Negative changes in values indicate a decline in health.
measure: Maximum Observed Serum Concentration (Cmax) for ABBV-8E12
time frame: First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113
description: The maximum observed serum concentration after the first and the fifth doses in Cohort 1 and Cohort J1 was determined.
measure: Time to Maximum Observed Serum Concentration (Tmax) for ABBV-8E12
time frame: First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113
description: The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax, the maximum plasma concentration. Tmax was measured after the first and the fifth doses in Cohort 1 and Cohort J1.
measure: Area Under the Concentration Time Curve (AUC) for ABBV-8E12
time frame: First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113
description: The area under the plasma concentration-time curve (AUC; measured in µg•day/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABBV-8E12 was estimated using non-compartmental methods after the first and the fifth doses in Cohort 1 and Cohort J1.
measure: Serum Concentration of ABBV-8E12 Prior to Infusion of a Day of Dosing (Ctrough)
time frame: First day of the Fifth Dosing Interval, Day 85
description: The concentration of ABBV-8E12 immediately prior to infusion of the fifth dose (Ctrough; measured in µg/mL) was estimated using non-compartmental methods in Cohort 1 and Cohort J1.
measure: Mean Change From Baseline to Week 52 in Clinical Global Impression of Severity (CGI-S) Score
time frame: Baseline, Week 52
description: The CGI-S is a clinician's rating of disease severity. The CGI-S rates severity of illness on a 7-point scale, using a range of responses from 1 (normal) through 7 (the most severely ill). This rating is based upon observed and reported symptoms, behavior, and function in the past 7 days. Positive changes in score indicate worsening from baseline.
measure: Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Health Related Quality of Life Scale (PSP-QoL) Total Score
time frame: Baseline, Week 52
description: The PSP-QoL is a validated patient-reported outcome measure, specifically designed to assess the quality of life of participants with PSP. There are 45 items and two subscales: physical and mental impact. Items are scored from 0 (no problem) to 4 (extreme problems). The total subscale sum scores are linearly converted into a 0 to 100 scale, and higher scores indicate a lower quality of life. Positive changes in score indicate a decline in quality of life.
measure: Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Staging System Score (PSP-SS) Score
time frame: Baseline, Week 52
description: The Progressive Supranuclear Palsy Rating Scale (PSPRS) consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for four items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. The PSP-SS score is a composite of the dysphagia and gait items from the PSPRS. Positive changes in score indicate worsening from baseline.
measure: Mean Change From Baseline to Week 52 in Third Ventricle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
time frame: Baseline, Week 52
description: Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify third ventricle atrophy. Positive changes in values indicate an increase in volume.
measure: Mean Change From Baseline to Week 52 in Superior Cerebellar Peduncle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
time frame: Baseline, Week 52
description: Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify Superior cerebellar peduncle atrophy. Negative changes in values indicate a reduction in volume.
measure: Mean Change From Baseline to Week 52 in Brainstem Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
time frame: Baseline, Week 52
description: Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify brainstem atrophy. Negative changes in values indicate a reduction in volume.
measure: Mean Change From Baseline to Week 52 in Whole Brain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
time frame: Baseline, Week 52
description: Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify whole brain atrophy. Negative changes in values indicate a reduction in volume.
measure: Mean Change From Baseline to Week 52 in Frontal Lobe Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)
time frame: Baseline, Week 52
description: Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify frontal lobe atrophy. Positive changes in values indicate an increase in volume.
measure: Time to Loss of Ability to Walk Independently as Measured by Progressive Supranuclear Palsy Rating Scale (PSPRS) Item 26
time frame: From Baseline to Week 52
description: The PSPRS consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for six items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Item 26 pertains to gait, scored as either 0 (normal); 1 (slightly wide-based or irregular or slight pulsion on turns); 2 (must walk slowly or occasionally use walls or helper to avoid falling, especially on turns); 3 (must use assistance all or almost all the time); or 4 (unable to walk, even with walker; may be able to transfer).
arm group label: Placebo
arm group type: Placebo Comparator
description: 0.9% Sodium Chloride Injection/Solution for Infusion; intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks
arm group label: ABBV-8E12 2000 mg
arm group type: Experimental
description: Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)
arm group label: ABBV-8E12 4000 mg
arm group type: Experimental
description: Intravenous infusions at Day 1, Day 15, and Day 29, then every 28 days for 52 weeks; 300 mg/15 mL (participants in countries other than Japan or Spain); 1000 mg/10 mL (for participants in Japan or Spain)
intervention type: Drug
intervention name: Placebo
description: Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr.
arm group label: Placebo
intervention type: Drug
intervention name: ABBV-8E12
description: Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr. For participants in Cohort 2, ABBV-8E12 doses may have been decreased after the evaluation by the Data Monitoring Committee of available safety, tolerability and pharmacokinetic data.
arm group label: ABBV-8E12 2000 mg
arm group label: ABBV-8E12 4000 mg
other name: Tilavonemab
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: AbbVie Inc.
role: Study Director
affiliation: AbbVie
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country: Australia
country: Canada
country: France
country: Germany
country: Italy
country: Japan
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Supranuclear Palsy, Progressive
mesh term: Tilavonemab
sharing ipd: Yes
ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
ipd url: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 