<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/NCT03289143</url>
  </required_header>
  <id_info>
    <org_study_id>GN39763</org_study_id>
    <secondary_id>2017-001800-31</secondary_id>
    <nct_id>NCT03289143</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy and Safety of Semorinemab in Patients With Prodromal to Mild Alzheimer's Disease</brief_title>
  <official_title>A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of MTAU9937A in Patients With Prodromal to Mild Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Genentech, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a phase II, randomized, placebo-controlled, double-blind study to evaluate the&#xD;
      efficacy and safety of Semorinemab in participants with prodromal to mild Alzheimer's&#xD;
      disease. An optional 96-week open-label extension period was available to participants who&#xD;
      completed the double-blind treatment period and who, in the judgment of the investigator,&#xD;
      would potentially benefit from open-label Semorinemab treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study was terminated during Open Label Extension period because analyses of placebo-controlled&#xD;
    Blinded portion of study did not show any evidence of clinical efficacy or modulation of&#xD;
    accumulation of tau PET signal at any of the doses studied.&#xD;
  </why_stopped>
  <start_date type="Actual">October 4, 2017</start_date>
  <completion_date type="Actual">January 15, 2021</completion_date>
  <primary_completion_date type="Actual">January 15, 2021</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Additional blinded personnel will include study site personnel who will evaluate participant status, contract research organization (CRO) personnel who will review case report forms (CRFs), and other sponsor agents (with the exception of the interactive voice or web-based response system [IxRS] vendor).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline on the CDR-SB</measure>
    <time_frame>Baseline and 73 Weeks</time_frame>
    <description>The Clinical Dementia Rating-Sum of Boxes (CDR-SB) rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment = 0, questionable impairment = 0.5 and mild, moderate and severe impairment = 1, 2 and 3 respectively. The score range is from 0 to 18 with a high score indicating a high disease severity. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Adverse Events</measure>
    <time_frame>Up to the data cutoff date 15 January 2021 (up to approximately 39 months)</time_frame>
    <description>Percentage of participants with at least one adverse event</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline on the C-SSRS</measure>
    <time_frame>Baseline to data cutoff date 15 January 2021 (up to approximately 39 months)</time_frame>
    <description>Categories are as defined in the Classification Algorithm for Suicide Assessment (CASA) based on the Columbia Suicide Severity Rating Scale (C-SSRS) questionnaire. SI1: Passive category is &quot;Wish to be dead&quot;, SI2: Active-Nonspecific (no method, intent or plan), SI3: Active-Method, but no intent or Plan, SI4: Active-Method and intent, but no plan in C-SSRS. The worst post-baseline suicidal ideation is the highest across post-baseline visits, with highest as SI5 and lowest as SI1. Percentages are based on the total number of subjects in a treatment group. Baseline is the last observation prior to initiation of study drug.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Other Abnormal MRI Findings</measure>
    <time_frame>Baseline, Week 9, Week 49, Week 73, Study Treatment Discontinuation, and Week 89</time_frame>
    <description>Other abnormal MRI findings by visit. For the Double Blind Period, baseline is defined as last results prior to initiation of study drug. For the Open Label Extension Period, baseline is defined as last results prior to entering the open label period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on the Repeatable Battery for Assessment of Neuropsychological Status (RBANS)</measure>
    <time_frame>Baseline and 73 weeks</time_frame>
    <description>The RBANS is a validated neuropsychological assessment has been shown to be a useful tool in both clinical and research settings. The RBANS consists of ten subtests that are combined to provide five indices, one for each of the five domains tested (immediate memory, visuospatial/constructional, language, attention, and delayed memory). Scores range from 40 to 160 and a higher score indicates better cognitive functioning. A decrease in the outcome measure from baseline corresponds to disease worsening. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on the Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog-13) Subscale Score</measure>
    <time_frame>Baseline and 73 weeks</time_frame>
    <description>The ADAS-Cog-13 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The ADAS-Cog-13 is the ADAS-Cog-11 with 2 further items: delayed word recall and total digit cancellation. The score range for ADAS-Cog-13 is from 0 to 85 with high scores representing severe dysfunction. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on the Amsterdam Instrumental Activity of Daily Living (iADL) Questionnaire</measure>
    <time_frame>Baseline and 73 weeks</time_frame>
    <description>The Amsterdam iADL questionnaire is an informant-based instrument for measuring iADL problems in participants with dementia. This instrument consists of 70 items, scored on a 5-point scale, that uses item response theory for scoring. Items presented to the informant are tailored to responses to earlier items; thus each administration of the Amsterdam iADL may consist of less than the total of 70 items. The resulting score ranges from 20 to 80 with lower scores indicating poorer performance. A decrease in the outcome measure from baseline corresponds to disease worsening. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on the Alzheimer's Disease Cooperative Study Group-Activities of Daily Living Inventory</measure>
    <time_frame>Baseline and 73 weeks</time_frame>
    <description>The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is the scale most widely used to assess functional outcomes in participants with AD. The ADCS-ADL covers both basic ADL (e.g., eating and toileting) and more complex 'instrumental' ADL or iADL (e.g., using the telephone, managing finances and preparing a meal). The ADCS-ADL consists of 23 questions with a score range of 0 to 78 where a higher score represents better function. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Concentrations of Semorinemab at Specified Timepoints</measure>
    <time_frame>Up to 109 weeks</time_frame>
    <description>Serum concentrations of Semorinemab at specified timepoints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of Anti-drug Antibodies During the Study Relative to Their Presence at Baseline</measure>
    <time_frame>Up to 109 weeks</time_frame>
    <description>Presence of anti-drug antibodies during the study relative to their presence at baseline.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">457</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>Dose 1 Semorinemab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose 2 Semorinemab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose 3 Semorinemab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Semorinemab</intervention_name>
    <description>Participants will receive Semorinemab intravenously (IV).</description>
    <arm_group_label>Dose 1 Semorinemab</arm_group_label>
    <arm_group_label>Dose 2 Semorinemab</arm_group_label>
    <arm_group_label>Dose 3 Semorinemab</arm_group_label>
    <other_name>RG6100</other_name>
    <other_name>MTAU9937A</other_name>
    <other_name>RO7105705</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo doses of Semorinemab given intravenously (IV).</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[18F]GTP1</intervention_name>
    <description>[18F]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.</description>
    <arm_group_label>Dose 1 Semorinemab</arm_group_label>
    <arm_group_label>Dose 2 Semorinemab</arm_group_label>
    <arm_group_label>Dose 3 Semorinemab</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>RO6880276</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Age between 50 and 80 years&#xD;
&#xD;
          -  National Institute on Aging/Alzheimer's Association core clinical criteria for&#xD;
             probable Alzheimer's disease (AD) dementia or mild cognitive impairment (prodromal AD)&#xD;
&#xD;
          -  Evidence of the AD pathological process, by a positive amyloid assessment either on&#xD;
             cerebrospinal fluid Aβ1-42 OR amyloid positron emission tomography (PET) scan.&#xD;
             Historical amyloid PET scans may be accepted in some cases&#xD;
&#xD;
          -  Mild AD symptomatology, as defined by a screening Mini-Mental State Examination score&#xD;
             of &gt;= 20 points and Clinical Dementia Rating (CDR) -Global Score of 0.5 or 1&#xD;
&#xD;
          -  Abnormal memory function at screening&#xD;
&#xD;
          -  Availability of a person with sufficient contact with the participant to be able to&#xD;
             provide accurate information on the participant's cognitive and functional ability&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Inability to tolerate magnetic resonance imaging (MRI) procedures or contraindication&#xD;
             to MRI&#xD;
&#xD;
          -  Contraindications to both PET imaging and lumbar dural puncture (must be able to&#xD;
             undergo at least one of these procedures to be eligible)&#xD;
&#xD;
          -  Residence in a skilled nursing facility&#xD;
&#xD;
          -  Any serious medical condition or abnormality in clinical laboratory tests that remains&#xD;
             abnormal on retest and, in the investigator's judgment, precludes the patient's safe&#xD;
             participation in and completion of the study, or bias the assessment of the clinical&#xD;
             or mental status of the participant to a significant degree&#xD;
&#xD;
          -  Any evidence of a condition other than AD that may affect cognition&#xD;
&#xD;
          -  Alcohol or substance abuse within the past 2 years&#xD;
&#xD;
          -  Use of any experimental therapy within 90 days or 5 half-lives prior to screening,&#xD;
             whichever is greater and any passive immunotherapy (immunoglobulin) against tau,&#xD;
             except use of RO7105705 in Genentech Study GN39058, as long as the last dose was at&#xD;
             least 90 days prior to screening&#xD;
&#xD;
          -  Use of any passive immunotherapy (immunoglobulin) against Aβ, unless the last dose was&#xD;
             at least 1 year prior to screening and any active immunotherapy (vaccine) that is&#xD;
             under evaluation to prevent or postpone cognitive decline&#xD;
&#xD;
          -  Any previous treatment with medications specifically intended to treat Parkinsonian&#xD;
             symptoms or any other neurodegenerative disorder within 1 year of screening&#xD;
&#xD;
          -  Systemic immunosuppressive therapy within 12 months of screening through the entire&#xD;
             study period&#xD;
&#xD;
          -  Typical antipsychotic or neuroleptic medication within 6 months of screening&#xD;
&#xD;
          -  Daily treatment with any of the following classes of medication, except for&#xD;
             intermittent short-term use, which is permitted except within 2 days or 5 half-lives&#xD;
             (whichever is longer) prior to any COA: atypical antipsychotics, opiates or opioids,&#xD;
             benzodiazepines, barbiturates, hypnotics, or any medication with clinically&#xD;
             significant centrally-acting antihistamine or anticholinergic activity&#xD;
&#xD;
          -  Stimulant medications, unless the dose has been stable within the 6 months prior to&#xD;
             screening and is expected to be stable throughout the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Genentech, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Clinical Trials</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Irvine</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacology Research Inst</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Neuroscience Health Center (SNHC)</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Research Network - PRN</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurological Research Inst</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Collaborative Neuroscience Network Inc.</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Invicro, a Konica Minolta company</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KI Health Partners, LLC; New England Institute for Clinical Research</name>
      <address>
        <city>Stamford</city>
        <state>Connecticut</state>
        <zip>06905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgetown University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JEM Research LLC</name>
      <address>
        <city>Atlantis</city>
        <state>Florida</state>
        <zip>33462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bradenton Research Center</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brain Matters Research, Inc.</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33445</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neuropsychiatric Research; Center of Southwest Florida</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Jewish Health Systems</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33137</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Collier Neurologic Specialists</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compass Research East, LLC</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stedman Clinical Trials, LLC</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alzheimer's Research and Treatment Center</name>
      <address>
        <city>Wellington</city>
        <state>Florida</state>
        <zip>33414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premiere Research Institute</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University; Global Health</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush Alzheimer's Disease Cntr.</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alexian Brothers Neuroscience Institute</name>
      <address>
        <city>Elk Grove Village</city>
        <state>Illinois</state>
        <zip>60007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Illinois University, School of Medicine</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Maine Medical Center</name>
      <address>
        <city>Bangor</city>
        <state>Maine</state>
        <zip>04401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham &amp; Women's Hosp; TIMI Study Grp</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alzheimers Disease Center</name>
      <address>
        <city>Quincy</city>
        <state>Massachusetts</state>
        <zip>02169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Partners Institute for Education and Research</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NeuroCognitive Institute</name>
      <address>
        <city>Mount Arlington</city>
        <state>New Jersey</state>
        <zip>07856</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Memory Research Institute of NJ</name>
      <address>
        <city>Toms River</city>
        <state>New Jersey</state>
        <zip>08755</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albany Medical College; Neurology</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Empire Neurology PC; MS Center of Northeastern NY</name>
      <address>
        <city>Latham</city>
        <state>New York</state>
        <zip>12110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia Univ Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester; AD-CARE</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summit Research Network Inc.</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abington Neurological Associates</name>
      <address>
        <city>Abington</city>
        <state>Pennsylvania</state>
        <zip>19001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rhode Island Mood &amp; Memory Research Institute</name>
      <address>
        <city>East Providence</city>
        <state>Rhode Island</state>
        <zip>02914</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Butler Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurology Clinic PC</name>
      <address>
        <city>Cordova</city>
        <state>Tennessee</state>
        <zip>38018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Orleans Center For Clinical Research</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neuroscience Research Associates, Inc.</name>
      <address>
        <city>Bennington</city>
        <state>Vermont</state>
        <zip>05201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincents Medical Centre</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Neurology</name>
      <address>
        <city>Kogarah</city>
        <state>New South Wales</state>
        <zip>2217</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queensland University of Technology</name>
      <address>
        <city>Mermaid Waters</city>
        <state>Queensland</state>
        <zip>4218</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Clinical Research Unit; Pharmacy</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HammondCare Aged Psychiatry Clinical Trials</name>
      <address>
        <city>Malvern</city>
        <state>Victoria</state>
        <zip>3144</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Alfred Hospital, Melbourne; Thrombosis and Haemostasis Unit</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neuro Trials Victoria</name>
      <address>
        <city>Noble Park</city>
        <state>Victoria</state>
        <zip>3174</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Melbourne Hospital</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Brussel</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Groeninge</name>
      <address>
        <city>Kortrijk</city>
        <zip>8500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Delta Campus Westlaan</name>
      <address>
        <city>Roeselare</city>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JBN Medical Diagnostic Services; Clinical Trials Division</name>
      <address>
        <city>Burlington</city>
        <state>Ontario</state>
        <zip>L7M 1K9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkwood Institute, Mental Health Care Building</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6C 0A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elisabeth Bruyere Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1N 5C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Memory Program</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M3B 2S7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre for Memory and Aging</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4G 3E8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Sunnybrook Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Western Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Recherches Neuro-Hippocame</name>
      <address>
        <city>Gatineau</city>
        <state>Quebec</state>
        <zip>J8T 8J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center For Clinical and Basic Research (Ccbr); Site Management Organisation</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCBR - Vejle - DK</name>
      <address>
        <city>Vejle</city>
        <zip>7100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Pellegrin; Service de Neurologie - 3ème étage</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Neurologique Pierre Wertheimer</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Roger Salengro</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de la Timone - Hopital d Adultes; Service de Neurologie</name>
      <address>
        <city>Marseille</city>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Gui de Chauliac; Neurologie</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Fernand Widal Centre</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Pitie-Salpetriere</name>
      <address>
        <city>Paris</city>
        <zip>75651</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Hautepierre; ACTR Association Recherche Clinique Rhumatologie</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Strasbourg - Hôpital Hautepierre</name>
      <address>
        <city>Strasbourg</city>
        <zip>67098</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de La Grave</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital des Charpennes</name>
      <address>
        <city>Villeurbanne</city>
        <zip>69100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Bayreuth; Krankenhaus Hohe Warte</name>
      <address>
        <city>Bayreuth</city>
        <zip>95445</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. med. Volker Shumann</name>
      <address>
        <city>Berlin</city>
        <zip>10245</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Studienambulanz emovis GmbH; St. Joseph Krankenhaus</name>
      <address>
        <city>Berlin</city>
        <zip>10626</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite Campus Benjamin Franklin</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurologisch-psychiatrische Praxis am Brosepark</name>
      <address>
        <city>Berlin</city>
        <zip>13156</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bezirkskrankenhaus Günzburg</name>
      <address>
        <city>Günzburg</city>
        <zip>89312</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Hannover-Mitte GmbH</name>
      <address>
        <city>Hannover</city>
        <zip>30159</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar der TU München; Klinik &amp; Poliklinik für Neurologie</name>
      <address>
        <city>München</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ZNS Siegen im MVZ Weidenau</name>
      <address>
        <city>Siegen</city>
        <zip>57076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Tübingen; Psychiatrie und Psychotherapie</name>
      <address>
        <city>Tubingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm; Klinik für Neurologie</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Umberto I Policlinico di Roma-Università di Roma La Sapienza</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00185</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Giovanni Calibita Fatebenefratell;Neurologia</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00186</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria San Martino; Dip. di Neuroscienze Oftalmologia e Genetica</name>
      <address>
        <city>Genova</city>
        <state>Liguria</state>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Centro San Giovanni di Dio FBF</name>
      <address>
        <city>Brescia</city>
        <state>Lombardia</state>
        <zip>25125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Istituto Neurologico Carlo Besta</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA</name>
      <address>
        <city>Pozzilli</city>
        <state>Molise</state>
        <zip>86077</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az. Osp. C. Panico; Rep. Ematologia E Trapianto</name>
      <address>
        <city>Tricase - LE</city>
        <state>Puglia</state>
        <zip>73039</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jeroen Bosch Ziekenhuis</name>
      <address>
        <city>'S Hertogenbosch</city>
        <zip>5223 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brain Research Center B.V</name>
      <address>
        <city>Amsterdam</city>
        <zip>1081 GN</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Podlaskie Centrum Psychogeriatrii</name>
      <address>
        <city>Białystok</city>
        <zip>15-756</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PALLMED Sp. z o.o. prowadząca NZOZ DOM SUE RYDER</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-796</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M.A. - LEK A.M.Maciejowscy SC.</name>
      <address>
        <city>Katowice</city>
        <zip>40-595</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo-Med Zielinski i wspolnicy Sp. j.</name>
      <address>
        <city>Katowice</city>
        <zip>40-650</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Malopolskie Centrum Medyczne</name>
      <address>
        <city>Krakow</city>
        <zip>30-510</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NEURO - KARD Ośrodek Badań Klinicznych</name>
      <address>
        <city>Poznań</city>
        <zip>61-853</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NEURO-CARE Sp. z o.o. Sp. Komandytowa</name>
      <address>
        <city>Siemianowice Śląskie</city>
        <zip>41-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Senior Sp. Z O.O. Poradnia Psychogeriatryczna</name>
      <address>
        <city>Sopot</city>
        <zip>81-855</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EroMedis</name>
      <address>
        <city>Szczecin</city>
        <zip>70-11</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMED Medical Center</name>
      <address>
        <city>Warszawa</city>
        <zip>01-518</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne NeuroProtect</name>
      <address>
        <city>Warszawa</city>
        <zip>01-684</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ WCA</name>
      <address>
        <city>Wrocław</city>
        <zip>53-659</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Mutua de Terrassa</name>
      <address>
        <city>Terrassa</city>
        <state>Barcelona</state>
        <zip>08221</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinica Guipuzcoa</name>
      <address>
        <city>San Sebastian</city>
        <state>Guipuzcoa</state>
        <zip>20009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universitaria de Navarra; Servicio de Neurología</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen del Puerto</name>
      <address>
        <city>Plasencia</city>
        <state>Palencia</state>
        <zip>10600</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Cruces; Servicio de Neurologia</name>
      <address>
        <city>Barakaldo</city>
        <state>Vizcaya</state>
        <zip>48903</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Perpetuo Socorro, Servicio de Geriatria</name>
      <address>
        <city>Albacete</city>
        <zip>2006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación ACE; Servicio de Neurología</name>
      <address>
        <city>Barcelona</city>
        <zip>08028</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic i Provincial de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofia; Servicio de Neurologia</name>
      <address>
        <city>Cordoba</city>
        <zip>14011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramon y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Cantoblanco; Servicio de Geriatria</name>
      <address>
        <city>Madrid</city>
        <zip>28049</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen Macarena</name>
      <address>
        <city>Sevilla</city>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Dr. Peset; Servicio de Neurologia</name>
      <address>
        <city>Valencia</city>
        <zip>46017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari i Politecnic La Fe de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Länssjukhuset Ryhov</name>
      <address>
        <city>Jönköping</city>
        <zip>551 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Länssjukhuset Kalmar; Oncology</name>
      <address>
        <city>Kalmar</city>
        <zip>39185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skane University Hospital Malmo/Lund, Dept.of Hematology and Coagulation Disorders</name>
      <address>
        <city>Malmö</city>
        <zip>212 24</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sahlgrenska Univ Hospital Mölndal; Department of Nephrology</name>
      <address>
        <city>Mölndal</city>
        <zip>S-431 80</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Universitetssjukhuset Huddinge</name>
      <address>
        <city>Stockholm</city>
        <zip>171 64</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glasgow Memory Clinic</name>
      <address>
        <city>Glasgow</city>
        <zip>G20 0XA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RE:Cognition Health</name>
      <address>
        <city>London</city>
        <zip>W1G 9RU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The National Hospital for Neurology &amp; Neurosurgery</name>
      <address>
        <city>London</city>
        <zip>WC1N 3BG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Re:Cognition Health Guildford</name>
      <address>
        <city>Surrey</city>
        <zip>GU2 7YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Finland</country>
  </removed_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <results_first_submitted>January 4, 2022</results_first_submitted>
  <results_first_submitted_qc>February 16, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 16, 2022</results_first_posted>
  <last_update_submitted>February 16, 2022</last_update_submitted>
  <last_update_submitted_qc>February 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alzheimer Disease</keyword>
  <keyword>Brain Diseases</keyword>
  <keyword>Dementia</keyword>
  <keyword>Neurodegenerative Diseases</keyword>
  <keyword>Neurocognitive Disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 11, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03289143/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>August 16, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03289143/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>The study consisted of a double-blind treatment period and an optional open-label extension (OLE) period. OLE period was available to participants who completed the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label semorinemab treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo Double Blind Period</title>
          <description>Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.</description>
        </group>
        <group group_id="P2">
          <title>Dose 1 Semorinemab Double Blind Period</title>
          <description>Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.</description>
        </group>
        <group group_id="P3">
          <title>Dose 2 Semorinemab Double Blind Period</title>
          <description>Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.</description>
        </group>
        <group group_id="P4">
          <title>Dose 3 Semorinemab Double Blind Period</title>
          <description>Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="135"/>
                <participants group_id="P2" count="94"/>
                <participants group_id="P3" count="136"/>
                <participants group_id="P4" count="92"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="134"/>
                <participants group_id="P2" count="94"/>
                <participants group_id="P3" count="134"/>
                <participants group_id="P4" count="92"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Caregiver Unavailability</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Research Department Closure</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Caregiver and Participant Withdrew Consent</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Medical Monitor Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant Non-Compliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Drug Interrupted for Too Long Due to Prohibited Med</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant Non Compliance With Concomitant Medications</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Caregiver Passed Away</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated By Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="75"/>
                <participants group_id="P3" count="100"/>
                <participants group_id="P4" count="69"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="14"/>
                <participants group_id="P4" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant No Longer Has Study Partner</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Caregiver</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Caregiver Passed Away &amp; Family Moved Out of State</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Absence of Consistent and Reliable Caregiver</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo Double Blind Period</title>
          <description>Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.</description>
        </group>
        <group group_id="B2">
          <title>Dose 1 Semorinemab Double Blind Period</title>
          <description>Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.</description>
        </group>
        <group group_id="B3">
          <title>Dose 2 Semorinemab Double Blind Period</title>
          <description>Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.</description>
        </group>
        <group group_id="B4">
          <title>Dose 3 Semorinemab Double Blind Period</title>
          <description>Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="135"/>
            <count group_id="B2" value="94"/>
            <count group_id="B3" value="136"/>
            <count group_id="B4" value="92"/>
            <count group_id="B5" value="457"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.7" spread="7.3"/>
                    <measurement group_id="B2" value="70.2" spread="6.7"/>
                    <measurement group_id="B3" value="69.3" spread="7.1"/>
                    <measurement group_id="B4" value="69.6" spread="6.7"/>
                    <measurement group_id="B5" value="69.6" spread="6.9"/>
                  </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="75"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="79"/>
                    <measurement group_id="B4" value="48"/>
                    <measurement group_id="B5" value="253"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="57"/>
                    <measurement group_id="B4" value="44"/>
                    <measurement group_id="B5" value="204"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="126"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="125"/>
                    <measurement group_id="B4" value="79"/>
                    <measurement group_id="B5" value="410"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="129"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="128"/>
                    <measurement group_id="B4" value="82"/>
                    <measurement group_id="B5" value="422"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline on the CDR-SB</title>
        <description>The Clinical Dementia Rating-Sum of Boxes (CDR-SB) rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment = 0, questionable impairment = 0.5 and mild, moderate and severe impairment = 1, 2 and 3 respectively. The score range is from 0 to 18 with a high score indicating a high disease severity. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.</description>
        <time_frame>Baseline and 73 Weeks</time_frame>
        <population>Modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of study drug and had at least one postbaseline primary efficacy Clinical Dementia Rating-Sum of Boxes (CDR-SB) measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Double Blind Period</title>
            <description>Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Dose 1 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Dose 2 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Dose 3 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the CDR-SB</title>
          <description>The Clinical Dementia Rating-Sum of Boxes (CDR-SB) rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment = 0, questionable impairment = 0.5 and mild, moderate and severe impairment = 1, 2 and 3 respectively. The score range is from 0 to 18 with a high score indicating a high disease severity. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.</description>
          <population>Modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of study drug and had at least one postbaseline primary efficacy Clinical Dementia Rating-Sum of Boxes (CDR-SB) measurement.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="113"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.19" spread="0.226"/>
                    <measurement group_id="O2" value="2.36" spread="0.268"/>
                    <measurement group_id="O3" value="2.36" spread="0.222"/>
                    <measurement group_id="O4" value="2.41" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6147</p_value>
            <p_value_desc>Unadjusted</p_value_desc>
            <method>Mixed-effect Model Repeated Measures</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5778</p_value>
            <p_value_desc>Unadjusted</p_value_desc>
            <method>Mixed-effect Model Repeated Measures</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5136</p_value>
            <p_value_desc>Unadjusted</p_value_desc>
            <method>Mixed-effect Model Repeated Measures</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Adverse Events</title>
        <description>Percentage of participants with at least one adverse event</description>
        <time_frame>Up to the data cutoff date 15 January 2021 (up to approximately 39 months)</time_frame>
        <population>The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (MTAU9937A or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Double Blind Period</title>
            <description>Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Dose 1 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Dose 2 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Dose 3 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Dose 2 Semorinemab Open Label Extension Period</title>
            <description>Semorinemab was administered intravenously at dose 2 in the open-label extension period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Adverse Events</title>
          <description>Percentage of participants with at least one adverse event</description>
          <population>The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (MTAU9937A or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="132"/>
                <count group_id="O4" value="90"/>
                <count group_id="O5" value="360"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.1"/>
                    <measurement group_id="O2" value="88.8"/>
                    <measurement group_id="O3" value="94.7"/>
                    <measurement group_id="O4" value="92.2"/>
                    <measurement group_id="O5" value="47.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on the Repeatable Battery for Assessment of Neuropsychological Status (RBANS)</title>
        <description>The RBANS is a validated neuropsychological assessment has been shown to be a useful tool in both clinical and research settings. The RBANS consists of ten subtests that are combined to provide five indices, one for each of the five domains tested (immediate memory, visuospatial/constructional, language, attention, and delayed memory). Scores range from 40 to 160 and a higher score indicates better cognitive functioning. A decrease in the outcome measure from baseline corresponds to disease worsening. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.</description>
        <time_frame>Baseline and 73 weeks</time_frame>
        <population>Modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of study drug and had at least one postbaseline primary efficacy Clinical Dementia Rating-Sum of Boxes (CDR-SB) measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Double Blind Period</title>
            <description>Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Dose 1 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Dose 2 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Dose 3 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the Repeatable Battery for Assessment of Neuropsychological Status (RBANS)</title>
          <description>The RBANS is a validated neuropsychological assessment has been shown to be a useful tool in both clinical and research settings. The RBANS consists of ten subtests that are combined to provide five indices, one for each of the five domains tested (immediate memory, visuospatial/constructional, language, attention, and delayed memory). Scores range from 40 to 160 and a higher score indicates better cognitive functioning. A decrease in the outcome measure from baseline corresponds to disease worsening. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.</description>
          <population>Modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of study drug and had at least one postbaseline primary efficacy Clinical Dementia Rating-Sum of Boxes (CDR-SB) measurement.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="93"/>
                <count group_id="O4" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.53" spread="0.787"/>
                    <measurement group_id="O2" value="-5.25" spread="0.93"/>
                    <measurement group_id="O3" value="-4.62" spread="0.765"/>
                    <measurement group_id="O4" value="-6.15" spread="0.926"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8198</p_value>
            <p_value_desc>Unadjusted</p_value_desc>
            <method>Mixed-effect Model Repeated Measures</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3961</p_value>
            <p_value_desc>Unadjusted</p_value_desc>
            <method>Mixed-effect Model Repeated Measures</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6043</p_value>
            <p_value_desc>Unadjusted</p_value_desc>
            <method>Mixed-effect Model Repeated Measures</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on the Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog-13) Subscale Score</title>
        <description>The ADAS-Cog-13 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The ADAS-Cog-13 is the ADAS-Cog-11 with 2 further items: delayed word recall and total digit cancellation. The score range for ADAS-Cog-13 is from 0 to 85 with high scores representing severe dysfunction. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.</description>
        <time_frame>Baseline and 73 weeks</time_frame>
        <population>Modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of study drug and had at least one postbaseline primary efficacy Clinical Dementia Rating-Sum of Boxes (CDR-SB) measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Double Blind Period</title>
            <description>Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Dose 1 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Dose 2 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Dose 3 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog-13) Subscale Score</title>
          <description>The ADAS-Cog-13 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The ADAS-Cog-13 is the ADAS-Cog-11 with 2 further items: delayed word recall and total digit cancellation. The score range for ADAS-Cog-13 is from 0 to 85 with high scores representing severe dysfunction. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.</description>
          <population>Modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of study drug and had at least one postbaseline primary efficacy Clinical Dementia Rating-Sum of Boxes (CDR-SB) measurement.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="97"/>
                <count group_id="O4" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.56" spread="0.777"/>
                    <measurement group_id="O2" value="8.68" spread="0.937"/>
                    <measurement group_id="O3" value="6" spread="0.769"/>
                    <measurement group_id="O4" value="7.58" spread="0.932"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0783</p_value>
            <p_value_desc>Unadjusted</p_value_desc>
            <method>Mixed-effect Model Repeated Measures</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6010</p_value>
            <p_value_desc>Unadjusted</p_value_desc>
            <method>Mixed-effect Model Repeated Measures</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3961</p_value>
            <p_value_desc>Unadjusted</p_value_desc>
            <method>Mixed-effect Model Repeated Measures</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on the Amsterdam Instrumental Activity of Daily Living (iADL) Questionnaire</title>
        <description>The Amsterdam iADL questionnaire is an informant-based instrument for measuring iADL problems in participants with dementia. This instrument consists of 70 items, scored on a 5-point scale, that uses item response theory for scoring. Items presented to the informant are tailored to responses to earlier items; thus each administration of the Amsterdam iADL may consist of less than the total of 70 items. The resulting score ranges from 20 to 80 with lower scores indicating poorer performance. A decrease in the outcome measure from baseline corresponds to disease worsening. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.</description>
        <time_frame>Baseline and 73 weeks</time_frame>
        <population>Modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of study drug and had at least one postbaseline primary efficacy Clinical Dementia Rating-Sum of Boxes (CDR-SB) measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Double Blind Period</title>
            <description>Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Dose 1 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Dose 2 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Dose 3 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the Amsterdam Instrumental Activity of Daily Living (iADL) Questionnaire</title>
          <description>The Amsterdam iADL questionnaire is an informant-based instrument for measuring iADL problems in participants with dementia. This instrument consists of 70 items, scored on a 5-point scale, that uses item response theory for scoring. Items presented to the informant are tailored to responses to earlier items; thus each administration of the Amsterdam iADL may consist of less than the total of 70 items. The resulting score ranges from 20 to 80 with lower scores indicating poorer performance. A decrease in the outcome measure from baseline corresponds to disease worsening. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.</description>
          <population>Modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of study drug and had at least one postbaseline primary efficacy Clinical Dementia Rating-Sum of Boxes (CDR-SB) measurement.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="70"/>
                <count group_id="O3" value="109"/>
                <count group_id="O4" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.59" spread="0.856"/>
                    <measurement group_id="O2" value="-6.55" spread="0.999"/>
                    <measurement group_id="O3" value="-6.92" spread="0.824"/>
                    <measurement group_id="O4" value="-7.31" spread="1.013"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9749</p_value>
            <p_value_desc>Unadjusted</p_value_desc>
            <method>Mixed-effect Model Repeated Measures</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7718</p_value>
            <p_value_desc>Unadjusted</p_value_desc>
            <method>Mixed-effect Model Repeated Measures</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5789</p_value>
            <p_value_desc>Unadjusted</p_value_desc>
            <method>Mixed-effect Model Repeated Measures</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on the Alzheimer's Disease Cooperative Study Group-Activities of Daily Living Inventory</title>
        <description>The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is the scale most widely used to assess functional outcomes in participants with AD. The ADCS-ADL covers both basic ADL (e.g., eating and toileting) and more complex 'instrumental' ADL or iADL (e.g., using the telephone, managing finances and preparing a meal). The ADCS-ADL consists of 23 questions with a score range of 0 to 78 where a higher score represents better function. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.</description>
        <time_frame>Baseline and 73 weeks</time_frame>
        <population>Modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of study drug and had at least one postbaseline primary efficacy Clinical Dementia Rating-Sum of Boxes (CDR-SB) measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Double Blind Period</title>
            <description>Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Dose 1 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Dose 2 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Dose 3 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the Alzheimer's Disease Cooperative Study Group-Activities of Daily Living Inventory</title>
          <description>The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is the scale most widely used to assess functional outcomes in participants with AD. The ADCS-ADL covers both basic ADL (e.g., eating and toileting) and more complex 'instrumental' ADL or iADL (e.g., using the telephone, managing finances and preparing a meal). The ADCS-ADL consists of 23 questions with a score range of 0 to 78 where a higher score represents better function. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.</description>
          <population>Modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of study drug and had at least one postbaseline primary efficacy Clinical Dementia Rating-Sum of Boxes (CDR-SB) measurement.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="104"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="112"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.55" spread="0.996"/>
                    <measurement group_id="O2" value="-9.52" spread="1.179"/>
                    <measurement group_id="O3" value="-7.75" spread="0.986"/>
                    <measurement group_id="O4" value="-7.99" spread="1.183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5235</p_value>
            <p_value_desc>Unadjusted</p_value_desc>
            <method>Mixed-effect Model Repeated Measures</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5612</p_value>
            <p_value_desc>Unadjusted</p_value_desc>
            <method>Mixed-effect Model Repeated Measures</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7130</p_value>
            <p_value_desc>Unadjusted</p_value_desc>
            <method>Mixed-effect Model Repeated Measures</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Concentrations of Semorinemab at Specified Timepoints</title>
        <description>Serum concentrations of Semorinemab at specified timepoints.</description>
        <time_frame>Up to 109 weeks</time_frame>
        <population>The PK-evaluable population is defined as patients who received Semorinemab treatment and had at least one measureable PK concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose 1 Semorinemab Double Blind and Open Label Extension Periods</title>
            <description>Semorinemab was administered intravenously at dose 1 in the double-blind treatment period. Optional Open Label Extension was available to participants who completed the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label extension.</description>
          </group>
          <group group_id="O2">
            <title>Dose 2 Semorinemab Double Blind and Open Label Extension Periods</title>
            <description>Semorinemab was administered intravenously at dose 2 in the double-blind treatment period. Optional Open Label Extension was available to participants who completed the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label extension.</description>
          </group>
          <group group_id="O3">
            <title>Dose 3 Semorinemab Double Blind and Open Label Extension Periods</title>
            <description>Semorinemab was administered intravenously at dose 3 in the double-blind treatment period. Optional Open Label Extension was available to participants who completed the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label extension.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Concentrations of Semorinemab at Specified Timepoints</title>
          <description>Serum concentrations of Semorinemab at specified timepoints.</description>
          <population>The PK-evaluable population is defined as patients who received Semorinemab treatment and had at least one measureable PK concentration.</population>
          <units>ug/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="132"/>
                <count group_id="O3" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1, 0-4 Hours Predose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="132"/>
                    <count group_id="O3" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Not reportable. Below the level of detection.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Not reportable. Below the level of detection.</measurement>
                    <measurement group_id="O3" value="NA" spread="NA">Not reportable. Below the level of detection.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1, 1 Hour Postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="132"/>
                    <count group_id="O3" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="472" spread="131"/>
                    <measurement group_id="O2" value="1580" spread="496"/>
                    <measurement group_id="O3" value="2690" spread="689"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1, 2 Hours Postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="130"/>
                    <count group_id="O3" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="476" spread="123"/>
                    <measurement group_id="O2" value="1510" spread="419"/>
                    <measurement group_id="O3" value="2600" spread="707"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1, 4 Hours postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="463" spread="135"/>
                    <measurement group_id="O2" value="1370" spread="405"/>
                    <measurement group_id="O3" value="2570" spread="785"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3, 0-4 hours Predose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="131"/>
                    <count group_id="O3" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="184" spread="52.7"/>
                    <measurement group_id="O2" value="601" spread="211"/>
                    <measurement group_id="O3" value="1100" spread="449"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3, 30 min Post dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="130"/>
                    <count group_id="O3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="718" spread="198"/>
                    <measurement group_id="O2" value="2320" spread="581"/>
                    <measurement group_id="O3" value="4190" spread="1010"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5, 0-4 Hours Predose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="131"/>
                    <count group_id="O3" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="318" spread="81.5"/>
                    <measurement group_id="O2" value="955" spread="256"/>
                    <measurement group_id="O3" value="1920" spread="614"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5, 30 min Postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="130"/>
                    <count group_id="O3" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="908" spread="508"/>
                    <measurement group_id="O2" value="2780" spread="695"/>
                    <measurement group_id="O3" value="4860" spread="1250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9, 0-4 hours Predose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="130"/>
                    <count group_id="O3" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="344" spread="128"/>
                    <measurement group_id="O2" value="961" spread="288"/>
                    <measurement group_id="O3" value="1840" spread="513"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9, 30 Minutes Postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="129"/>
                    <count group_id="O3" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="889" spread="321"/>
                    <measurement group_id="O2" value="2790" spread="757"/>
                    <measurement group_id="O3" value="4960" spread="1270"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13, 0-4 Hours Predose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="128"/>
                    <count group_id="O3" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="360" spread="105"/>
                    <measurement group_id="O2" value="1060" spread="333"/>
                    <measurement group_id="O3" value="1910" spread="545"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13, 30 Minutes Postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="127"/>
                    <count group_id="O3" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="998" spread="896"/>
                    <measurement group_id="O2" value="2900" spread="668"/>
                    <measurement group_id="O3" value="4880" spread="1250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="1750" spread="NA">Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 17, 0-4 Hours Predose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="127"/>
                    <count group_id="O3" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="386" spread="116"/>
                    <measurement group_id="O2" value="1040" spread="316"/>
                    <measurement group_id="O3" value="1890" spread="522"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 17, 30 Minutes Postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="126"/>
                    <count group_id="O3" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="819" spread="242"/>
                    <measurement group_id="O2" value="2930" spread="902"/>
                    <measurement group_id="O3" value="4770" spread="1270"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 33, 0-4 Hours Predose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="126"/>
                    <count group_id="O3" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="404" spread="134"/>
                    <measurement group_id="O2" value="960" spread="277"/>
                    <measurement group_id="O3" value="2050" spread="648"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 33, 30 Minutes Postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="126"/>
                    <count group_id="O3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="801" spread="260"/>
                    <measurement group_id="O2" value="2540" spread="853"/>
                    <measurement group_id="O3" value="4800" spread="1200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 49, 0-4 Hours Predose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="119"/>
                    <count group_id="O3" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="377" spread="105"/>
                    <measurement group_id="O2" value="1060" spread="332"/>
                    <measurement group_id="O3" value="2160" spread="605"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 49, 30 Minutes Postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="117"/>
                    <count group_id="O3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="871" spread="260"/>
                    <measurement group_id="O2" value="2810" spread="967"/>
                    <measurement group_id="O3" value="4960" spread="1030"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 65</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="2100" spread="NA">Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 65, 0-4 Hours Predose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="101"/>
                    <count group_id="O3" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="405" spread="127"/>
                    <measurement group_id="O2" value="1170" spread="276"/>
                    <measurement group_id="O3" value="2020" spread="681"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 65, 30 Minutes Postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="963" spread="401"/>
                    <measurement group_id="O2" value="2930" spread="830"/>
                    <measurement group_id="O3" value="4710" spread="1450"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 73</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="104"/>
                    <count group_id="O3" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="327" spread="154"/>
                    <measurement group_id="O2" value="1030" spread="451"/>
                    <measurement group_id="O3" value="1830" spread="752"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 73, 0-4 Hours Predose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="382" spread="NA">Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 73, 1 Hour Postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1910" spread="NA">Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 73, 2 Hours Postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1740" spread="NA">Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 73, 4 Hours Postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1710" spread="NA">Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 77 OLE, 0-4 Hours Predose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="180" spread="71.0"/>
                    <measurement group_id="O2" value="724" spread="167"/>
                    <measurement group_id="O3" value="1030" spread="345"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 77 OLE, 1 hour Postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1700" spread="523"/>
                    <measurement group_id="O2" value="2460" spread="868"/>
                    <measurement group_id="O3" value="2670" spread="707"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 77 OLE, 2 hours Postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1830" spread="552"/>
                    <measurement group_id="O2" value="2270" spread="442"/>
                    <measurement group_id="O3" value="2510" spread="579"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 77 OLE, 4 hours Postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1850" spread="516"/>
                    <measurement group_id="O2" value="2270" spread="480"/>
                    <measurement group_id="O3" value="2790" spread="558"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 93 OLE, 0-4 Hours Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="632" spread="37.5"/>
                    <measurement group_id="O2" value="1040" spread="113"/>
                    <measurement group_id="O3" value="1290" spread="307"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 93 OLE, 30 Minutes Postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1920" spread="431"/>
                    <measurement group_id="O2" value="2570" spread="91.9"/>
                    <measurement group_id="O3" value="2880" spread="492"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 109 OLE, 0-4 Hours Predose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1270" spread="NA">Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 109 OLE, 30 Minutes Postdose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3330" spread="NA">Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Presence of Anti-drug Antibodies During the Study Relative to Their Presence at Baseline</title>
        <description>Presence of anti-drug antibodies during the study relative to their presence at baseline.</description>
        <time_frame>Up to 109 weeks</time_frame>
        <population>The immunogenicity analyses will include participants with at least one predose and one postdose ADA assessment, with participants grouped according to treatment arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Double Blind Period</title>
            <description>Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Dose 1 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Dose 2 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Dose 3 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Presence of Anti-drug Antibodies During the Study Relative to Their Presence at Baseline</title>
          <description>Presence of anti-drug antibodies during the study relative to their presence at baseline.</description>
          <population>The immunogenicity analyses will include participants with at least one predose and one postdose ADA assessment, with participants grouped according to treatment arm.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="132"/>
                <count group_id="O4" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="87"/>
                    <count group_id="O3" value="132"/>
                    <count group_id="O4" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="128"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline on the C-SSRS</title>
        <description>Categories are as defined in the Classification Algorithm for Suicide Assessment (CASA) based on the Columbia Suicide Severity Rating Scale (C-SSRS) questionnaire. SI1: Passive category is &quot;Wish to be dead&quot;, SI2: Active-Nonspecific (no method, intent or plan), SI3: Active-Method, but no intent or Plan, SI4: Active-Method and intent, but no plan in C-SSRS. The worst post-baseline suicidal ideation is the highest across post-baseline visits, with highest as SI5 and lowest as SI1. Percentages are based on the total number of subjects in a treatment group. Baseline is the last observation prior to initiation of study drug.</description>
        <time_frame>Baseline to data cutoff date 15 January 2021 (up to approximately 39 months)</time_frame>
        <population>The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (MTAU9937A or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Double Blind Period</title>
            <description>Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Dose 1 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Dose 2 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Dose 3 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Dose 2 Semorinemab Open Label Extension Period</title>
            <description>Semorinemab was administered intravenously at dose 2 in the open-label extension period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the C-SSRS</title>
          <description>Categories are as defined in the Classification Algorithm for Suicide Assessment (CASA) based on the Columbia Suicide Severity Rating Scale (C-SSRS) questionnaire. SI1: Passive category is &quot;Wish to be dead&quot;, SI2: Active-Nonspecific (no method, intent or plan), SI3: Active-Method, but no intent or Plan, SI4: Active-Method and intent, but no plan in C-SSRS. The worst post-baseline suicidal ideation is the highest across post-baseline visits, with highest as SI5 and lowest as SI1. Percentages are based on the total number of subjects in a treatment group. Baseline is the last observation prior to initiation of study drug.</description>
          <population>The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (MTAU9937A or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.</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="130"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="132"/>
                <count group_id="O4" value="90"/>
                <count group_id="O5" value="360"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Missing/No Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing/SI1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing/SI2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing/SI3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing/SI4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing/Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Event/No Event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119"/>
                    <measurement group_id="O2" value="80"/>
                    <measurement group_id="O3" value="123"/>
                    <measurement group_id="O4" value="83"/>
                    <measurement group_id="O5" value="336"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Event/SI1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Event/ SI2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Event/SI3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Event/ SI4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Event/ Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI1/No Event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI1/SI1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI1/SI2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI1/SI3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI1/SI4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI1/Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI2/No Event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI2/SI1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI2/SI2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI2/SI3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI2/SI4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI2/Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI3/No Event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI3/SI1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI3/SI2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI3/SI3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI3/SI4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI3/Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI4/No Event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI4/SI1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI4/SI2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI4/SI3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SI4/Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Other Abnormal MRI Findings</title>
        <description>Other abnormal MRI findings by visit. For the Double Blind Period, baseline is defined as last results prior to initiation of study drug. For the Open Label Extension Period, baseline is defined as last results prior to entering the open label period.</description>
        <time_frame>Baseline, Week 9, Week 49, Week 73, Study Treatment Discontinuation, and Week 89</time_frame>
        <population>The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (MTAU9937A or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Double Blind Period</title>
            <description>Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.</description>
          </group>
          <group group_id="O2">
            <title>Dose 1 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.</description>
          </group>
          <group group_id="O3">
            <title>Dose 2 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.</description>
          </group>
          <group group_id="O4">
            <title>Dose 3 Semorinemab Double Blind Period</title>
            <description>Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.</description>
          </group>
          <group group_id="O5">
            <title>Dose 2 Semorinemab Open Label Extension Period</title>
            <description>Semorinemab was administered intravenously at dose 2 in the open-label extension period.</description>
          </group>
        </group_list>
        <measure>
          <title>Other Abnormal MRI Findings</title>
          <description>Other abnormal MRI findings by visit. For the Double Blind Period, baseline is defined as last results prior to initiation of study drug. For the Open Label Extension Period, baseline is defined as last results prior to entering the open label period.</description>
          <population>The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (MTAU9937A or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.</population>
          <units>Number of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="135"/>
                <count group_id="O2" value="94"/>
                <count group_id="O3" value="136"/>
                <count group_id="O4" value="92"/>
                <count group_id="O5" value="360"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cerebrovascular Pathology, Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CNS Trauma, Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intracranial Tumor, Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lacunar Infarct, Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Superficial Hemosiderosis, Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Territorial Infarct, Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vasogenic Edema/Sulcal Effusion, Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cerebrovascular Pathology, Week 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CNS Trauma, Week 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intracranial Tumor, Week 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lacunar Infarct, Week 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Superficial Hemosiderosis, Week 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Territorial Infarct, Week 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vasogenic Edema/Sulcal Effusion, Week 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cerebrovascular Pathology, Week 49</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CNS Trauma, Week 49</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intracranial Tumor, Week 49</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lacunar Infarct, Week 49</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Superficial Hemosiderosis, Week 49</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Territorial Infarct, Week 49</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vasogenic Edema/Sulcal Effusion, Week 49</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cerebrovascular Pathology, Week 73</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CNS Trauma, Week 73</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intracranial Tumor, Week 73</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lacunar Infarct, Week 73</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Superficial Hemosiderosis, Week 73</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Territorial Infarct, Week 73</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vasogenic Edema/Sulcal Effusion, Week 73</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cerebrovascular Pathology, Study Treatment Early Discontinuation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CSN Trauma, Study Treatment Early Discontinuation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intracranial Tumor, Study Treatment Early Discontinuation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lucunar Infarct, Study Treatment Early Discontinuation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Superficial Hemosiderosis, Study Treatment Early Discontinuation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Territorial Infarct, Study Treatment Early Discontinuation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vasogenic Edema/Sulcal Effusion, Study Treatment Early Discontinuation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="135"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="136"/>
                    <count group_id="O4" value="92"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cerebrovascular Pathology, Week 89 Open Label Extension (OLE)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CNS Trauma, Week 89 OLE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intracranial Tumor, Week 89 OLE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lacunar Infarct, Week 89 OLE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Superficial Hemosiderosis, Week 89 OLE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Territorial Infarct, Week 89 OLE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vasogenic Edema/Sulcal Effusion, Week 89 OLE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months)</time_frame>
      <desc>The safety-evaluable population included all participants who were randomly allocated and received at least one dose of study drug (semorinemab or placebo) during the double-blind treatment period with treatment groups defined according to actual treatment received.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo Double Blind Period</title>
          <description>Matching placebo dose of Semorinemab was administered intravenously in the double-blind treatment period.</description>
        </group>
        <group group_id="E2">
          <title>Dose 1 Semorinemab Double Blind Period</title>
          <description>Semorinemab was administered intravenously at dose 1 in the double-blind treatment period.</description>
        </group>
        <group group_id="E3">
          <title>Dose 2 Semorinemab Double Blind Period</title>
          <description>Semorinemab was administered intravenously at dose 2 in the double-blind treatment period.</description>
        </group>
        <group group_id="E4">
          <title>Dose 3 Semorinemab Double Blind Period</title>
          <description>Semorinemab was administered intravenously at dose 3 in the double-blind treatment period.</description>
        </group>
        <group group_id="E5">
          <title>Dose 2 Semorinemab Open Label</title>
          <description>Semorinemab was administered intravenously at dose 2 in the open-label extension period.</description>
        </group>
      </group_list>
      <serious_events>
        <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="2" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="132"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="90"/>
                <counts group_id="E5" subjects_affected="17" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Atrioventricular block</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Congestive cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Sinus node dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Inguinal hernia strangulated</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Rectal polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Euthanasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </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="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Parainfluenzae virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Peritonsillar abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Face injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Fracture displacement</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Skin wound</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Fracture pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Benign pancreatic neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Bladder transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Chronic lymphocytic leukaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Colorectal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Renal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Amnesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Cluster headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Coma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Post-traumatic headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Toxic encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Aggression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Paranoia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Persecutory delusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Calculus urinary</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Urinary bladder polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Tonsillar cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="76" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="57" subjects_at_risk="89"/>
                <counts group_id="E3" subjects_affected="88" subjects_at_risk="132"/>
                <counts group_id="E4" subjects_affected="60" subjects_at_risk="90"/>
                <counts group_id="E5" subjects_affected="76" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="130"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="89"/>
                <counts group_id="E3" events="11" subjects_affected="10" subjects_at_risk="132"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="90"/>
                <counts group_id="E5" events="6" subjects_affected="5" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="89"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="132"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="90"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="132"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E5" events="3" subjects_affected="1" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="15" subjects_affected="11" subjects_at_risk="130"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="89"/>
                <counts group_id="E3" events="24" subjects_affected="18" subjects_at_risk="132"/>
                <counts group_id="E4" events="14" subjects_affected="12" subjects_at_risk="90"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="21" subjects_affected="15" subjects_at_risk="130"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="89"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="132"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="13" subjects_affected="10" subjects_at_risk="130"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="89"/>
                <counts group_id="E3" events="11" subjects_affected="10" subjects_at_risk="132"/>
                <counts group_id="E4" events="8" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E5" events="11" subjects_affected="10" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="26" subjects_affected="22" subjects_at_risk="130"/>
                <counts group_id="E2" events="15" subjects_affected="14" subjects_at_risk="89"/>
                <counts group_id="E3" events="33" subjects_affected="22" subjects_at_risk="132"/>
                <counts group_id="E4" events="11" subjects_affected="7" subjects_at_risk="90"/>
                <counts group_id="E5" events="21" subjects_affected="18" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="130"/>
                <counts group_id="E2" events="16" subjects_affected="10" subjects_at_risk="89"/>
                <counts group_id="E3" events="15" subjects_affected="11" subjects_at_risk="132"/>
                <counts group_id="E4" events="11" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="130"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="89"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="132"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="130"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
                <counts group_id="E3" events="12" subjects_affected="8" subjects_at_risk="132"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="130"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="89"/>
                <counts group_id="E3" events="12" subjects_affected="10" subjects_at_risk="132"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="90"/>
                <counts group_id="E5" events="8" subjects_affected="8" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="130"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="89"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="132"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="130"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="89"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="132"/>
                <counts group_id="E4" events="9" subjects_affected="7" subjects_at_risk="90"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="13" subjects_affected="10" subjects_at_risk="130"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="89"/>
                <counts group_id="E3" events="11" subjects_affected="8" subjects_at_risk="132"/>
                <counts group_id="E4" events="9" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E5" events="15" subjects_affected="15" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="130"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="89"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="132"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="130"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="89"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="132"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="360"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="130"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="89"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="132"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="360"/>
              </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="4" subjects_affected="4" subjects_at_risk="130"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="89"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="132"/>
                <counts group_id="E4" events="8" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="130"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="89"/>
                <counts group_id="E3" events="14" subjects_affected="14" subjects_at_risk="132"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="360"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-La Roche</organization>
      <phone>800-821-8590</phone>
      <email>genentech@druginfo.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/NCT03289143
org study id: GN39763
secondary id: 2017-001800-31
nct id: NCT03289143
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This was a phase II, randomized, placebo-controlled, double-blind study to evaluate the
      efficacy and safety of Semorinemab in participants with prodromal to mild Alzheimer's
      disease. An optional 96-week open-label extension period was available to participants who
      completed the double-blind treatment period and who, in the judgment of the investigator,
      would potentially benefit from open-label Semorinemab treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Additional blinded personnel will include study site personnel who will evaluate participant status, contract research organization (CRO) personnel who will review case report forms (CRFs), and other sponsor agents (with the exception of the interactive voice or web-based response system [IxRS] vendor).
measure: Change From Baseline on the CDR-SB
time frame: Baseline and 73 Weeks
description: The Clinical Dementia Rating-Sum of Boxes (CDR-SB) rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment = 0, questionable impairment = 0.5 and mild, moderate and severe impairment = 1, 2 and 3 respectively. The score range is from 0 to 18 with a high score indicating a high disease severity. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.
measure: Percentage of Participants With Adverse Events
time frame: Up to the data cutoff date 15 January 2021 (up to approximately 39 months)
description: Percentage of participants with at least one adverse event
measure: Change From Baseline on the C-SSRS
time frame: Baseline to data cutoff date 15 January 2021 (up to approximately 39 months)
description: Categories are as defined in the Classification Algorithm for Suicide Assessment (CASA) based on the Columbia Suicide Severity Rating Scale (C-SSRS) questionnaire. SI1: Passive category is "Wish to be dead", SI2: Active-Nonspecific (no method, intent or plan), SI3: Active-Method, but no intent or Plan, SI4: Active-Method and intent, but no plan in C-SSRS. The worst post-baseline suicidal ideation is the highest across post-baseline visits, with highest as SI5 and lowest as SI1. Percentages are based on the total number of subjects in a treatment group. Baseline is the last observation prior to initiation of study drug.
measure: Other Abnormal MRI Findings
time frame: Baseline, Week 9, Week 49, Week 73, Study Treatment Discontinuation, and Week 89
description: Other abnormal MRI findings by visit. For the Double Blind Period, baseline is defined as last results prior to initiation of study drug. For the Open Label Extension Period, baseline is defined as last results prior to entering the open label period.
measure: Change From Baseline on the Repeatable Battery for Assessment of Neuropsychological Status (RBANS)
time frame: Baseline and 73 weeks
description: The RBANS is a validated neuropsychological assessment has been shown to be a useful tool in both clinical and research settings. The RBANS consists of ten subtests that are combined to provide five indices, one for each of the five domains tested (immediate memory, visuospatial/constructional, language, attention, and delayed memory). Scores range from 40 to 160 and a higher score indicates better cognitive functioning. A decrease in the outcome measure from baseline corresponds to disease worsening. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.
measure: Change From Baseline on the Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog-13) Subscale Score
time frame: Baseline and 73 weeks
description: The ADAS-Cog-13 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The ADAS-Cog-13 is the ADAS-Cog-11 with 2 further items: delayed word recall and total digit cancellation. The score range for ADAS-Cog-13 is from 0 to 85 with high scores representing severe dysfunction. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.
measure: Change From Baseline on the Amsterdam Instrumental Activity of Daily Living (iADL) Questionnaire
time frame: Baseline and 73 weeks
description: The Amsterdam iADL questionnaire is an informant-based instrument for measuring iADL problems in participants with dementia. This instrument consists of 70 items, scored on a 5-point scale, that uses item response theory for scoring. Items presented to the informant are tailored to responses to earlier items; thus each administration of the Amsterdam iADL may consist of less than the total of 70 items. The resulting score ranges from 20 to 80 with lower scores indicating poorer performance. A decrease in the outcome measure from baseline corresponds to disease worsening. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.
measure: Change From Baseline on the Alzheimer's Disease Cooperative Study Group-Activities of Daily Living Inventory
time frame: Baseline and 73 weeks
description: The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is the scale most widely used to assess functional outcomes in participants with AD. The ADCS-ADL covers both basic ADL (e.g., eating and toileting) and more complex 'instrumental' ADL or iADL (e.g., using the telephone, managing finances and preparing a meal). The ADCS-ADL consists of 23 questions with a score range of 0 to 78 where a higher score represents better function. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.
measure: Serum Concentrations of Semorinemab at Specified Timepoints
time frame: Up to 109 weeks
description: Serum concentrations of Semorinemab at specified timepoints.
measure: Presence of Anti-drug Antibodies During the Study Relative to Their Presence at Baseline
time frame: Up to 109 weeks
description: Presence of anti-drug antibodies during the study relative to their presence at baseline.
arm group label: Dose 1 Semorinemab
arm group type: Experimental
arm group label: Dose 2 Semorinemab
arm group type: Experimental
arm group label: Dose 3 Semorinemab
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Semorinemab
description: Participants will receive Semorinemab intravenously (IV).
arm group label: Dose 1 Semorinemab
arm group label: Dose 2 Semorinemab
arm group label: Dose 3 Semorinemab
other name: RG6100
other name: MTAU9937A
other name: RO7105705
intervention type: Drug
intervention name: Placebo
description: Matching placebo doses of Semorinemab given intravenously (IV).
arm group label: Placebo
intervention type: Drug
intervention name: [18F]GTP1
description: [18F]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.
arm group label: Dose 1 Semorinemab
arm group label: Dose 2 Semorinemab
arm group label: Dose 3 Semorinemab
arm group label: Placebo
other name: RO6880276
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Genentech, Inc.
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country: Australia
country: Belgium
country: Canada
country: Denmark
country: France
country: Germany
country: Italy
country: Netherlands
country: Poland
country: Spain
country: Sweden
country: United Kingdom
country: United States
country: Finland
responsible party type: Sponsor
mesh term: Alzheimer Disease
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