<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/NCT02245737</url>
  </required_header>
  <id_info>
    <org_study_id>16023</org_study_id>
    <secondary_id>I8D-MC-AZES</secondary_id>
    <secondary_id>2014-002601-38</secondary_id>
    <secondary_id>D5010C00009</secondary_id>
    <nct_id>NCT02245737</nct_id>
  </id_info>
  <brief_title>An Efficacy and Safety Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease</brief_title>
  <acronym>AMARANTH</acronym>
  <official_title>A 24-month, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy, Safety, Tolerability, Biomarker, and Pharmacokinetic Study of AZD3293 in Early Alzheimer's Disease (The AMARANTH Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy and safety of lanabecestat compared with&#xD;
      placebo administered for 104 weeks in the treatment of early Alzheimer´s disease. The study&#xD;
      will test the hypothesis that lanabecestat is a disease-modifying treatment for participants&#xD;
      with early Alzheimer´s disease, defined as the continuum of participants with mild cognitive&#xD;
      impairment (MCI) due to Alzheimer´s disease and participants diagnosed with mild dementia of&#xD;
      the Alzheimer´s type, as measured by change from baseline on the 13-item Alzheimer's Disease&#xD;
      Assessment Scale - Cognitive Subscale (ADAS-Cog13) score at week 104 in each of the 2&#xD;
      lanabecestat treatment groups compared with placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants who meet other study entry requirements will be required to undergo either an&#xD;
      amyloid positron emission tomography (PET) scan or a lumbar puncture for cerebrospinal fluid&#xD;
      (CSF) sampling at screening to document presence of abnormal levels of brain and CSF amyloid&#xD;
      for study inclusion. The study includes 2 sub-studies: the participants that undergo a PET&#xD;
      scan at screening will be included in the PET-substudy, and participants who undergo a lumbar&#xD;
      puncture at screening will be included in the CSF substudy until each of these substudies are&#xD;
      completed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    An independent assessment concluded the trial was not likely to meet the primary endpoint upon&#xD;
    completion and therefore, trial stopped for futility&#xD;
  </why_stopped>
  <start_date type="Actual">September 30, 2014</start_date>
  <completion_date type="Actual">October 4, 2018</completion_date>
  <primary_completion_date type="Actual">October 4, 2018</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)</measure>
    <time_frame>Baseline, Week 104</time_frame>
    <description>ADAS-Cog13 (13-item version of ADAS-Cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, pooled country, and covariates for baseline ADAS-Cog13 total score, age at baseline, and baseline ADAS-Cog13 total score-by-visit interaction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)</measure>
    <time_frame>Baseline, Week 104</time_frame>
    <description>The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean was determined by MMRM model with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline for baseline iADL score, age at baseline, and baseline iADL score-by-visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on the Functional Activities Questionnaire (FAQ) Score</measure>
    <time_frame>Baseline, Week 104</time_frame>
    <description>FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from writing checks, assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did [the activity] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3). FAQ scale is 0 to 30, with higher scores indicating greater impairment. LS Mean was calculated by MMRM with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline and pooled country.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score</measure>
    <time_frame>Baseline, Week 104</time_frame>
    <description>The iADRS is a composite that measures both cognition and function. The iADRS comprises scores form the ADAS- Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 (score range 0 to 85 with higher scores reflecting worse performance) and the ADCS-iADL (score range from 0-59 with higher scores reflecting better performance). The iADRS score ranges from 0 to 144 with higher scores indicating greater impairment. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by- visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline iADRS13 total score, age at baseline, and baseline iADRS13 total score-by-visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score</measure>
    <time_frame>Baseline, Week 104</time_frame>
    <description>The CDR-SB is a rater administered scale and impairment is scored in of the following categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which no dementia = 0, questionable dementia = 0.5, mild dementia = 1, moderate dementia = 2 and severe dementia = 3. The 6 individual category ratings, or &quot;box scores&quot;, were added together to give the CDR-Sum of Boxes which ranges from 0-18, with higher scores indicating greater impairment. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline CDR-SB score, age at baseline, and baseline CDR-SB score-by-visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage</measure>
    <time_frame>Baseline through Loss of 1 Global Stage or Week 104</time_frame>
    <description>The CDR global score is a composite score calculated using the Washington University CDR-assignment algorithm applied to the 6 individual domain box scores (Morris 1993). The memory domain is considered the primary category that drives the CDR global outcome, and all other domains are secondary. The CDR global score ranges from 0 to 3 (0 = no dementia, 0.5 = questionable dementia, 1 = mild dementia, 2 = moderate dementia, 3 = severe dementia).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Neuropsychiatric Inventory (NPI) Score</measure>
    <time_frame>Baseline, Week 104</time_frame>
    <description>The NPI is a questionnaire administered to caregivers that quantifies behavioral changes. Each of the 12 behavioral domains the caregiver reports as present are scored for Frequency, scale: 1 (Occasionally) to 4 (Very Frequently), and Severity, scale: 1 (Mild) to 3 (Severe). If the domain is reported by the caregiver as 'Not Affected,' that domain is scored as 0. The individual domain scores are calculated by multiplying the frequency times the severity for each domain. NPI Total Score is calculated by adding the individual domain scores together for all 12 domains, with a scores range from 0 to 144, with higher scores indicating greater severity of neuropsychiatric disturbance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline NPI score, age at baseline, and baseline NPI score-by-visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on the Mini-Mental State Examination (MMSE)</measure>
    <time_frame>Baseline, Week 104</time_frame>
    <description>The MMSE is an instrument used to assess a participant's global cognitive function. The MMSE assesses orientation to time and place, immediate and delayed recall of words, attention and calculation, language (naming, comprehension and repetition), and spatial ability (copying a figure). The range for MMSE total Score is 0 to 30, with a higher score indicating better cognitive performance. LS mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline MMSE total score, age at baseline, and baseline MMSE total score-by-visit interaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics (PD): Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aβ)1-42</measure>
    <time_frame>Baseline, Week 97</time_frame>
    <description>Concentration of the peptide Aβ 1-42 in plasma measured by validated immunoassay. LS Mean was determined by Analysis of covariance (ANCOVA) with last observation carried forward (LOCF), terms for treatment, baseline biomarker and age at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PD: Percent Change From Baseline in Concentration of CSF Biomarker Aβ1-40</measure>
    <time_frame>Baseline, Week 97</time_frame>
    <description>Concentration of the peptide Aβ 1-40 in plasma measured by immunoassay. LS Mean was determined by ANCOVA with LOCF (last observation carried forward), terms for treatment, baseline biomarker and age at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CSF Total Tau</measure>
    <time_frame>Baseline, Week 97</time_frame>
    <description>Cerebrospinal fluid samples are collected for analysis of concentration total tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CSF Phosphorylated Tau</measure>
    <time_frame>Baseline, Week 97</time_frame>
    <description>Cerebrospinal fluid samples are collected for analysis of concentrations of phosphorylated tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Brain Amyloid Burden Using Florbetapir Amyloid Positron Emission Tomography (PET) Scan</measure>
    <time_frame>Baseline, Week 104</time_frame>
    <description>Amyloid deposition in the brain is one of the defining neuropathologic findings of Alzheimer's disease. Florbetapir exhibits high affinity specific binding to amyloid plaques. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by florbetapir amyloid PET imaging in a subset of participants. The Centiloid scale standardizes quantitative brain amyloid PET results to allow cross-tracer and cross-methodology comparisons. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scans. Florbetapir SUVr was converted to the Centiloid scale using the following conversion: Florbetapir Centiloids = 183 x SUVr - 177. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Tau PET ((Flortaucipir F18)</measure>
    <time_frame>Baseline, Week 104</time_frame>
    <description>Tau PET tracer (flortaucipir F18) longitudinal study measured whether lanabecestat, in participants with mild AD dementia, affected tau density and distribution over time. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the signal intensity in white matter. Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline. Baseline defined to be within 28 days of starting study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Brain Metabolism Using Fluorodeoxyglucose (FDG)</measure>
    <time_frame>Baseline, Week 104</time_frame>
    <description>Fluorodeoxyglucose (FDG) PET evaluates the regional brain metabolic rates for glucose as a sensitive, in vivo metabolic index of brain function. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the pons + vermis assessed with composite meta and composite meta automated anatomical labeling atlas (ALL). Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline. Baseline defined to be within 28 days of starting study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Whole Brain Volume</measure>
    <time_frame>Baseline, Week 104</time_frame>
    <description>Magnetic resonance imaging (MRI) was used to evaluate the effect of lanabecestat on whole brain volumes. Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, baseline vMRI, intracranial volume, disease status at baseline and age at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Plasma Concentration of Lanabecestat</measure>
    <time_frame>Week 4, post dose prior to departure from the clinic</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">2218</enrollment>
  <condition>Alzheimer´s Disease</condition>
  <arm_group>
    <arm_group_label>Lanabecestat 20 milligrams (mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lanabecestat 20 mg given orally once daily for 104 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lanabecestat 50 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lanabecestat 50 mg given orally once daily for 104 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo given orally once daily for 104 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lanabecestat</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Lanabecestat 20 milligrams (mg)</arm_group_label>
    <arm_group_label>Lanabecestat 50 mg</arm_group_label>
    <other_name>LY3314814</other_name>
    <other_name>AZD3293</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gradual and progressive change in the participant's memory function over more than 6&#xD;
             months, reported by participant and study partner&#xD;
&#xD;
          -  Mini-Mental State Examination score of 20-30 inclusive at screening&#xD;
&#xD;
          -  Objective impairment in memory as evaluated by memory test performed at screening&#xD;
&#xD;
          -  For a diagnosis of mild Alzheimer's Disease (AD), participant meets the National&#xD;
             Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable AD&#xD;
&#xD;
          -  For a diagnosis of MCI due to AD, participant meets NIA-AA criteria for MCI due to AD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant neurological disease affecting the central nervous system, other than AD,&#xD;
             that may affect cognition or ability to complete the study, including but not limited&#xD;
             to, other dementias, serious infection of the brain, Parkinson´s disease, or epilepsy&#xD;
             or recurrent seizures&#xD;
&#xD;
          -  History of clinically evident stroke, or multiple strokes based on history or imaging&#xD;
             results&#xD;
&#xD;
          -  History of clinically important carotid or vertebrobasilar stenosis or plaque&#xD;
&#xD;
          -  History of multiple concussions with sustained cognitive complaints or objective&#xD;
             change in neuropsychological function in the last 5 years&#xD;
&#xD;
          -  Participants with a current Diagnostic and Statistical Manual of Mental Disorders,&#xD;
             Fifth Edition diagnosis of Major Depressive Disorder or any current primary&#xD;
             psychiatric diagnosis other than AD if, in the judgment of the investigator, the&#xD;
             psychiatric disorder or symptom is likely to confound interpretation of drug effect,&#xD;
             affect cognitive assessments, or affect the participant´s ability to complete the&#xD;
             study&#xD;
&#xD;
          -  History of alcohol or drug abuse or dependence (except nicotine dependence) within 2&#xD;
             years before the screening&#xD;
&#xD;
          -  Within 1 year before the screening or between screening and baseline, any of the&#xD;
             following: myocardial infarction; moderate or severe congestive heart failure, New&#xD;
             York Heart Association class III or IV; hospitalization for, or symptom of, unstable&#xD;
             angina; syncope due to orthostatic hypotension or unexplained syncope; known&#xD;
             significant structural heart disease (eg, significant valvular disease, hypertrophic&#xD;
             cardiomyopathy), or hospitalization for arrhythmia&#xD;
&#xD;
          -  Congenital QT prolongation&#xD;
&#xD;
          -  History of cancer within the last 5 years, with the exception of non-metastatic basal&#xD;
             and/or squamous cell carcinoma of the skin, in situ cervical cancer, non-progressive&#xD;
             prostate cancer or other cancers with low-risk of recurrence or spread&#xD;
&#xD;
          -  Current serious or unstable clinically important systemic illness that, in the&#xD;
             judgment of the investigator, is likely to affect cognitive assessment, deteriorate,&#xD;
             or affect the participant's safety or ability to complete the study, including&#xD;
             hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic,&#xD;
             immunologic, or hematologic disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon- Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner Alzheimer's Institute</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Josephs Hospital and Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Banner Sun Health Research Institute</name>
      <address>
        <city>Sun City</city>
        <state>Arizona</state>
        <zip>85351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Territory Neurology &amp; Research Institute</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Positron Research International</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance Research Centers</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Senior Clinical Trials, Inc.</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Collaborative Neuroscience Network - CNS</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Research Network Inc</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Francisco Clinical Research Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mile High Research Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Neurodegenerative Disorders</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgetown University Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brain Matters Research</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33445</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Direct Helpers Medical Center</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Berma Research</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galiz Research</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MaxBlue Institute</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alzheimer's Research and Treatment Center</name>
      <address>
        <city>Lake Worth</city>
        <state>Florida</state>
        <zip>33449</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>Medical Research Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allied Biomedical Research Institute, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advance Medical Research Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Horizon Research Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33175</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JDH Medical Group, LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33186</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compass Research</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IMIC, Inc.</name>
      <address>
        <city>Palmetto Bay</city>
        <state>Florida</state>
        <zip>33157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suncoast Neuroscience Associates</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roskamp Institute</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infinity Clinical Research, LLC</name>
      <address>
        <city>Sunrise</city>
        <state>Florida</state>
        <zip>33351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stedman Clinical Trials</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Olympian Clinical Research</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compass Research</name>
      <address>
        <city>The Villages</city>
        <state>Florida</state>
        <zip>32162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premiere Research Institute at Palm Beach Neurology</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Multiple Sclerosis Center of Atlanta</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30327</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Center of Medical Research</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carman Research</name>
      <address>
        <city>Smyrna</city>
        <state>Georgia</state>
        <zip>30080</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alexian Brothers Medical Center</name>
      <address>
        <city>Elk Grove Village</city>
        <state>Illinois</state>
        <zip>60007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Clinical Research Center</name>
      <address>
        <city>Anderson</city>
        <state>Indiana</state>
        <zip>46011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University School of Medicine</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ActivMed Practices &amp; Research, Inc</name>
      <address>
        <city>Methuen</city>
        <state>Massachusetts</state>
        <zip>01844</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Center for Memory</name>
      <address>
        <city>Newton</city>
        <state>Massachusetts</state>
        <zip>02459</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Springfield Neurology Associates</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hattiesburg Clinic</name>
      <address>
        <city>Hattiesburg</city>
        <state>Mississippi</state>
        <zip>39401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Millennium Psychiatric Associates, LLV</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis Clinical Trials, LC</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memory Enhancement Center of America, Inc.</name>
      <address>
        <city>Eatontown</city>
        <state>New Jersey</state>
        <zip>07724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AdvanceMed Research</name>
      <address>
        <city>Lawrenceville</city>
        <state>New Jersey</state>
        <zip>08648</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alzheimer's Research Company</name>
      <address>
        <city>Manchester</city>
        <state>New Jersey</state>
        <zip>08759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cognitive and Research Center of NJ</name>
      <address>
        <city>Springfield</city>
        <state>New Jersey</state>
        <zip>07081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Memory Research Institute of New Jersey</name>
      <address>
        <city>Toms River</city>
        <state>New Jersey</state>
        <zip>08755</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bio Behavioral Health</name>
      <address>
        <city>Toms River</city>
        <state>New Jersey</state>
        <zip>08755</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurology Specialists of Monmouth County</name>
      <address>
        <city>West Long Branch</city>
        <state>New Jersey</state>
        <zip>07764</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Integrative Clinical Trials, LLC</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPRI Clinical Trials, LLC.</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alzheimer's Disease and Memory Disorders Center</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Empire Neurology, PC</name>
      <address>
        <city>Latham</city>
        <state>New York</state>
        <zip>12110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinilabs, Inc (New York)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University 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</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alzheimer's Memory Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28270</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Medical Primary Care</name>
      <address>
        <city>Centerville</city>
        <state>Ohio</state>
        <zip>45459</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christ Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Corvallis Clinic P.C.</name>
      <address>
        <city>Corvallis</city>
        <state>Oregon</state>
        <zip>97330</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Lehigh Valley Hospital</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</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>
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  <location>
    <facility>
      <name>Roper St. Francis Healthcare</name>
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        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29651</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Quillen College of Medicine, East TN State University</name>
      <address>
        <city>Johnson City</city>
        <state>Tennessee</state>
        <zip>37605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Senior Adults Specialty Research Inc</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78757</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Health Physicians Group</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Group of Texas</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Services Center - Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah School of Medicine</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Memory Clinic</name>
      <address>
        <city>Bennington</city>
        <state>Vermont</state>
        <zip>05201</zip>
        <country>United States</country>
      </address>
    </facility>
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  <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>Griffith University</name>
      <address>
        <city>Gold Coast</city>
        <state>Queensland</state>
        <zip>4222</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Box Hill Hospital</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delmont Private Hospital</name>
      <address>
        <city>Glen Iris</city>
        <state>Victoria</state>
        <zip>3146</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heidelberg Repatriation Hospital</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3081</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Florey Institute of Neuroscience and Mental Health</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Australian Alzheimer's Research Foundation</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Neuro Trials Victoria Pty Ltd</name>
      <address>
        <city>Noble Park</city>
        <zip>3174</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jessa Ziekenhuis</name>
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        <city>Hasselt</city>
        <state>Limburg</state>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Hopital Universitaire Brugmann Brussel</name>
      <address>
        <city>Brussels</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires Saint-Luc</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitaire Erasme Brussel</name>
      <address>
        <city>Brussel</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Antwerpen</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heilig Hartziekenhuis</name>
      <address>
        <city>Roeselare</city>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Medical Arts Health Research Group</name>
      <address>
        <city>Kamloops</city>
        <state>British Columbia</state>
        <zip>V2C 1K7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okanagan Clinical Trials</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y 1Z9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of British Columbia</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6T 2B5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Jubilee Hospital</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8R 158</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>True North Clinical Research Halifax, LLC</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3S1M7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bruyere Continuing Care</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1N 5C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kawartha Regional Memory Clinic</name>
      <address>
        <city>Peterborough</city>
        <state>Ontario</state>
        <zip>K9H2P4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Memory Program</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M3B2S7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Western Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CSSS-Institut Universitaire Gériatric de Sherbrooke</name>
      <address>
        <city>Sherbrooke</city>
        <state>Qubec</state>
        <zip>J1J3H5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique de la Memoire de l'Outaouais</name>
      <address>
        <city>Gatineau</city>
        <state>Quebec</state>
        <zip>J8T 8J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NeuroSearch Developements</name>
      <address>
        <city>Greenfield Park</city>
        <state>Quebec</state>
        <zip>J4V 2J2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Maisonneure-Rosemount</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de L'Enfant Jesus</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G1J 1Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Q&amp;T Research Sherbrooke Inc</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1J 2G2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Toulouse Hopital Purpan</name>
      <address>
        <city>Toulouse</city>
        <state>Cedex 9</state>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Neuro Pierre Wertheimer</name>
      <address>
        <city>Bron Cedex</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Dijonon</name>
      <address>
        <city>Dijon Cedex</city>
        <zip>21033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Lille - Hopital Roger Salengro</name>
      <address>
        <city>Lille Cedex</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Hopital de la Timone</name>
      <address>
        <city>Marseille Cedex 05</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu de Nantes Hopital Laennec</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Broca</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de la Pitie Salpetriere</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Lariboisière</name>
      <address>
        <city>Paris</city>
        <zip>75475</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31052</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>Universitätsklinikum Tübingen</name>
      <address>
        <city>Tübingen</city>
        <state>Baden-Württemberg</state>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <state>Baden-Württemberg</state>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Studien und Gedächtniszentrum München</name>
      <address>
        <city>München</city>
        <state>Bayern</state>
        <zip>80331</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Rechts der Isar der TU München</name>
      <address>
        <city>München</city>
        <state>Bayern</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut fur Psychogerontologie</name>
      <address>
        <city>Nürnberg</city>
        <state>Bayern</state>
        <zip>90402</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurozentrum Prien</name>
      <address>
        <city>Prien am Chiemsee</city>
        <state>Bayern</state>
        <zip>83209</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut für Neuropsychiatrie INP3</name>
      <address>
        <city>Wenzenbach</city>
        <state>Bayern</state>
        <zip>93173</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Studienzentrum Nord-West</name>
      <address>
        <city>Westerstede</city>
        <state>Niedersachsen</state>
        <zip>26655</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. Lauter</name>
      <address>
        <city>Bochum</city>
        <state>Nordrhein-Westfalen</state>
        <zip>44787</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Josef-Hospital Bochum</name>
      <address>
        <city>Bochum</city>
        <state>Nordrhein-Westfalen</state>
        <zip>44791</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Bonn</name>
      <address>
        <city>Bonn</city>
        <state>Nordrhein-Westfalen</state>
        <zip>53105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis für Neurologie Prof. Gereon Nelles</name>
      <address>
        <city>Köln</city>
        <state>Nordrhein-Westfalen</state>
        <zip>50935</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Köln</name>
      <address>
        <city>Köln</city>
        <state>Nordrhein-Westfalen</state>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurologische Praxis Siegen</name>
      <address>
        <city>Siegen</city>
        <state>Nordrhein-Westfalen</state>
        <zip>57076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum des Saarlandes</name>
      <address>
        <city>Homburg</city>
        <state>Saarland</state>
        <zip>66421</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Martin-Luther-Universität Halle-Wittenberg</name>
      <address>
        <city>Halle (Saale)</city>
        <state>Sachsen-Anhalt</state>
        <zip>06097</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Otto-von-Guericke-Universität</name>
      <address>
        <city>Magdeburg</city>
        <state>Sachsen-Anhalt</state>
        <zip>39120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmakologisches Studienzentrum Chemnitz</name>
      <address>
        <city>Mittweida</city>
        <state>Sachsen</state>
        <zip>09648</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arztpraxis Dr. Christian Oehlwein</name>
      <address>
        <city>Gera</city>
        <state>Thüringen</state>
        <zip>07551</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis Dr. R. Ehret &amp; Dr. W. von Pannwitz</name>
      <address>
        <city>Berlin</city>
        <zip>12163</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PTE KK Pszichiatriai es Pszichoterapias Klinika</name>
      <address>
        <city>Pecs</city>
        <state>Baranya</state>
        <zip>7623</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelweis Medical University</name>
      <address>
        <city>Budapest</city>
        <zip>1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Del-pesti Centrumkorház - Orszagos Hematologiai és Infektologiai Intezet</name>
      <address>
        <city>Budapest</city>
        <zip>1097</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz</name>
      <address>
        <city>Debrecen</city>
        <zip>4031</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Kozpont</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univerisity of Szeged</name>
      <address>
        <city>Szeged</city>
        <zip>6725</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Degli Infermi ASR USSL 12</name>
      <address>
        <city>Ponderano</city>
        <state>Biella</state>
        <zip>13875</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera San Gerardo</name>
      <address>
        <city>Monza</city>
        <state>Milano</state>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione San Raffaele Giglio di Cefalu</name>
      <address>
        <city>Cefalu</city>
        <state>Palermo</state>
        <zip>90015</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita Di Pisa</name>
      <address>
        <city>Pisa</city>
        <state>PI</state>
        <zip>56126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Università Politecnica delle Marche Torrette</name>
      <address>
        <city>Ancona</city>
        <zip>60126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS San Giovanni di Dio Fatebenefratelli</name>
      <address>
        <city>Brescia</city>
        <zip>25125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Universitaria degli Studi G D'Annunzio</name>
      <address>
        <city>Chieti</city>
        <zip>66100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ente Ospedaliero Ospedali Galliera</name>
      <address>
        <city>Genova</city>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Ca'Granda Ospedale Maggiore Policinico</name>
      <address>
        <city>Milano</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nuovo Ospedale Civile Sant'Agostino Estense</name>
      <address>
        <city>Modena</city>
        <zip>41010</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Univ. Agostino Gemelli</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza</name>
      <address>
        <city>Roma</city>
        <zip>00185</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Giovanni Calibita Fatebenefratelli</name>
      <address>
        <city>Roma</city>
        <zip>00186</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Ospedale S. Andrea</name>
      <address>
        <city>Roma</city>
        <zip>00189</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Citta della Salute della Scienza Torino</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Institute for Longevity Sciences NCGG</name>
      <address>
        <city>Obu</city>
        <state>Aichi</state>
        <zip>474-0038</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Chiba-East-Hospital</name>
      <address>
        <city>Chuo-ku</city>
        <state>Chiba</state>
        <zip>260-8712</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Asahikawa Medical Center</name>
      <address>
        <city>Asahikawa</city>
        <state>Hokkaido</state>
        <zip>070-8644</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tsukuba University Hospital</name>
      <address>
        <city>Tsukuba</city>
        <state>Ibaraki</state>
        <zip>305-8576</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iwate Medical University Hospital</name>
      <address>
        <city>Morioka</city>
        <state>Iwate</state>
        <zip>020-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shonan Kamakura General Hospital</name>
      <address>
        <city>Kamakura</city>
        <state>Kanagawa</state>
        <zip>247-8533</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nihon Kokan Hospital</name>
      <address>
        <city>Kawasaki</city>
        <state>Kanagawa</state>
        <zip>210-0852</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yokohama City University Hospital</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>236-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyoto Prefectural University of Medicine</name>
      <address>
        <city>Kyoto-shi</city>
        <state>Kyoto</state>
        <zip>602-8566</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rakuwakai Otowarehabilitation Hospital</name>
      <address>
        <city>Kyoto-shi</city>
        <state>Kyoto</state>
        <zip>607-8113</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ina Central Hospital</name>
      <address>
        <city>Ina</city>
        <state>Nagano</state>
        <zip>396-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Matsumoto Medical Center</name>
      <address>
        <city>Matsumoto</city>
        <state>Nagano</state>
        <zip>399-0021</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Katayama Medical Clinic</name>
      <address>
        <city>Kurashiki</city>
        <state>Okayama</state>
        <zip>701-0192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shiroma Clinic</name>
      <address>
        <city>Urasoe</city>
        <state>Okinawa</state>
        <zip>901-2102</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Koshokai aino hospital</name>
      <address>
        <city>Ibaraki</city>
        <state>Osaka</state>
        <zip>567-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sakaguchi Clinic</name>
      <address>
        <city>Sakai</city>
        <state>Osaka</state>
        <zip>593-8301</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Sanatorium Toneyama Hospital</name>
      <address>
        <city>Toyonaka</city>
        <state>Osaka</state>
        <zip>560-8552</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Medical University Hospital</name>
      <address>
        <city>Iruma-Gun</city>
        <state>Saitama</state>
        <zip>350-0495</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nippon Medical School Hospital</name>
      <address>
        <city>Bunkyo-Ku</city>
        <state>Tokyo</state>
        <zip>113-8603</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Tokyo Hospital</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-8655</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nozomi Memory Clinic</name>
      <address>
        <city>Mitaka-shi</city>
        <state>Tokyo</state>
        <zip>181-0013</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sangenjaya Nakamura Mental Clinic</name>
      <address>
        <city>Setagaya</city>
        <state>Tokyo</state>
        <zip>154-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanauchi Medical Clinic</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>160-0023</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Women's Medical University Hospital</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>162-8666</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memory Clinic Ochanomizu</name>
      <address>
        <city>Tsukuba</city>
        <state>Tokyo</state>
        <zip>305 8576</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Sanatorium Hokuriku Hospital</name>
      <address>
        <city>Nanto</city>
        <state>Toyama</state>
        <zip>939-1893</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuoka University Hospital</name>
      <address>
        <city>Fukuoka</city>
        <zip>814-0180</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyoto University Hospital</name>
      <address>
        <city>Kyoto</city>
        <zip>606-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyoto Minami Hospital</name>
      <address>
        <city>Kyoto</city>
        <zip>610-0113</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Utano Hospital</name>
      <address>
        <city>Kyoto</city>
        <zip>616-8255</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Osaka</city>
        <zip>545-8586</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dong-A University Medical Center</name>
      <address>
        <city>Seogu</city>
        <state>Busan</state>
        <zip>49201</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Geonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea-Bucheon St. Mary's Hospital</name>
      <address>
        <city>Bucheon-si</city>
        <state>Gyeonggi-do</state>
        <zip>14647</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hanyang University Guri Hospital</name>
      <address>
        <city>Guri-si</city>
        <state>Gyeonggido</state>
        <zip>11923</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center</name>
      <address>
        <city>Namdong</city>
        <state>Incheon</state>
        <zip>21565</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inha University Hospital</name>
      <address>
        <city>Incheon</city>
        <zip>22332</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Wroclawskie Centrum Alzheimerowskie</name>
      <address>
        <city>Wroclaw</city>
        <state>Dolnoslaskie</state>
        <zip>53 139</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medycyna Milorzab</name>
      <address>
        <city>Lodz</city>
        <state>Lódzkie</state>
        <zip>92216</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Podlaskie Centrum Psychogeriatrii</name>
      <address>
        <city>Białystok</city>
        <state>Podlaskie</state>
        <zip>15-732</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Dom Sue Ryder - Pallmed Sp. z o.o.</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-796</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Wielospecjalistyczna Poradnia Lekarska</name>
      <address>
        <city>Katowice</city>
        <zip>40-123</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala</name>
      <address>
        <city>Katowice</city>
        <zip>40-588</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Zdrowia Psychicznego</name>
      <address>
        <city>Kielce</city>
        <zip>25411</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Neurologii Klinicznej</name>
      <address>
        <city>Krakow</city>
        <zip>31-505</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Neuromed M. I M. Nastaj sp. P.</name>
      <address>
        <city>Lublin</city>
        <zip>20-064</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instytut Medycyny Wsi</name>
      <address>
        <city>Lublin</city>
        <zip>20-090</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>Centrum Medyczne</name>
      <address>
        <city>Warszawa</city>
        <zip>01-697</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centralny Szpital Kliniczny MSW</name>
      <address>
        <city>Warszawa</city>
        <zip>02-507</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Cruz Behavioral PSC</name>
      <address>
        <city>Bayamon</city>
        <zip>00961</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ivonne Z. Jimenez-Velazquez, MD</name>
      <address>
        <city>Carolina</city>
        <zip>00984</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Neurologia Dra. Ivonne Fraga</name>
      <address>
        <city>San Juan</city>
        <zip>00918</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michel A. Woodbury-Farina, MD.</name>
      <address>
        <city>San Juan</city>
        <zip>00918</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SC Med Life SA</name>
      <address>
        <city>Bucuresti</city>
        <zip>010719</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SC Centrul Medical Sana SRL</name>
      <address>
        <city>Bucuresti</city>
        <zip>011025</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinica CCBR S.R.L.</name>
      <address>
        <city>Bucuresti</city>
        <zip>30463</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SC Med Life SA</name>
      <address>
        <city>Timisoara</city>
        <zip>300166</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Elche</name>
      <address>
        <city>Elche</city>
        <state>Alicante</state>
        <zip>03203</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Catalunya</name>
      <address>
        <city>Sant Cugat del Valles</city>
        <state>Barcelona</state>
        <zip>08190</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen Del Puerto</name>
      <address>
        <city>Plasencia</city>
        <state>Caceres</state>
        <zip>10600</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario De Getafe</name>
      <address>
        <city>Madrid</city>
        <state>Getafe</state>
        <zip>28905</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Puerta De Hierro</name>
      <address>
        <city>Majadahonda</city>
        <state>Madrid</state>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Atencion Especializada (CAE) OROITU</name>
      <address>
        <city>Getxo</city>
        <state>Vizcaya</state>
        <zip>48993</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Creu I Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion ACE-Institut Catala de Neurociences Aplicades</name>
      <address>
        <city>Barcelona</city>
        <zip>08028</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de Bellvitge</name>
      <address>
        <city>Barcelona</city>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Reina Sofia</name>
      <address>
        <city>Cordoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital De La Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</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 Son Espases</name>
      <address>
        <city>Palma de Mallorca</city>
        <zip>07010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Univ Sant Joan de Reus, S.A.</name>
      <address>
        <city>Reus</city>
        <zip>43204</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion CITA Alzheimer</name>
      <address>
        <city>San Sebastian</city>
        <zip>20009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Doctor Peset</name>
      <address>
        <city>Valencia</city>
        <zip>46017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Fe de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Plymouth Hospitals NHS Trust</name>
      <address>
        <city>Plymouth</city>
        <state>Devon</state>
        <zip>PL6 8BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cognitive Treatment &amp; Research Unit</name>
      <address>
        <city>Crowborough</city>
        <state>East Sussex</state>
        <zip>TN6 1HB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Health NHS</name>
      <address>
        <city>Southampton</city>
        <state>Hampshire</state>
        <zip>SO30 3JB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MAC UK Neuroscience Ltd</name>
      <address>
        <city>Blackpool</city>
        <state>Lancs</state>
        <zip>FY20JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MAC Clinical Research</name>
      <address>
        <city>Stourton</city>
        <state>Leeds</state>
        <zip>LS10 1DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MAC Clinical Research</name>
      <address>
        <city>Cannock</city>
        <state>Staffordshire</state>
        <zip>WS11 0BN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West London Mental Health NHS Trust</name>
      <address>
        <city>Brentford</city>
        <zip>TW8 8DS</zip>
        <country>United Kingdom</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>Hammersmith Hospital</name>
      <address>
        <city>London</city>
        <zip>W12 0NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guildford Nuffield Hospital</name>
      <address>
        <city>London</city>
        <zip>W1G 9JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Re-Cognition Health Ltd</name>
      <address>
        <city>London</city>
        <zip>W1G 9RU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MAC Clinical Research</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9NQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Romania</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Argentina</country>
    <country>Czech Republic</country>
    <country>Sweden</country>
  </removed_countries>
  <link>
    <url>https://www.lillytrialguide.com/en-US/studies/mild-alzheimer-s-disease/AZES#?postal=</url>
    <description>Click here for more information about this study: An Efficacy and Safety Study of LY3314814 in Early Alzheimer's Disease</description>
  </link>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=16023&amp;amp;attachmentIdentifier=f8802097-b8c3-4396-ad08-8df8ca98325d&amp;amp;fileName=CSP_NCT02245737.pdf&amp;amp;versionIdentifier=</url>
    <description>CSP</description>
  </link>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=16023&amp;amp;attachmentIdentifier=5c8b319d-5e9f-4b1d-b366-d589b53774a8&amp;amp;fileName=SAP_NCT02245737.pdf&amp;amp;versionIdentifier=</url>
    <description>SAP</description>
  </link>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <results_first_submitted>June 11, 2019</results_first_submitted>
  <results_first_submitted_qc>July 15, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 6, 2019</results_first_posted>
  <last_update_submitted>November 19, 2019</last_update_submitted>
  <last_update_submitted_qc>November 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alzheimer's disease</keyword>
  <keyword>Dementia</keyword>
  <keyword>Brain Diseases</keyword>
  <keyword>Neurogenerative Diseases</keyword>
  <keyword>Central Nervous System Diseases</keyword>
  <keyword>Nervous System Diseases</keyword>
  <keyword>Mental Disorders</keyword>
  <keyword>Delirium, Dementia, Amnestic, Cognitive Disorders</keyword>
  <keyword>Tauopathies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.</ipd_time_frame>
    <ipd_access_criteria>A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://www.clinicalstudydatarequest.com/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 17, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT02245737/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 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT02245737/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received placebo film-coated oral tablets once daily.</description>
        </group>
        <group group_id="P2">
          <title>Lanabecestat 20 Milligrams (mg)</title>
          <description>Participants received lanabecestat 20 mg film-coated oral tablets once daily.</description>
        </group>
        <group group_id="P3">
          <title>Lanabecestat 50 mg</title>
          <description>Participants received lanabecestat 50 mg film-coated oral tablets once daily.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="740"/>
                <participants group_id="P2" count="739"/>
                <participants group_id="P3" count="739"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="738"/>
                <participants group_id="P2" count="736"/>
                <participants group_id="P3" count="735"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="187"/>
                <participants group_id="P2" count="184"/>
                <participants group_id="P3" count="168"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="553"/>
                <participants group_id="P2" count="555"/>
                <participants group_id="P3" count="571"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="33"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Condition Worsened</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Eligibility Criteria No Longer Met</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Initiation of Symptomatic AD medication</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other-determined by Investigator</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="41"/>
                <participants group_id="P3" count="44"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal due to Caregiver Circumstance</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="22"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="445"/>
                <participants group_id="P2" count="430"/>
                <participants group_id="P3" count="432"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received placebo film-coated oral tablets once daily.</description>
        </group>
        <group group_id="B2">
          <title>Lanabecestat 20 mg</title>
          <description>Participants received lanabecestat 20 mg film-coated oral tablets once daily.</description>
        </group>
        <group group_id="B3">
          <title>Lanabecestat 50 mg</title>
          <description>Participants received lanabecestat 50 mg film-coated oral tablets once daily.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="740"/>
            <count group_id="B2" value="739"/>
            <count group_id="B3" value="739"/>
            <count group_id="B4" value="2218"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71.4" spread="6.9"/>
                    <measurement group_id="B2" value="71.2" spread="7.5"/>
                    <measurement group_id="B3" value="71.2" spread="7.0"/>
                    <measurement group_id="B4" value="71.3" spread="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="398"/>
                    <measurement group_id="B2" value="395"/>
                    <measurement group_id="B3" value="384"/>
                    <measurement group_id="B4" value="1177"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="342"/>
                    <measurement group_id="B2" value="344"/>
                    <measurement group_id="B3" value="355"/>
                    <measurement group_id="B4" value="1041"/>
                  </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="43"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="93"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="626"/>
                    <measurement group_id="B2" value="650"/>
                    <measurement group_id="B3" value="644"/>
                    <measurement group_id="B4" value="1920"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="71"/>
                    <measurement group_id="B4" value="205"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="102"/>
                    <measurement group_id="B4" value="272"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="598"/>
                    <measurement group_id="B2" value="609"/>
                    <measurement group_id="B3" value="593"/>
                    <measurement group_id="B4" value="1800"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Puerto Rico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Romania</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="171"/>
                    <measurement group_id="B2" value="171"/>
                    <measurement group_id="B3" value="179"/>
                    <measurement group_id="B4" value="521"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="78"/>
                    <measurement group_id="B4" value="183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="78"/>
                    <measurement group_id="B4" value="250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="65"/>
                    <measurement group_id="B4" value="216"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="63"/>
                    <measurement group_id="B4" value="180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Korea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="50"/>
                    <measurement group_id="B4" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="49"/>
                    <measurement group_id="B4" value="132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="52"/>
                    <measurement group_id="B4" value="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ADAS-Cog13 (13-item Alzheimer's Disease Assessment Scale)</title>
          <description>ADAS-Cog13, a 13-item rating scale, measured the severity of cognitive dysfunction in persons with Alzheimer's disease (AD). Scores ranged from 0 to 85, with a higher score indicating worse cognitive functioning.</description>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.6" spread="7.9"/>
                    <measurement group_id="B2" value="29.0" spread="7.7"/>
                    <measurement group_id="B3" value="28.5" spread="8.2"/>
                    <measurement group_id="B4" value="28.7" spread="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)</title>
        <description>ADAS-Cog13 (13-item version of ADAS-Cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, pooled country, and covariates for baseline ADAS-Cog13 total score, age at baseline, and baseline ADAS-Cog13 total score-by-visit interaction.</description>
        <time_frame>Baseline, Week 104</time_frame>
        <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADAS-Cog13 measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O2">
            <title>Lanabecestat 20 mg</title>
            <description>Participants received lanabecestat 20 mg film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O3">
            <title>Lanabecestat 50 mg</title>
            <description>Participants received lanabecestat 50 mg film-coated oral tablets once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)</title>
          <description>ADAS-Cog13 (13-item version of ADAS-Cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, pooled country, and covariates for baseline ADAS-Cog13 total score, age at baseline, and baseline ADAS-Cog13 total score-by-visit interaction.</description>
          <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADAS-Cog13 measure.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="723"/>
                <count group_id="O2" value="722"/>
                <count group_id="O3" value="708"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.31" spread="0.55"/>
                    <measurement group_id="O2" value="9.38" spread="0.56"/>
                    <measurement group_id="O3" value="10.72" spread="0.58"/>
                  </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>0.232</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-0.93</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.77</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.447</ci_lower_limit>
            <ci_upper_limit>0.594</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.599</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>0.41</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.78</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.124</ci_lower_limit>
            <ci_upper_limit>1.947</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)</title>
        <description>The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean was determined by MMRM model with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline for baseline iADL score, age at baseline, and baseline iADL score-by-visit interaction.</description>
        <time_frame>Baseline, Week 104</time_frame>
        <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADCS-iADL measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O2">
            <title>Lanabecestat 20 mg</title>
            <description>Participants received lanabecestat 20 mg film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O3">
            <title>Lanabecestat 50 mg</title>
            <description>Participants received lanabecestat 50 mg film-coated oral tablets once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)</title>
          <description>The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean was determined by MMRM model with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline for baseline iADL score, age at baseline, and baseline iADL score-by-visit interaction.</description>
          <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADCS-iADL measure.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="702"/>
                <count group_id="O2" value="700"/>
                <count group_id="O3" value="674"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.87" spread="0.60"/>
                    <measurement group_id="O2" value="-8.84" spread="0.61"/>
                    <measurement group_id="O3" value="-8.79" spread="0.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.971</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>0.03</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.83</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.609</ci_lower_limit>
            <ci_upper_limit>1.669</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.923</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>0.08</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.85</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.580</ci_lower_limit>
            <ci_upper_limit>1.743</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on the Functional Activities Questionnaire (FAQ) Score</title>
        <description>FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from writing checks, assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did [the activity] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3). FAQ scale is 0 to 30, with higher scores indicating greater impairment. LS Mean was calculated by MMRM with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline and pooled country.</description>
        <time_frame>Baseline, Week 104</time_frame>
        <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for FAQ score.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O2">
            <title>Lanabecestat 20 mg</title>
            <description>Participants received lanabecestat 20 mg film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O3">
            <title>Lanabecestat 50 mg</title>
            <description>Participants received lanabecestat 50 mg film-coated oral tablets once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the Functional Activities Questionnaire (FAQ) Score</title>
          <description>FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from writing checks, assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did [the activity] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3). FAQ scale is 0 to 30, with higher scores indicating greater impairment. LS Mean was calculated by MMRM with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline and pooled country.</description>
          <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for FAQ score.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="699"/>
                <count group_id="O2" value="697"/>
                <count group_id="O3" value="674"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.09" spread="0.38"/>
                    <measurement group_id="O2" value="5.96" spread="0.39"/>
                    <measurement group_id="O3" value="6.71" spread="0.40"/>
                  </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>0.796</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-0.14</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.53</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.172</ci_lower_limit>
            <ci_upper_limit>0.899</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.252</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>0.61</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.53</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.437</ci_lower_limit>
            <ci_upper_limit>1.660</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score</title>
        <description>The iADRS is a composite that measures both cognition and function. The iADRS comprises scores form the ADAS- Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 (score range 0 to 85 with higher scores reflecting worse performance) and the ADCS-iADL (score range from 0-59 with higher scores reflecting better performance). The iADRS score ranges from 0 to 144 with higher scores indicating greater impairment. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by- visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline iADRS13 total score, age at baseline, and baseline iADRS13 total score-by-visit interaction.</description>
        <time_frame>Baseline, Week 104</time_frame>
        <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for iADRS.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O2">
            <title>Lanabecestat 20 mg</title>
            <description>Participants received lanabecestat 20 mg film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O3">
            <title>Lanabecestat 50 mg</title>
            <description>Participants received lanabecestat 50 mg film-coated oral tablets once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score</title>
          <description>The iADRS is a composite that measures both cognition and function. The iADRS comprises scores form the ADAS- Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 (score range 0 to 85 with higher scores reflecting worse performance) and the ADCS-iADL (score range from 0-59 with higher scores reflecting better performance). The iADRS score ranges from 0 to 144 with higher scores indicating greater impairment. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by- visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline iADRS13 total score, age at baseline, and baseline iADRS13 total score-by-visit interaction.</description>
          <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for iADRS.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="696"/>
                <count group_id="O2" value="689"/>
                <count group_id="O3" value="662"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.56" spread="0.99"/>
                    <measurement group_id="O2" value="-18.45" spread="1.02"/>
                    <measurement group_id="O3" value="-19.69" spread="1.05"/>
                  </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>0.428</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>1.11</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.40</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.637</ci_lower_limit>
            <ci_upper_limit>3.852</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.926</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-0.13</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.42</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.918</ci_lower_limit>
            <ci_upper_limit>2.655</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score</title>
        <description>The CDR-SB is a rater administered scale and impairment is scored in of the following categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which no dementia = 0, questionable dementia = 0.5, mild dementia = 1, moderate dementia = 2 and severe dementia = 3. The 6 individual category ratings, or &quot;box scores&quot;, were added together to give the CDR-Sum of Boxes which ranges from 0-18, with higher scores indicating greater impairment. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline CDR-SB score, age at baseline, and baseline CDR-SB score-by-visit interaction.</description>
        <time_frame>Baseline, Week 104</time_frame>
        <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for CDR-SB.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O2">
            <title>Lanabecestat 20 mg</title>
            <description>Participants received lanabecestat 20 mg film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O3">
            <title>Lanabecestat 50 mg</title>
            <description>Participants received lanabecestat 50 mg film-coated oral tablets once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score</title>
          <description>The CDR-SB is a rater administered scale and impairment is scored in of the following categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which no dementia = 0, questionable dementia = 0.5, mild dementia = 1, moderate dementia = 2 and severe dementia = 3. The 6 individual category ratings, or &quot;box scores&quot;, were added together to give the CDR-Sum of Boxes which ranges from 0-18, with higher scores indicating greater impairment. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline CDR-SB score, age at baseline, and baseline CDR-SB score-by-visit interaction.</description>
          <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for CDR-SB.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="704"/>
                <count group_id="O2" value="705"/>
                <count group_id="O3" value="676"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.02" spread="0.17"/>
                    <measurement group_id="O2" value="3.17" spread="0.17"/>
                    <measurement group_id="O3" value="3.17" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.533</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>0.15</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.24</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.322</ci_lower_limit>
            <ci_upper_limit>0.622</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.537</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>0.15</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.24</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.328</ci_lower_limit>
            <ci_upper_limit>0.630</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage</title>
        <description>The CDR global score is a composite score calculated using the Washington University CDR-assignment algorithm applied to the 6 individual domain box scores (Morris 1993). The memory domain is considered the primary category that drives the CDR global outcome, and all other domains are secondary. The CDR global score ranges from 0 to 3 (0 = no dementia, 0.5 = questionable dementia, 1 = mild dementia, 2 = moderate dementia, 3 = severe dementia).</description>
        <time_frame>Baseline through Loss of 1 Global Stage or Week 104</time_frame>
        <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for CDR Global Score.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O2">
            <title>Lanabecestat 20 mg</title>
            <description>Participants received lanabecestat 20 mg film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O3">
            <title>Lanabecestat 50 mg</title>
            <description>Participants received lanabecestat 50 mg film-coated oral tablets once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage</title>
          <description>The CDR global score is a composite score calculated using the Washington University CDR-assignment algorithm applied to the 6 individual domain box scores (Morris 1993). The memory domain is considered the primary category that drives the CDR global outcome, and all other domains are secondary. The CDR global score ranges from 0 to 3 (0 = no dementia, 0.5 = questionable dementia, 1 = mild dementia, 2 = moderate dementia, 3 = severe dementia).</description>
          <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for CDR Global Score.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="716"/>
                <count group_id="O2" value="714"/>
                <count group_id="O3" value="696"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="548" lower_limit="547" upper_limit="554"/>
                    <measurement group_id="O2" value="547" lower_limit="545" upper_limit="550"/>
                    <measurement group_id="O3" value="548" lower_limit="545" upper_limit="553"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Neuropsychiatric Inventory (NPI) Score</title>
        <description>The NPI is a questionnaire administered to caregivers that quantifies behavioral changes. Each of the 12 behavioral domains the caregiver reports as present are scored for Frequency, scale: 1 (Occasionally) to 4 (Very Frequently), and Severity, scale: 1 (Mild) to 3 (Severe). If the domain is reported by the caregiver as 'Not Affected,' that domain is scored as 0. The individual domain scores are calculated by multiplying the frequency times the severity for each domain. NPI Total Score is calculated by adding the individual domain scores together for all 12 domains, with a scores range from 0 to 144, with higher scores indicating greater severity of neuropsychiatric disturbance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline NPI score, age at baseline, and baseline NPI score-by-visit interaction.</description>
        <time_frame>Baseline, Week 104</time_frame>
        <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for NPI.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O2">
            <title>Lanabecestat 20 mg</title>
            <description>Participants received lanabecestat 20 mg film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O3">
            <title>Lanabecestat 50 mg</title>
            <description>Participants received lanabecestat 50 mg film-coated oral tablets once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Neuropsychiatric Inventory (NPI) Score</title>
          <description>The NPI is a questionnaire administered to caregivers that quantifies behavioral changes. Each of the 12 behavioral domains the caregiver reports as present are scored for Frequency, scale: 1 (Occasionally) to 4 (Very Frequently), and Severity, scale: 1 (Mild) to 3 (Severe). If the domain is reported by the caregiver as 'Not Affected,' that domain is scored as 0. The individual domain scores are calculated by multiplying the frequency times the severity for each domain. NPI Total Score is calculated by adding the individual domain scores together for all 12 domains, with a scores range from 0 to 144, with higher scores indicating greater severity of neuropsychiatric disturbance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline NPI score, age at baseline, and baseline NPI score-by-visit interaction.</description>
          <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for NPI.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="697"/>
                <count group_id="O2" value="695"/>
                <count group_id="O3" value="663"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.22" spread="0.81"/>
                    <measurement group_id="O2" value="4.99" spread="0.83"/>
                    <measurement group_id="O3" value="4.67" spread="0.85"/>
                  </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>0.116</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>1.77</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.13</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.441</ci_lower_limit>
            <ci_upper_limit>3.986</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.208</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>1.45</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.15</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.808</ci_lower_limit>
            <ci_upper_limit>3.704</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on the Mini-Mental State Examination (MMSE)</title>
        <description>The MMSE is an instrument used to assess a participant's global cognitive function. The MMSE assesses orientation to time and place, immediate and delayed recall of words, attention and calculation, language (naming, comprehension and repetition), and spatial ability (copying a figure). The range for MMSE total Score is 0 to 30, with a higher score indicating better cognitive performance. LS mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline MMSE total score, age at baseline, and baseline MMSE total score-by-visit interaction.</description>
        <time_frame>Baseline, Week 104</time_frame>
        <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for MMSE.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O2">
            <title>Lanabecestat 20 mg</title>
            <description>Participants received lanabecestat 20 mg film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O3">
            <title>Lanabecestat 50 mg</title>
            <description>Participants received lanabecestat 50 mg film-coated oral tablets once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the Mini-Mental State Examination (MMSE)</title>
          <description>The MMSE is an instrument used to assess a participant's global cognitive function. The MMSE assesses orientation to time and place, immediate and delayed recall of words, attention and calculation, language (naming, comprehension and repetition), and spatial ability (copying a figure). The range for MMSE total Score is 0 to 30, with a higher score indicating better cognitive performance. LS mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline MMSE total score, age at baseline, and baseline MMSE total score-by-visit interaction.</description>
          <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for MMSE.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="723"/>
                <count group_id="O2" value="725"/>
                <count group_id="O3" value="709"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.50" spread="0.26"/>
                    <measurement group_id="O2" value="-5.18" spread="0.26"/>
                    <measurement group_id="O3" value="-5.49" 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>0.379</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>0.32</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.36</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.391</ci_lower_limit>
            <ci_upper_limit>1.027</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.992</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>0.00</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.37</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.714</ci_lower_limit>
            <ci_upper_limit>0.721</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacodynamics (PD): Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aβ)1-42</title>
        <description>Concentration of the peptide Aβ 1-42 in plasma measured by validated immunoassay. LS Mean was determined by Analysis of covariance (ANCOVA) with last observation carried forward (LOCF), terms for treatment, baseline biomarker and age at baseline.</description>
        <time_frame>Baseline, Week 97</time_frame>
        <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for Aβ1-42.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O2">
            <title>Lanabecestat 20 mg</title>
            <description>Participants received lanabecestat 20 mg film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O3">
            <title>Lanabecestat 50 mg</title>
            <description>Participants received lanabecestat 50 mg film-coated oral tablets once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacodynamics (PD): Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aβ)1-42</title>
          <description>Concentration of the peptide Aβ 1-42 in plasma measured by validated immunoassay. LS Mean was determined by Analysis of covariance (ANCOVA) with last observation carried forward (LOCF), terms for treatment, baseline biomarker and age at baseline.</description>
          <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for Aβ1-42.</population>
          <units>Percent change in Aβ1-42</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="66"/>
                <count group_id="O3" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.64" spread="2.07"/>
                    <measurement group_id="O2" value="-53.91" spread="2.04"/>
                    <measurement group_id="O3" value="-68.13" spread="1.87"/>
                  </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>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-51.27</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.89</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-56.963</ci_lower_limit>
            <ci_upper_limit>-45.578</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-65.48</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.77</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-70.947</ci_lower_limit>
            <ci_upper_limit>-60.022</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PD: Percent Change From Baseline in Concentration of CSF Biomarker Aβ1-40</title>
        <description>Concentration of the peptide Aβ 1-40 in plasma measured by immunoassay. LS Mean was determined by ANCOVA with LOCF (last observation carried forward), terms for treatment, baseline biomarker and age at baseline.</description>
        <time_frame>Baseline, Week 97</time_frame>
        <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for Aβ1-40.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O2">
            <title>Lanabecestat 20 mg</title>
            <description>Participants received lanabecestat 20 mg film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O3">
            <title>Lanabecestat 50 mg</title>
            <description>Participants received lanabecestat 50 mg film-coated oral tablets once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>PD: Percent Change From Baseline in Concentration of CSF Biomarker Aβ1-40</title>
          <description>Concentration of the peptide Aβ 1-40 in plasma measured by immunoassay. LS Mean was determined by ANCOVA with LOCF (last observation carried forward), terms for treatment, baseline biomarker and age at baseline.</description>
          <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for Aβ1-40.</population>
          <units>Percent change in Aβ1-40</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="66"/>
                <count group_id="O3" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.92" spread="1.77"/>
                    <measurement group_id="O2" value="-59.90" spread="1.74"/>
                    <measurement group_id="O3" value="-75.17" spread="1.60"/>
                  </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>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-57.99</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.47</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-62.865</ci_lower_limit>
            <ci_upper_limit>-53.108</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-73.25</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.37</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-77.926</ci_lower_limit>
            <ci_upper_limit>-68.575</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CSF Total Tau</title>
        <description>Cerebrospinal fluid samples are collected for analysis of concentration total tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.</description>
        <time_frame>Baseline, Week 97</time_frame>
        <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for CSF Total Tau.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O2">
            <title>Lanabecestat 20 mg</title>
            <description>Participants received lanabecestat 20 mg film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O3">
            <title>Lanabecestat 50 mg</title>
            <description>Participants received lanabecestat 50 mg film-coated oral tablets once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CSF Total Tau</title>
          <description>Cerebrospinal fluid samples are collected for analysis of concentration total tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.</description>
          <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for CSF Total Tau.</population>
          <units>Picogram per milliliter (pg/mL)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="66"/>
                <count group_id="O3" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.39" spread="8.05"/>
                    <measurement group_id="O2" value="-7.48" spread="8.01"/>
                    <measurement group_id="O3" value="-2.92" spread="7.30"/>
                  </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>0.081</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-19.87</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>11.33</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-42.210</ci_lower_limit>
            <ci_upper_limit>2.464</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.157</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-15.31</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>10.78</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-36.555</ci_lower_limit>
            <ci_upper_limit>5.938</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CSF Phosphorylated Tau</title>
        <description>Cerebrospinal fluid samples are collected for analysis of concentrations of phosphorylated tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.</description>
        <time_frame>Baseline, Week 97</time_frame>
        <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for CSF Phosphorylated Tau.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O2">
            <title>Lanabecestat 20 mg</title>
            <description>Participants received lanabecestat 20 mg film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O3">
            <title>Lanabecestat 50 mg</title>
            <description>Participants received lanabecestat 50 mg film-coated oral tablets once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CSF Phosphorylated Tau</title>
          <description>Cerebrospinal fluid samples are collected for analysis of concentrations of phosphorylated tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.</description>
          <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for CSF Phosphorylated Tau.</population>
          <units>Picogram per milliliter (pg/mL)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="66"/>
                <count group_id="O3" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.47" spread="0.95"/>
                    <measurement group_id="O2" value="-2.16" spread="0.94"/>
                    <measurement group_id="O3" value="-1.66" spread="0.85"/>
                  </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>0.050</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-2.62</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.33</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.243</ci_lower_limit>
            <ci_upper_limit>-0.002</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.095</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-2.12</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.27</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.618</ci_lower_limit>
            <ci_upper_limit>0.373</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Brain Amyloid Burden Using Florbetapir Amyloid Positron Emission Tomography (PET) Scan</title>
        <description>Amyloid deposition in the brain is one of the defining neuropathologic findings of Alzheimer's disease. Florbetapir exhibits high affinity specific binding to amyloid plaques. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by florbetapir amyloid PET imaging in a subset of participants. The Centiloid scale standardizes quantitative brain amyloid PET results to allow cross-tracer and cross-methodology comparisons. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scans. Florbetapir SUVr was converted to the Centiloid scale using the following conversion: Florbetapir Centiloids = 183 x SUVr - 177. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.</description>
        <time_frame>Baseline, Week 104</time_frame>
        <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for brain amyloid burden.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O2">
            <title>Lanabecestat 20 mg</title>
            <description>Participants received lanabecestat 20 mg film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O3">
            <title>Lanabecestat 50 mg</title>
            <description>Participants received lanabecestat 50 mg film-coated oral tablets once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Brain Amyloid Burden Using Florbetapir Amyloid Positron Emission Tomography (PET) Scan</title>
          <description>Amyloid deposition in the brain is one of the defining neuropathologic findings of Alzheimer's disease. Florbetapir exhibits high affinity specific binding to amyloid plaques. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by florbetapir amyloid PET imaging in a subset of participants. The Centiloid scale standardizes quantitative brain amyloid PET results to allow cross-tracer and cross-methodology comparisons. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scans. Florbetapir SUVr was converted to the Centiloid scale using the following conversion: Florbetapir Centiloids = 183 x SUVr - 177. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.</description>
          <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for brain amyloid burden.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="133"/>
                <count group_id="O2" value="127"/>
                <count group_id="O3" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.08" spread="1.86"/>
                    <measurement group_id="O2" value="-15.76" spread="1.89"/>
                    <measurement group_id="O3" value="-19.74" spread="1.97"/>
                  </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>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-13.68</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.60</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.785</ci_lower_limit>
            <ci_upper_limit>-8.574</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-17.66</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.66</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-22.887</ci_lower_limit>
            <ci_upper_limit>-12.428</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Tau PET ((Flortaucipir F18)</title>
        <description>Tau PET tracer (flortaucipir F18) longitudinal study measured whether lanabecestat, in participants with mild AD dementia, affected tau density and distribution over time. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the signal intensity in white matter. Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline. Baseline defined to be within 28 days of starting study drug.</description>
        <time_frame>Baseline, Week 104</time_frame>
        <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for Tau PET.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O2">
            <title>Lanabecestat 20 mg</title>
            <description>Participants received lanabecestat 20 mg film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O3">
            <title>Lanabecestat 50 mg</title>
            <description>Participants received lanabecestat 50 mg film-coated oral tablets once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Tau PET ((Flortaucipir F18)</title>
          <description>Tau PET tracer (flortaucipir F18) longitudinal study measured whether lanabecestat, in participants with mild AD dementia, affected tau density and distribution over time. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the signal intensity in white matter. Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline. Baseline defined to be within 28 days of starting study drug.</description>
          <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for Tau PET.</population>
          <units>Standard Uptake Value ratio (SUVr)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="94"/>
                <count group_id="O3" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.01"/>
                    <measurement group_id="O2" value="0.03" spread="0.01"/>
                    <measurement group_id="O3" value="0.03" spread="0.01"/>
                  </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>0.426</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-0.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.01</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.033</ci_lower_limit>
            <ci_upper_limit>0.014</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.660</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-0.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.01</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.029</ci_lower_limit>
            <ci_upper_limit>0.018</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Brain Metabolism Using Fluorodeoxyglucose (FDG)</title>
        <description>Fluorodeoxyglucose (FDG) PET evaluates the regional brain metabolic rates for glucose as a sensitive, in vivo metabolic index of brain function. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the pons + vermis assessed with composite meta and composite meta automated anatomical labeling atlas (ALL). Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline. Baseline defined to be within 28 days of starting study drug.</description>
        <time_frame>Baseline, Week 104</time_frame>
        <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data of brain metabolism.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O2">
            <title>Lanabecestat 20 mg</title>
            <description>Participants received lanabecestat 20 mg film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O3">
            <title>Lanabecestat 50 mg</title>
            <description>Participants received lanabecestat 50 mg film-coated oral tablets once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Brain Metabolism Using Fluorodeoxyglucose (FDG)</title>
          <description>Fluorodeoxyglucose (FDG) PET evaluates the regional brain metabolic rates for glucose as a sensitive, in vivo metabolic index of brain function. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the pons + vermis assessed with composite meta and composite meta automated anatomical labeling atlas (ALL). Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline. Baseline defined to be within 28 days of starting study drug.</description>
          <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data of brain metabolism.</population>
          <units>Standard Uptake Value ratio (SUVr)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.00"/>
                    <measurement group_id="O2" value="-0.05" spread="0.00"/>
                    <measurement group_id="O3" value="-0.05" spread="0.00"/>
                  </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>0.210</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-0.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.00</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.015</ci_lower_limit>
            <ci_upper_limit>0.003</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.568</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-0.00</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.00</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.013</ci_lower_limit>
            <ci_upper_limit>0.007</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Whole Brain Volume</title>
        <description>Magnetic resonance imaging (MRI) was used to evaluate the effect of lanabecestat on whole brain volumes. Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, baseline vMRI, intracranial volume, disease status at baseline and age at baseline.</description>
        <time_frame>Baseline, Week 104</time_frame>
        <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for Whole Brain Volume.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O2">
            <title>Lanabecestat 20 mg</title>
            <description>Participants received lanabecestat 20 mg film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O3">
            <title>Lanabecestat 50 mg</title>
            <description>Participants received lanabecestat 50 mg film-coated oral tablets once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Whole Brain Volume</title>
          <description>Magnetic resonance imaging (MRI) was used to evaluate the effect of lanabecestat on whole brain volumes. Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, baseline vMRI, intracranial volume, disease status at baseline and age at baseline.</description>
          <population>All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for Whole Brain Volume.</population>
          <units>cm^3 (cubic centimeter)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="565"/>
                <count group_id="O2" value="582"/>
                <count group_id="O3" value="550"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.16" spread="0.34"/>
                    <measurement group_id="O2" value="-16.49" spread="0.33"/>
                    <measurement group_id="O3" value="-17.34" spread="0.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-2.34</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.47</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.258</ci_lower_limit>
            <ci_upper_limit>-1.413</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference (Final Values)</param_type>
            <param_value>-3.18</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.48</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.118</ci_lower_limit>
            <ci_upper_limit>-2.247</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): Plasma Concentration of Lanabecestat</title>
        <time_frame>Week 4, post dose prior to departure from the clinic</time_frame>
        <population>All randomized participants who received at least one dose of study drug and have evaluable PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Lanabecestat 20 mg</title>
            <description>Participants received lanabecestat 20 mg film-coated oral tablets once daily.</description>
          </group>
          <group group_id="O2">
            <title>Lanabecestat 50 mg</title>
            <description>Participants received lanabecestat 50 mg film-coated oral tablets once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Plasma Concentration of Lanabecestat</title>
          <population>All randomized participants who received at least one dose of study drug and have evaluable PK data.</population>
          <units>nanograms per milliliter (ng/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="697"/>
                <count group_id="O2" value="662"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.7" spread="49.1"/>
                    <measurement group_id="O2" value="213" spread="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up To 104 weeks</time_frame>
      <desc>All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received placebo film-coated oral tablets once daily.</description>
        </group>
        <group group_id="E2">
          <title>Lanabecestat 20 mg</title>
          <description>Participants received lanabecestat 20 mg film-coated oral tablets once daily.</description>
        </group>
        <group group_id="E3">
          <title>Lanabecestat 50 mg</title>
          <description>Participants received lanabecestat 50 mg film-coated oral tablets once daily.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="736"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="108" subjects_at_risk="738"/>
                <counts group_id="E2" subjects_affected="117" subjects_at_risk="736"/>
                <counts group_id="E3" subjects_affected="147" subjects_at_risk="735"/>
              </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="3" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Bifascicular block</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="736"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Cardiac tamponade</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Coronary artery thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="738"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Sinus node dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Stress cardiomyopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Supraventricular extrasystoles</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Tricuspid valve incompetence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal arteriovenous malformation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vestibular disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="736"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Pterygium</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Retinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Alcoholic pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Anal incontinence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Coeliac artery stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Colitis microscopic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Enlarged uvula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Faecaloma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Femoral hernia incarcerated</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="736"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Intestinal mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Rectal prolapse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="736"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Bone abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Hepatic cyst infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Human anaplasmosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="736"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Intervertebral discitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Ophthalmic herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Peritonsillitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="738"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="736"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Septic arthritis streptococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Urinary tract infection pseudomonal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Vestibular neuronitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Accidental poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Alcohol poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Cervical vertebral fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Chemical burn of gastrointestinal tract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="738"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="736"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Fibula fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Forearm fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="736"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Jaw fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Lacrimal structure injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Ligament rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Periprosthetic fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Pubis fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Skull fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Subdural haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Ulna fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood potassium decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="736"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Electrolyte imbalance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Lactic acidosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Bone lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Foot deformity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Infrapatellar fat pad inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Intervertebral disc compression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Mobility decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Myofascial pain syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="738"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Osteolysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Osteoporotic fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Spinal column stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Vertebral foraminal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acoustic neuroma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Acute myeloid leukaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Bile duct adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Bladder neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Breast cancer male</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="341"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="344"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="354"/>
              </event>
              <event>
                <sub_title>Breast cancer recurrent</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Endometrial adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="397"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="392"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="381"/>
              </event>
              <event>
                <sub_title>Haemangioma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Invasive ductal breast carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="736"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Laryngeal squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Lentigo maligna</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Lung neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Malignant melanoma in situ</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Malignant neoplasm of unknown primary site</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Metastases to bone</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Metastases to lymph nodes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Neuroendocrine tumour</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Ovarian adenoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="397"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="392"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="381"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="341"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="344"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="354"/>
              </event>
              <event>
                <sub_title>Prostatic adenoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="341"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="344"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="354"/>
              </event>
              <event>
                <sub_title>Rectal adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Rectal adenoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Rectal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Small cell lung cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Altered state of consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Central nervous system lesion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Cerebral haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Cerebral microhaemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Cervical radiculopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Cholinergic syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Cognitive disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Dementia with lewy bodies</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Dyskinesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Generalised tonic-clonic seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Hypertensive encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Intraventricular haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Partial seizures</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Petit mal epilepsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="736"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Thalamic infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="736"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Ulnar nerve palsy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Vasogenic cerebral oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Vocal cord paresis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal behaviour</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Acute psychosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Aggression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="736"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Depressive symptom</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Hallucination</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Hallucination, auditory</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Hallucination, olfactory</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Paranoia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Schizophrenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Calculus bladder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Urge incontinence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="341"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="344"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="354"/>
              </event>
              <event>
                <sub_title>Postmenopausal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="397"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="392"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="381"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Cystic lung disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Obstructive airways disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Respiratory arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Stridor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Drug eruption</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Cardiac pacemaker insertion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Cataract operation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Hip arthroplasty</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Inguinal hernia repair</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Spinal operation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Synovial cyst removal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Tumour excision</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Urethral repair</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Vocal cord operation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Granulomatosis with polyangiitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="738"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Peripheral artery stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Temporal arteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="736"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Venous thrombosis limb</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="738"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="736"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="340" subjects_at_risk="738"/>
                <counts group_id="E2" subjects_affected="357" subjects_at_risk="736"/>
                <counts group_id="E3" subjects_affected="361" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="44" subjects_affected="39" subjects_at_risk="738"/>
                <counts group_id="E2" events="81" subjects_affected="62" subjects_at_risk="736"/>
                <counts group_id="E3" events="62" subjects_affected="54" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="38" subjects_affected="32" subjects_at_risk="738"/>
                <counts group_id="E2" events="39" subjects_affected="33" subjects_at_risk="736"/>
                <counts group_id="E3" events="50" subjects_affected="41" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="69" subjects_affected="60" subjects_at_risk="738"/>
                <counts group_id="E2" events="94" subjects_affected="78" subjects_at_risk="736"/>
                <counts group_id="E3" events="89" subjects_affected="76" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="57" subjects_affected="46" subjects_at_risk="738"/>
                <counts group_id="E2" events="43" subjects_affected="39" subjects_at_risk="736"/>
                <counts group_id="E3" events="50" subjects_affected="44" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="70" subjects_affected="56" subjects_at_risk="738"/>
                <counts group_id="E2" events="53" subjects_affected="36" subjects_at_risk="736"/>
                <counts group_id="E3" events="36" subjects_affected="32" subjects_at_risk="735"/>
              </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="86" subjects_affected="69" subjects_at_risk="738"/>
                <counts group_id="E2" events="95" subjects_affected="71" subjects_at_risk="736"/>
                <counts group_id="E3" events="111" subjects_affected="73" subjects_at_risk="735"/>
              </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="50" subjects_affected="40" subjects_at_risk="738"/>
                <counts group_id="E2" events="38" subjects_affected="36" subjects_at_risk="736"/>
                <counts group_id="E3" events="35" subjects_affected="33" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="48" subjects_affected="42" subjects_at_risk="738"/>
                <counts group_id="E2" events="52" subjects_affected="43" subjects_at_risk="736"/>
                <counts group_id="E3" events="61" subjects_affected="51" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="56" subjects_affected="52" subjects_at_risk="738"/>
                <counts group_id="E2" events="50" subjects_affected="40" subjects_at_risk="736"/>
                <counts group_id="E3" events="72" subjects_affected="46" subjects_at_risk="735"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="40" subjects_affected="34" subjects_at_risk="738"/>
                <counts group_id="E2" events="63" subjects_affected="57" subjects_at_risk="736"/>
                <counts group_id="E3" events="50" subjects_affected="48" subjects_at_risk="735"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="32" subjects_affected="31" subjects_at_risk="738"/>
                <counts group_id="E2" events="39" subjects_affected="36" subjects_at_risk="736"/>
                <counts group_id="E3" events="49" subjects_affected="46" subjects_at_risk="735"/>
              </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="25" subjects_affected="25" subjects_at_risk="738"/>
                <counts group_id="E2" events="49" subjects_affected="46" subjects_at_risk="736"/>
                <counts group_id="E3" events="29" subjects_affected="25" subjects_at_risk="735"/>
              </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 sponsor shall review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60days but less than or equal to 180days from the time submitted to the sponsor.Authors agree not to publish results until data is compiled. No publication/presentation with respect to the research activities shall be made unless &amp; until any information determined at sponsors sole discretion to be confidential information has been removed.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>AstraZeneca Information Center</name_or_title>
      <organization>AstraZeneca</organization>
      <phone>1-877-240-9479</phone>
      <email>information.center@astrazeneca.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/NCT02245737
org study id: 16023
secondary id: I8D-MC-AZES
secondary id: 2014-002601-38
secondary id: D5010C00009
nct id: NCT02245737
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to assess the efficacy and safety of lanabecestat compared with
      placebo administered for 104 weeks in the treatment of early Alzheimer´s disease. The study
      will test the hypothesis that lanabecestat is a disease-modifying treatment for participants
      with early Alzheimer´s disease, defined as the continuum of participants with mild cognitive
      impairment (MCI) due to Alzheimer´s disease and participants diagnosed with mild dementia of
      the Alzheimer´s type, as measured by change from baseline on the 13-item Alzheimer's Disease
      Assessment Scale - Cognitive Subscale (ADAS-Cog13) score at week 104 in each of the 2
      lanabecestat treatment groups compared with placebo.
Participants who meet other study entry requirements will be required to undergo either an
      amyloid positron emission tomography (PET) scan or a lumbar puncture for cerebrospinal fluid
      (CSF) sampling at screening to document presence of abnormal levels of brain and CSF amyloid
      for study inclusion. The study includes 2 sub-studies: the participants that undergo a PET
      scan at screening will be included in the PET-substudy, and participants who undergo a lumbar
      puncture at screening will be included in the CSF substudy until each of these substudies are
      completed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
time frame: Baseline, Week 104
description: ADAS-Cog13 (13-item version of ADAS-Cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, pooled country, and covariates for baseline ADAS-Cog13 total score, age at baseline, and baseline ADAS-Cog13 total score-by-visit interaction.
measure: Change From Baseline on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)
time frame: Baseline, Week 104
description: The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean was determined by MMRM model with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline for baseline iADL score, age at baseline, and baseline iADL score-by-visit interaction.
measure: Change From Baseline on the Functional Activities Questionnaire (FAQ) Score
time frame: Baseline, Week 104
description: FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from writing checks, assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did [the activity] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3). FAQ scale is 0 to 30, with higher scores indicating greater impairment. LS Mean was calculated by MMRM with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline and pooled country.
measure: Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score
time frame: Baseline, Week 104
description: The iADRS is a composite that measures both cognition and function. The iADRS comprises scores form the ADAS- Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 (score range 0 to 85 with higher scores reflecting worse performance) and the ADCS-iADL (score range from 0-59 with higher scores reflecting better performance). The iADRS score ranges from 0 to 144 with higher scores indicating greater impairment. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by- visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline iADRS13 total score, age at baseline, and baseline iADRS13 total score-by-visit interaction.
measure: Change From Baseline on the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score
time frame: Baseline, Week 104
description: The CDR-SB is a rater administered scale and impairment is scored in of the following categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which no dementia = 0, questionable dementia = 0.5, mild dementia = 1, moderate dementia = 2 and severe dementia = 3. The 6 individual category ratings, or "box scores", were added together to give the CDR-Sum of Boxes which ranges from 0-18, with higher scores indicating greater impairment. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline CDR-SB score, age at baseline, and baseline CDR-SB score-by-visit interaction.
measure: Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage
time frame: Baseline through Loss of 1 Global Stage or Week 104
description: The CDR global score is a composite score calculated using the Washington University CDR-assignment algorithm applied to the 6 individual domain box scores (Morris 1993). The memory domain is considered the primary category that drives the CDR global outcome, and all other domains are secondary. The CDR global score ranges from 0 to 3 (0 = no dementia, 0.5 = questionable dementia, 1 = mild dementia, 2 = moderate dementia, 3 = severe dementia).
measure: Change From Baseline in Neuropsychiatric Inventory (NPI) Score
time frame: Baseline, Week 104
description: The NPI is a questionnaire administered to caregivers that quantifies behavioral changes. Each of the 12 behavioral domains the caregiver reports as present are scored for Frequency, scale: 1 (Occasionally) to 4 (Very Frequently), and Severity, scale: 1 (Mild) to 3 (Severe). If the domain is reported by the caregiver as 'Not Affected,' that domain is scored as 0. The individual domain scores are calculated by multiplying the frequency times the severity for each domain. NPI Total Score is calculated by adding the individual domain scores together for all 12 domains, with a scores range from 0 to 144, with higher scores indicating greater severity of neuropsychiatric disturbance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline NPI score, age at baseline, and baseline NPI score-by-visit interaction.
measure: Change From Baseline on the Mini-Mental State Examination (MMSE)
time frame: Baseline, Week 104
description: The MMSE is an instrument used to assess a participant's global cognitive function. The MMSE assesses orientation to time and place, immediate and delayed recall of words, attention and calculation, language (naming, comprehension and repetition), and spatial ability (copying a figure). The range for MMSE total Score is 0 to 30, with a higher score indicating better cognitive performance. LS mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline MMSE total score, age at baseline, and baseline MMSE total score-by-visit interaction.
measure: Pharmacodynamics (PD): Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aβ)1-42
time frame: Baseline, Week 97
description: Concentration of the peptide Aβ 1-42 in plasma measured by validated immunoassay. LS Mean was determined by Analysis of covariance (ANCOVA) with last observation carried forward (LOCF), terms for treatment, baseline biomarker and age at baseline.
measure: PD: Percent Change From Baseline in Concentration of CSF Biomarker Aβ1-40
time frame: Baseline, Week 97
description: Concentration of the peptide Aβ 1-40 in plasma measured by immunoassay. LS Mean was determined by ANCOVA with LOCF (last observation carried forward), terms for treatment, baseline biomarker and age at baseline.
measure: Change From Baseline in CSF Total Tau
time frame: Baseline, Week 97
description: Cerebrospinal fluid samples are collected for analysis of concentration total tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.
measure: Change From Baseline in CSF Phosphorylated Tau
time frame: Baseline, Week 97
description: Cerebrospinal fluid samples are collected for analysis of concentrations of phosphorylated tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.
measure: Change From Baseline in Brain Amyloid Burden Using Florbetapir Amyloid Positron Emission Tomography (PET) Scan
time frame: Baseline, Week 104
description: Amyloid deposition in the brain is one of the defining neuropathologic findings of Alzheimer's disease. Florbetapir exhibits high affinity specific binding to amyloid plaques. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by florbetapir amyloid PET imaging in a subset of participants. The Centiloid scale standardizes quantitative brain amyloid PET results to allow cross-tracer and cross-methodology comparisons. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scans. Florbetapir SUVr was converted to the Centiloid scale using the following conversion: Florbetapir Centiloids = 183 x SUVr - 177. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.
measure: Change From Baseline in Tau PET ((Flortaucipir F18)
time frame: Baseline, Week 104
description: Tau PET tracer (flortaucipir F18) longitudinal study measured whether lanabecestat, in participants with mild AD dementia, affected tau density and distribution over time. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the signal intensity in white matter. Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline. Baseline defined to be within 28 days of starting study drug.
measure: Change From Baseline in Brain Metabolism Using Fluorodeoxyglucose (FDG)
time frame: Baseline, Week 104
description: Fluorodeoxyglucose (FDG) PET evaluates the regional brain metabolic rates for glucose as a sensitive, in vivo metabolic index of brain function. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the pons + vermis assessed with composite meta and composite meta automated anatomical labeling atlas (ALL). Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline. Baseline defined to be within 28 days of starting study drug.
measure: Change From Baseline in Whole Brain Volume
time frame: Baseline, Week 104
description: Magnetic resonance imaging (MRI) was used to evaluate the effect of lanabecestat on whole brain volumes. Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, baseline vMRI, intracranial volume, disease status at baseline and age at baseline.
measure: Pharmacokinetics (PK): Plasma Concentration of Lanabecestat
time frame: Week 4, post dose prior to departure from the clinic
arm group label: Lanabecestat 20 milligrams (mg)
arm group type: Experimental
description: Lanabecestat 20 mg given orally once daily for 104 weeks.
arm group label: Lanabecestat 50 mg
arm group type: Experimental
description: Lanabecestat 50 mg given orally once daily for 104 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo given orally once daily for 104 weeks.
intervention type: Drug
intervention name: Lanabecestat
description: Administered orally
arm group label: Lanabecestat 20 milligrams (mg)
arm group label: Lanabecestat 50 mg
other name: LY3314814
other name: AZD3293
intervention type: Drug
intervention name: Placebo
description: Administered orally
arm group label: Placebo
criteria: 
gender: All
minimum age: 55 Years
maximum age: 85 Years
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon- Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
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country: Australia
country: Belgium
country: Canada
country: France
country: Germany
country: Hungary
country: Italy
country: Japan
country: Korea, Republic of
country: Poland
country: Puerto Rico
country: Romania
country: Spain
country: United Kingdom
country: United States
country: Argentina
country: Czech Republic
country: Sweden
url: https://www.lillytrialguide.com/en-US/studies/mild-alzheimer-s-disease/AZES#?postal=
description: Click here for more information about this study: An Efficacy and Safety Study of LY3314814 in Early Alzheimer's Disease
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=16023&amp;attachmentIdentifier=f8802097-b8c3-4396-ad08-8df8ca98325d&amp;fileName=CSP_NCT02245737.pdf&amp;versionIdentifier=
description: CSP
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=16023&amp;attachmentIdentifier=5c8b319d-5e9f-4b1d-b366-d589b53774a8&amp;fileName=SAP_NCT02245737.pdf&amp;versionIdentifier=
description: SAP
responsible party type: Sponsor
mesh term: Alzheimer Disease
sharing ipd: Yes
ipd description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
ipd access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
ipd url: https://www.clinicalstudydatarequest.com/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility.
point of contact: 